ChiCTR2500097943 版本V1.0 版本创建时间2025/02/27 15:48:26 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500097943 

最近更新日期：

Date of Last Refreshed on：

 2025-02-27 15:48:11 

注册时间：

Date of Registration：

 2025-02-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

评估IBI110联合信迪利单抗治疗晚期转移或不可切除腺泡状软组织肉瘤（IV期）的有效性和安全性的单中心II期临床研究

Public title：

A single-center phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with sintilimab in the treatment of advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV).

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估IBI110联合信迪利单抗治疗晚期转移或不可切除腺泡状软组织肉瘤（IV期）的有效性和安全性的单中心II期临床研究

Scientific title：

A single-center phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with sintilimab in the treatment of advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV).

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

谭智超 

研究负责人：

刘佳勇 

Applicant：

Zhichao Tan 

Study leader：

Jiayong Liu 

申请注册联系人电话：

Applicant telephone：

 +86 10 8819 6745

研究负责人电话：

Study leader's
telephone：

+86 10 8819 6745

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 zhichaotan@pku.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 liujiayong@aliyun.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市海淀区阜成路52号

研究负责人通讯地址：

北京市海淀区阜成路52号

Applicant address：

No. 52 Fucheng Road, Haidian District, Beijing

Study leader's address：

No. 52 Fucheng Road, Haidian District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京肿瘤医院

Applicant's institution：

Beijing Cancer Hospital

研究负责人所在单位：

北京肿瘤医院

Affiliation of the Leader：

Beijing Cancer Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2022YJZ02

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

北京肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-02-21 00:00:00

伦理委员会联系人：

李洁

Contact Name of the ethic committee：

Jie Li

伦理委员会联系地址：

北京市海淀区阜成路52号

Contact Address of the ethic committee：

No. 52 Fucheng Road, Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8819 6391

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

北京肿瘤医院

Primary sponsor：

Beijing Cancer Hospital

研究实施负责（组长）单位地址：

北京市海淀区阜成路52号

Primary sponsor's address：

No. 52 Fucheng Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京肿瘤医院

具体地址：

北京市海淀区阜成路52号

Institution
hospital：

Beijing Cancer Hospital

Address：

No. 52 Fucheng Road, Haidian District, Beijing

经费或物资来源：

信达生物制药（苏州）有限公司

Source(s) of funding：

Innovent Biologics(Suzhou)CO,Ltd

研究疾病：

腺泡状软组织肉瘤  

Target disease：

Alveolar Soft Part Sarcoma

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

评估IBI110联合信迪利单抗治疗晚期转移或不可切除腺泡状软组织肉瘤（IV期）的疗效（基于RECIST v1.1由研究者评估的客观缓解率[Objective Response Rate, ORR]及无进展生存期[Progression Free Survival, PFS]）； 评估IBI110联合信迪利单抗在晚期转移或不可切除腺泡状软组织肉瘤（IV期）受试者中的安全性和耐受性。 评估IBI110联合信迪利单抗治疗晚期转移或不可切除腺泡状软组织肉瘤（IV期）的其他疗效，包括：总生存期（Overall Survival, OS）、疾病控制率（Disease Control Rate, DCR）、缓解持续时间（Duration of Response, DoR）和至缓解时间（Time to Response, TTR）。 探索使用iRECIST标准评估IBI110联合信迪利单抗治疗晚期转移或不可切除腺泡状软组织肉瘤（IV期）的疗效。  

Objectives of Study：

To evaluate the efficacy of IBI110 in combination with sintilimab in the treatment of advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) (Objective response rate [ORR] and progression free survival [PFS] as assessed by investigators based on RECIST v1.1); To evaluate the safety and tolerability of IBI110 in combination with sintilimab in subjects with advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV). To assess the additional efficacy of IBI110 in combination with sintilimab in the treatment of advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV), including overall survival (OS), disease control rate (DCR), duration of response (DoR), and time to response (TTR). To explore the use of iRECIST criteria to evaluate the efficacy of IBI110 in combination with sintilimab in the treatment of advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

