ChiCTR2600122298 版本V1.0 版本创建时间2026/04/11 17:00:34 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：

ChiCTR2600122298 

最近更新日期：

Date of Last Refreshed on：

2026-04-11 17:00:24 

注册时间：

Date of Registration：

2026-04-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

阿得贝利单抗（PD-L1抑制剂）联合阿帕替尼用于既往接受过系统治疗的晚期肝细胞癌患者的有效性和安全性：一项单臂、II期临床研究

Public title：

Efficacy and safety of Adebrelimab plus Apatinib in patients with advanced hepatocellular carcinoma previously treated with systemic therapy: A single-arm, phase II study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阿得贝利单抗（PD-L1抑制剂）联合阿帕替尼用于既往接受过系统治疗的晚期肝细胞癌患者的有效性和安全性：一项单臂、II期临床研究

Scientific title：

Efficacy and safety of Adebrelimab plus Apatinib in patients with advanced hepatocellular carcinoma previously treated with systemic therapy: A single-arm, phase II study

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：

宋鹏 

研究负责人：

宋鹏 

Applicant：

Song Peng 

Study leader：

Song Peng 

申请注册联系人电话：

Applicant telephone：

+86 18888888888

研究负责人电话：

Study leader's telephone：

+86 10 12345678

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：

songpeng@cicams-sz.org.cn

研究负责人电子邮件：

Study leader's E-mail：

76743200@qq.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：

中国广东省深圳市龙岗区宝荷路113号

研究负责人通讯地址：

中国广东省深圳市龙岗区宝荷路113号

Applicant address：

113 Baohe Road, Longgang District, Shenzhen, Guangdong, China

Study leader's address：

113 Baohe Road, Longgang District, Shenzhen, Guangdong, China

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：

中国医学科学院肿瘤医院深圳医院

Applicant's institution：

Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences

研究负责人所在单位：

中国医学科学院肿瘤医院深圳医院

Affiliation of the Leader：

Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

YW2025-17-1

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：

中国医学科学院肿瘤医院深圳医院伦理委员会

Name of the ethic committee：

the Ethics Committee of Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2025-04-17 00:00:00

伦理委员会联系人：

熊露丹

Contact Name of the ethic committee：

Xiong Ludan

伦理委员会联系地址：

中国广东省深圳市龙岗区宝荷路113号

Contact Address of the ethic committee：

113 Baohe Road, Longgang District, Shenzhen, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 755 66618168

伦理委员会联系人邮箱：

Contact email of the ethic committee：

szchiec@163.com

研究实施负责（组长）单位：

中国医学科学院肿瘤医院深圳医院

Primary sponsor：

Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

中国广东省深圳市龙岗区宝荷路113号

Primary sponsor's address：

113 Baohe Road, Longgang District, Shenzhen, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中国医学科学院肿瘤医院深圳医院

具体地址：

中国广东省深圳市龙岗区宝荷路113号

Institution
hospital：

Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences

Address：

113 Baohe Road, Longgang District, Shenzhen, Guangdong, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected project (self-funded)

Target disease：

Patients with locally advanced unresectable or metastatic hepatocellular carcinoma who have progressed due to resistance after previous systemic therapy (targeted therapy with or without immunotherapy)

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：

单臂 

Study design：

Single arm 

研究目的：

主要目的：通过评估客观缓解率（ORR）评价阿得贝利单抗（PD-L1抑制剂）联合阿帕替尼用于既往接受过系统治疗的晚期肝细胞癌患者的有效性。 次要目的：通过评估疾病进展时间（TTP）、无进展生存期（PFS），疾病控制率（DCR）、缓解持续时间（DoR）和总生存期（OS）评价阿得贝利单抗（PD-L1抑制剂）联合阿帕替尼用于既往接受过系统治疗的晚期肝细胞癌患者的有效性；评价阿得贝利单抗（PD-L1抑制剂）联合阿帕替尼用于既往接受过系统治疗的晚期肝细胞癌患者的安全性。  