入组标准： 队列A：既往未接受过免疫治疗的晚期转移或不可切除腺泡状软组织肉瘤（IV 期） 1） 经病理学确诊的晚期转移或不可切除腺泡状软组织肉瘤（IV期）患者（按照第8版美国癌症联合会[American Joint Committee on Cancer，AJCC]分期）； 2） 未接受过 T 细胞免疫检查点抑制剂（包括且不限于抗 PD-1/PD-L1单抗、抗CTLA-4 单抗）治疗； 3） 首次给药前4 周之内未接受过针对肿瘤的局部治疗； 4） 既往有无接受全身化疗或靶向治疗均可。 队列 B：免疫治疗失败的晚期转移或不可切除腺泡状软组织肉瘤（IV期） 1） 经病理学确诊的晚期转移或不可切除腺泡状软组织肉瘤（IV期）患者（按照第8版美国癌症联合会[American Joint Committee on Cancer，AJCC]分期）； 2） 既往接受过抗PD-1/PD-L1 抗体类药物治疗后出现经影像学确认的疾病进展； 3） 首次给药前4 周之内未接受过针对肿瘤的局部治疗。 4） 既往有无接受全身化疗或靶向治疗均可。 队列A 和队列B 共同需要满足的入组标准： 1） 签署书面知情同意书（Informed Consent Form, ICF），并且能够遵守方案规定的访视及相关程序； 2） 年龄≥18岁的男性或女性； 3） 预期生存时间≥12周； 4） 根据RECIST v1.1标准，存在至少1个可测量病灶，基线时经计算机断层扫描（CT）或磁共振成像（MRI）（首选静脉注射造影剂）准确测量显示其长直径≥10mm（淋巴结除外，淋巴结的短轴必须 ≥15mm），且病灶适合反复准确测量；如果是位于既往接受过照射区域的病灶，明确证明出现进展，则该病灶可作为靶病灶； 5） 美国东部肿瘤协作组体力状态评分（Eastern Cooperative Oncology Group Performance Status, ECOG PS）为0或1分； 6） 具有充分的器官和骨髓功能（研究药物首次给药前2周内使用任何细胞及生长因子治疗、红细胞或血小板输注等输血治疗的受试者应除外），定义如下： 血常规：绝对中性粒细胞计数（Absolute Neutrophil Count, ANC） ≥1.5×109/L或处于正常范围内；血小板（Platelet, PLT）计数 ≥100×109/L；血红蛋白含量（Hemoglobin, HGB）≥9.0g/dL； 7） 肝功能：血清总胆红素（Total Bilirubin, TBIL）≤1.5×正常值上限（Upper Limit of Normal Value, ULN）；对于无肝转移的受试者， 丙 氨酸氨基转移酶（Alanine Aminotransferase, ALT）和天门冬氨酸 8） 肾功能：血清肌酐（Creatinine, Cr）≤1.5×ULN或肌酐清除率（Clearance of Creatinine, CCr）≥50mL/min，采用Cockcroft-Gault公式计算的CCr（使用实际体重）； 9） 尿常规：尿蛋白＜2+；对基线时尿试纸检测显示尿蛋白≥2+的受试者，应进行24小时尿液采集且24小时内尿液中的蛋白含量＜1g（如果两种检测方法都被采用，则将使用24小时尿液采集结果确定资格）； 10）凝血功能：活化部分凝血活酶时间（Activated Partial Thromboplastin Time, APTT ） ≤1.5×ULN 和国 际标 准化比 率（ International Normalized Ratio, INR）≤1.5。 11）育龄期女性受试者或伴侣为育龄期妇女的男性受试者，需在整个治疗期及治疗期后180天内采取有效的避孕措施。

Inclusion criteria

Enrollment Criteria: Cohort A: Previously immunotherapy-na?ve advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) 1) Patients with pathologically confirmed advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) (according to the 8th edition of the American Joint Committee on Cancer [AJCC] stage); 2) have not been treated with T-cell immune checkpoint inhibitors (including but not limited to anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies); 3) Have not received local therapy for tumor within 4 weeks before the first dose; 4) Whether or not they have received systemic chemotherapy or targeted therapy in the past. Cohort B: Advanced metastatic or unresectable acinar soft tissue sarcoma that has failed immunotherapy (stage IV) 1) Patients with pathologically confirmed advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) (according to the 8th edition of the American Joint Committee on Cancer [AJCC] stage); 2) Radiographically confirmed disease progression after prior treatment with anti-PD-1/PD-L1 antibodies; 3) Have not received local therapy for the tumor within 4 weeks prior to the first dose. 4) Whether or not they have received systemic chemotherapy or targeted therapy in the past. Enrollment criteria that both Cohort A and Cohort B need to meet: 1) Signed the Informed Consent Form (ICF) and are able to comply with the visits and related procedures specified in the protocol; 2) Male or female >= age 18 years; 3) Expected survival time>= 12 weeks; 4) presence of at least 1 measurable lesion according to RECIST v1.1 criteria, accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent preferred) with a length of >=10 mm (except for lymph nodes, which must be ≥15 mm in the short axis of the lymph node) at baseline, and the lesion is suitable for repeated accurate measurement; 5) Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1; 6) Adequate organ and bone marrow function (except for subjects who have used any cell and growth factor therapy, red blood cell or platelet transfusion, etc. transfusion therapy within 2 weeks prior to the first dose of study drug), defined as follows: Complete blood count: absolute neutrophil count (ANC) >= 1.5×109/L or within the normal range, platelet (PLT) count >=100×109/L, haemo-redHemoglobin (HGB) >= 9.0 g/dL; 7) Liver function: serum total bilirubin (TBIL) <=1.5× Upper limit of normal value (ULN); Alanine Aminotransferase (ALT) and aspartic acid 8) Renal function: serum creatinine (Cr) <= 1.5× ULN or clearance of creatinine (CCr) >=50mL/min, CCr calculated using the Cockcroft-Gault formula (using actual body weight); 9) urine routine: urine protein <2+; for subjects with urine protein ≥2+ on urine dipstick at baseline, 24-hour urine collection should be performed and the protein content in the urine within 24 hours should be <1g (if both tests are used, the 24-hour urine collection results will be used to determine eligibility); 10) Coagulation function: Activated partial thromboplastin time (APTT) <= 1.5× ULN and International Normalized Ratio (INR) <= 1.5. 11) Female subjects of childbearing age or male subjects whose partner is a woman of childbearing age should use effective contraception throughout the treatment period and for 180 days after the treatment period.

排除标准：

1. 既往曾暴露于LAG-3抗体类药物治疗； 2. 在研究药物首次给药之前4周之内接受过任何研究性药物治疗； 3. 在研究药物给药前28天内接受过全身化疗或靶向治疗； 4. 首次给药前2周内接受过具有抗肿瘤适应症的中草药或免疫调节作用药物（包括胸腺肽、干扰素、白介素）的系统性全身治疗； 5. 正在参与另一项干预性临床研究，或处于干预性研究的随访阶段； 6. 已知有中枢神经系统（Central Nervous System, CNS）转移和/或脊髓压迫和/或癌性脑膜炎，有软脑脊膜癌病史。对于脑转移病灶经过放疗或手术治疗后症状稳定的患者，只要符合下列所有标准，可参与本项研究：中枢神经系统之外有可测量的病灶；无中脑、脑桥、脑膜、延髓或脊髓转移；脑转移治疗后没有新的或扩大的脑转移瘤的证据，并在研究治疗之前停止了皮质类固醇和抗惊厥药物治疗至少14天则可以参加；无症状脑转移患者，需对脑转移病灶进行放疗，治疗后满足上述条件可以入选研究； 7. 在首次给药前5年内诊断为其他恶性肿瘤，下述情况除外：经过根治的皮肤基底细胞癌、皮肤鳞状细胞癌和/或经过根治切除的原位癌以及根治术后的局部前列腺癌、甲状腺乳头状癌等； 8. 预计在试验治疗期间接受其它抗肿瘤治疗； 9. 需要长期系统性激素或任何其它免疫抑制药物治疗，不包括吸入激素治疗； 10. 在研究药物首次给药之前4周之内使用过免疫抑制药物，不包括： （1） 鼻内吸入性局部类固醇治疗或局部类固醇注射（如关节腔内注射）； （2） 未超过10mg/天泼尼松或其等效生理剂量的全身皮质类固醇治疗； （3） 糖皮质激素作为过敏反应的预防用药（如CT前用药）。 11. 在研究药物首次给药之前4周之内或计划在研究期间接受减毒活疫苗接种； 12. 在研究药物首次给药之前4周之内接受过重大的外科手术（开颅、开胸或开腹手术或其它由研究者定义）或者存在未愈合的伤口、溃疡或骨折。注：以姑息治疗为目的，对于孤立病灶的局部手术治疗是可以接受的； 13. 有放射性肺炎、特发性肺炎、活动性肺炎、肺纤维化、弥漫性肺间质病或机化性肺炎（例如闭塞性细支气管炎）病史； 14. 患有活动性自身免疫性疾病或炎性疾病（包括炎症性肠病[例如结肠炎或克罗恩病]、憩室炎[憩室病除外]、乳糜泻、系统性红斑狼疮、 Sarcoidosis综合征或Wegener综合征[肉芽肿伴多血管炎]、Graves氏病、类风湿性关节炎、垂体炎、葡萄膜炎等），或既往2年内有该病病史（在近2年之内不需要系统治疗的白癜风、银屑病、脱发或格雷夫氏病，仅需要甲状腺激素替代治疗的甲状腺功能减退以及仅需要胰岛素替代治疗的1型糖尿病受试者可以入组）。已知原发性免疫缺陷病史。仅存在自身免疫性抗体阳性的患者根据研究者判断确认是否存在自身免疫性疾病； 15. 急性或者慢性活动性乙型肝炎，定义为乙型肝炎表面抗原（HBsAg）或仅乙型肝炎核心抗体（HBcAb）阳性，且乙型肝炎病毒（HBV）DNA拷贝数≥1×104拷贝数/ml或≥2000IU/ml；急性或慢性活动性丙型肝炎，定义为HCV抗体阳性且HCV RNA阳性； 16. 未能控制的并发疾病，如： （1） 开始研究治疗前4周内发生严重感染，包括但不限于因感染、菌血症或重症肺炎并发症而住院治疗；或开始研究治疗前两周内接受过治疗性口服或静脉注射抗生素； （2） HIV感染者（HIV 1/2 抗体阳性）； （3） 症状性充血性心力衰竭（纽约心脏病协会分级II~IV级）或心脏彩超检查提示LVEF（左室射血分数）<50%，或控制不佳的心律失常； （4） 先天性长QT综合征病史或筛查时校正的QTc＞500ms（使用Fridericia法计算）； （5） 心肌炎病史； （6） 即使给予规范治疗仍然未受控制的高血压（收缩压≥150mmHg或舒张压≥100mmHg）； （7） 未控制的高钙血症或症状性高钙血症（＞1.5mmol/L离子钙或钙＞12mg/dL或校正血清钙＞ULN）； （8） 需要立即干预的食管或胃底静脉曲张（例如，套扎或硬化治疗）或有门静脉高压证据根据研究者的意见或咨询胃肠病学专家或肝脏病学专家认为其出血风险较高； （9） 在入选治疗前6个月内发生过任何动脉血栓栓塞事件，包括心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作等； （10） 在入组前3个月内有深静脉血栓或其它任何严重血栓栓塞的病史（植入式静脉输液港或导管源性血栓形成，或浅表静脉血栓形成不被视为“严重”血栓栓塞）； （11） 在入选研究前3个月内发生任何危及生命的出血事件且需要医学干预治疗如：输血治疗、手术或局部治疗、持续药物等治疗； （12） 不受控制的代谢紊乱或其它非恶性肿瘤器官或全身性疾病或癌症继发反应，并可导致较高医学风险和/或生存期评价不确定性，经研究者判断不适合入组或存在经研究者判断不适合入组的其他情况； （13） 在入选研究前6个月内有胃肠道穿孔和/或瘘管的病史； （14） 有肠梗阻（除外已手术根治的肠梗阻）或肠穿孔风险的受试者（包括但不限于急性憩室炎、腹腔脓肿、腹腔癌病史）或以下疾病的病史：广泛肠切除（部分结肠切除或广泛小肠切除，并发慢性腹泻）、克罗恩氏病、溃疡性结肠炎或慢性腹泻； （15） 显著的营养不良，如需要静脉补充营养液；首剂研究治疗之前营养不良已纠正4周以上除外； （16） 肿瘤侵犯周围重要脏器或血管（如纵膈大血管、上腔静脉、气管、食管等）或存在发生食管气管瘘或食管胸膜瘘风险； （17） 食管或气管腔内支架植入术后； （18） 可能会导致以下结果的其它急性或慢性疾病或实验室检测值异常：增加研究参与或研究药物给药的相关风险，或者干扰研究结果的解读，而且根据研究者的判断将受试者列为不符合参加本研究的资格； （19） 符合以下特征的神经、精神疾病或社会状况：影响研究要求的依从性，显著增加不良事件风险，或影响受试者提供书面知情同意书的能力，例如有精神分裂症、药物滥用史等。 17. 合并活动性肺结核或活动性梅毒； 18. 已知异体器官移植史和异体造血干细胞移植史； 19. 伴有未控制的需要反复引流的第三间隙积液，如胸水、腹水、心包积液等（不需要引流积液或停止引流3天积液无明显增加的患者可以入组）； 20. 已知受试者既往对其他单克隆抗体产生过严重过敏反应，或对任何研究药物制剂过敏（包括：IBI110、信迪利单抗）； 21. 妊娠或哺乳期的女性受试者。

Exclusion criteria：

1. Previous exposure to LAG-3 antibody-based drugs; 2. Received any investigational drug within 4 weeks before the first dose of the study drug; 3. Received systemic chemotherapy or targeted therapy within 28 days before study drug administration; 4. Received systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin) with anti-tumor indications within 2 weeks before the first dose; 5. Participating in another interventional clinical study or in the follow-up stage of an interventional study; 6. Known Central Nervous System (CNS) metastasis and/or spinal cord compression and/or carcinommeningitis, with a history of leptomeningeal carcinomatosis. Patients who were symptomatic and stable after radiation or surgery for brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; There was no mesencephalon, pons, meninges, medulla oblongata or spinal cord metastasis. Participants were eligible if they had no evidence of new or expanding brain metastases after treatment for brain metastases and if they had stopped corticosteroid and anticonvulsant therapy for at least 14 days prior to study treatment; Patients with asymptomatic brain metastases who met the above conditions after treatment were eligible for inclusion in the study. 7. Other malignant tumors diagnosed within 5 years before the first dose of treatment, excluding the following: radical skin basal cell carcinoma, skin squamous cell carcinoma and/or carcinoma in situ after radical resection, local prostate cancer, papillary thyroid cancer after radical resection, etc.; 8. Is expected to receive other antineoplastic therapy during the trial treatment; 9. Need long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy; 10. Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding: (1) intranasal topical steroid therapy or local steroid injection (e.g., intra-articular injection); (2) no systemic corticosteroid therapy exceeding 10mg/ day of prednisone or its physiological equivalent; (3) glucocorticoids as a preventive drug for allergic reactions (e.g., before CT). 11. Receive live attenuated vaccine less than 4 weeks before the first dose of study drug or is planned to do so during the study; 12. Had undergone major surgical procedures (craniotomy, thoracotomy, laparotomy, or other investigator-defined) or had nonhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug. Note: For the purpose of palliative treatment, local surgery is acceptable for isolated lesions. 13. A history of radiation pneumonitis, idiopathic pneumonitis, active pneumonitis, pulmonary fibrosis, diffuse interstitial lung disease, or organizing pneumonia (e.g., bronchiolitis obliterans); 14. Have an active autoimmune or inflammatory disease (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [other than diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.), or a history of the disease within the previous 2 years (vitiligo, psoriasis, alopecia, or Graves' disease that did not require systemic treatment within the previous 2 years; Subjects with hypothyroidism requiring thyroid hormone replacement only and those with type 1 diabetes requiring insulin replacement only were eligible.) A history of primary immunodeficiency was known. For patients with only positive autoimmune antibodies, the existence of autoimmune diseases was determined according to the investigator's judgment. 15. Acute or chronic active hepatitis B, defined as hepatitis B surface antigen (HBsAg) or only hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) DNA copy number >=1×104 copies /ml or >=2000IU/ml; Acute or chronic active hepatitis C, defined as positive HCV antibody and HCV RNA; 16. Uncontrolled concurrent diseases such as: (1) serious infection within 4 weeks before starting study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; Or received therapeutic oral or intravenous antibiotics within 2 weeks before starting study treatment; (2) HIV infection (HIV 1/2 antibody positive); (3) symptomatic congestive heart failure (New York Heart Association class II-IV) or left ventricular ejection fraction (LVEF) <50% or poorly controlled arrhythmia on echocardiography; (4) history of congenital long QT syndrome or corrected QTc > 500ms (calculated with Fridericia's method); (5) history of myocarditis; (6) uncontrolled hypertension (systolic blood pressure >=150mmHg or diastolic blood pressure >=100mmHg) despite standard treatment; (7) uncontrolled hypercalcemia or symptomatic hypercalcemia (> 1.5mmol/L ionized calcium or calcium > 12mg/dL or corrected serum calcium > ULN); (8) esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy) or evidence of portal hypertension deemed to be at high risk for bleeding on the basis of the investigator's opinion or consultation with an expert gastroenterologist or hepatologist; (9) patients had any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, within 6 months before enrollment; 10) history of deep vein thrombosis or any other major thromboembolism within 3 months before enrollment (implantable access port or catheter thrombosis, or superficial venous thrombosis were not considered to be "major" thromboembolism); (11) patients who had any life-threatening bleeding event requiring medical intervention such as blood transfusion, surgery or local treatment, or continuous drug treatment within 3 months before study entry; (12) uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary effects of cancer, leading to high medical risk and/or uncertainty of survival evaluation, unsuitable for enrollment or other conditions judged by the investigator to be unsuitable for enrollment; (13) a history of gastrointestinal perforation and/or fistula within 6 months before study entry; (14) subjects at risk of intestinal obstruction (other than surgically cured intestinal obstruction) or intestinal perforation (including but not limited to a history of acute diverticulitis, abdominal abscess, abdominal cancer) or a history of wide bowel resection (partial colectomy or wide bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea; (15) significant malnutrition, if intravenous nutrient solution is required; Patients were excluded if malnutrition had been corrected for more than 4 weeks before the first dose of study treatment; (16) tumor invasion of surrounding important organs or blood vessels (such as mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or risk of esophagotracheal fistula or esophagopleural fistula; (17) after esophageal or tracheal stent implantation; (18) other acute or chronic medical conditions or abnormal laboratory values that could cause the following: increase the risk associated with study participation or administration of study drugs, or interfere with the interpretation of study results and, in the investigator's judgment, make the subject ineligible for the study; (19) a neurological, psychiatric, or social condition that affects adherence to study requirements, significantly increases the risk of adverse events, or affects the participant's ability to provide written informed consent (e.g., a history of schizophrenia or substance abuse). 17. Complicated with active tuberculosis or active syphilis; 18. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 19. Patients with uncontrolled third-space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients who do not need drainage of effusion or stop drainage for 3 days without significant increase in effusion can be enrolled); 20. The subject has a known history of anaphylaxis to other monoclonal antibodies or to any of the study drug preparations (including IBI110, sintilimab); 21. Pregnant or lactating female subjects.

研究实施时间：

Study execute time：

从 From 2022-02-21 00:00:00至 To 2024-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-07-06 00:00:00 至 To 2024-01-01 00:00:00

干预措施：

Interventions：

组别：

队列A：既往未接受过免疫治疗的晚期转移或不可切除腺泡状软组肉瘤（IV 期）

样本量：

 20

Group：

Cohort A: Advanced metastatic or unresectable acinar soft tissue sarcoma that has not received prior immunotherapy (stage IV)

Sample size：

干预措施：

A队列：给予IBI110（200 mg IV Q3W）联合信迪利单抗（200 mg IV Q3W）治疗至疾病进展、毒性不能耐受、死亡、或受试者不愿继续参加研究（以先发生者为准）。计划入组20 例受试者。

干预措施代码：

Intervention：

Cohort A: IBI110 (200 mg IV Q3W) plus sintilimab (200 mg IV Q3W) was administered until disease progression, toxicity intolerance, death, or the subject's unwillingness to continue participating in the study (whichever occurs first). It is planned to enroll 20 subjects.

Intervention code：

组别：

队列 B：免疫治疗失败的晚期转移或不可切除腺泡状软组织免疫治疗失败的晚期转移或不可切除腺泡状软组织肉瘤（IV 期）

样本量：

 10

Group：

Cohort B: advanced metastatic immunotherapy failure or unresectable acinar soft tissue sarcoma (stage IV) that has failed immunotherapy or unresectable acinar soft tissue sarcoma

Sample size：

干预措施：

B队列：给予IBI110（200 mg IV Q3W）联合信迪利单抗(200 mg IV Q3W)治疗至疾病进展、毒性不能耐受、死亡、或受试者不愿继续参加研究（以先发生者为准）。计划入组 10 例受试者。

干预措施代码：

Intervention：

Cohort B: IBI110 (200 mg IV Q3W) plus sintilimab (200 mg IV Q3W) was administered until disease progression, toxicity intolerance, death, or subject's unwillingness to continue the study (whichever occurs first). Ten subjects are planned to be enrolled.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京肿瘤医院 

单位级别：

 三甲 

Institution
hospital：

Beijing Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective response rate, ORR

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall survival, OS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疾病控制率

指标类型：

次要指标

Outcome：

Disease control rate, DCR

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

缓解持续时间

指标类型：

次要指标

Outcome：

Duration of remission, DoR

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

至缓解时间

指标类型：

次要指标

Outcome：

Time to remission, TTR

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

http://www.medresman.org.cn/login.aspx，在试验结束6个月内上传试验数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

http://www.medresman.org.cn/login.aspx, data were uploaded within 6 months after the end of the trial.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

ResMan, http://www.medresman.org.cn/login.aspx

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

ResMan, http://www.medresman.org.cn/login.aspx

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-02-27 15:48:11