Objectives of Study：

Primary objective: To evaluate the efficacy of adebrelimab (a PD-L1 inhibitor) in combination with apatinib in patients with advanced hepatocellular carcinoma who have previously received systemic therapy by assessing the objective response rate (ORR). Secondary objectives: To evaluate the efficacy of adebrelimab (a PD-L1 inhibitor) in combination with apatinib in patients with advanced hepatocellular carcinoma who have previously received systemic therapy by assessing time to progression (TTP), progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), and overall survival (OS); and to evaluate the safety of adebrelimab (a PD-L1 inhibitor) in combination with apatinib in these patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 患者自愿加入本研究，签署知情同意书； 2. 年龄＞＝18周岁（以签署知情同意当日计算），男女皆可； 3. 病理或临床确诊的HCC； 4. 既往至少接受过1种及以上系统治疗（靶向伴或不伴免疫治疗）； 5. 巴塞罗那临床肝癌分期（BCLC分期）B期或C期，且不适合手术或局部治疗，或经过手术和/或局部治疗后进展； 6. 局部治疗（包括但不限于手术、放疗、肝动脉栓塞、TACE、肝动脉灌注、射频消融、冷冻消融或经皮乙醇注射）至少在基线影像学扫描前4周已完成（姑息性放疗2周即可），且局部治疗引起的毒性反应（脱发除外）必须恢复至美国国家癌症研究所-不良事件通用术语标准第5.0版（NCI-CTCAE v5.0）评级＜＝1级； 7. 基线影像学检查上有符合mRECIST标准的可测量病灶； 8. Child-Pugh肝功能分级：A级； 9. ECOG-PS评分：0-1分； 10. 预计生存期大于3个月； 11. 主要器官功能基本正常，无严重血液、心、肺、肝、肾、骨髓等功能异常和免疫缺陷疾病，符合方案要求：（1）血常规检查：（除外血红蛋白，筛查前14天内未输血、未使用粒细胞集落刺激因子[G-CSF]、7天内未使用纠正治疗） 1）血红蛋白 ＞＝ 90 g/L； 2）中性粒细胞计数 ＞＝ 1.5×10^9/L； 3）血小板计数 ＞＝ 50×10^9/L； （2）生化检查：（14天内未输白蛋白） 1）血清白蛋白 ＞＝ 29 g/L； 2）丙氨酸氨基转移酶（ALT）和天门冬氨酸氨基转移酶（AST）＜＝ 2.5倍正常值上限（ULN）； 3）总胆红素（TBIL）＜＝ 1.5倍ULN； 4）肌酐Cr ＜＝ 1.5倍ULN或Cr清除率 > 50 mL/min（Cockcroft-Gault公式如下）： 男性：Cr清除率=((140-年龄)×体重)/(72×血Cr) 女性：Cr清除率=((140-年龄)×体重)/(72×血Cr) × 0.85 体重单位：kg；血Cr单位：mg/mL； 5）尿蛋白 < 2+（若尿蛋白 ＞＝ 2+，可以进行24小时（h）尿蛋白定量，24h尿蛋白定量<1.0 g 可以入组）； （3）凝血功能：活化部分凝血活酶时间（APTT）和国际标准化比值（INR）＜＝ 1.5×ULN（对于使用稳定剂量的抗凝治疗如低分子肝素或者华法林且INR在抗凝血剂的预期治疗范围内可以筛选）； （4）促甲状腺激素（TSH）＜＝ ULN；如果异常应考察T3和T4水平，T3和T4水平正常则可以入选。 12. 若患者患有活动性乙型肝炎病毒（HBV）感染且愿意在研究期间全程接受抗病毒治疗（依据当地标准治疗进行治疗，例如恩替卡韦），在监测病毒拷贝数的情况下，由医生根据患者个体情况判断是否符合入组； 13. 丙型肝炎病毒（HCV）核糖核酸（RNA）阳性患者必须按当地标准治疗指南接受抗病毒治疗且肝功能在CTCAE 1级升高以内； 14. 有生育能力的女性：必须同意从签署知情同意书开始直到研究药物末次给药后至少120天内禁欲（避免异性性交）或使用可靠、有效方法避孕。且在开始研究治疗前的7天内血清HCG检查必须为阴性；而且必须为非哺乳期。如果女性患者已来月经、尚未达到绝经后状态（连续无月经时间>=12个月，除绝经之外未发现其他原因），且未接受过绝育手术（如子宫切除术、双侧输卵管结扎术或双侧卵巢切除术），则认为该患者有生育能力； 15. 对于伴侣为育龄妇女的男性患者，必须同意从签署知情同意书开始直到研究药物末次给药后至少120天内禁欲，或使用可靠、有效方法避孕。在同一时间段内男性受试者也必须同意不捐精子。伴侣已怀孕的男性受试者须使用避孕套，无须再采用其它避孕方法。

Inclusion criteria

1. Patients voluntarily participate in this study and sign the informed consent form; 2. Aged >= 18 years (calculated as of the date of signing the informed consent form), male or female; 3. Pathologically or clinically confirmed hepatocellular carcinoma (HCC); 4. Have previously received at least one or more lines of systemic therapy (targeted therapy with or without immunotherapy); 5. Barcelona Clinic Liver Cancer (BCLC) stage B or C, unsuitable for surgery or local treatment, or progressed after surgery and/or local treatment; 6. Local treatment (including but not limited to surgery, radiotherapy, hepatic artery embolization, transcatheter arterial chemoembolization [TACE], hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) must have been completed at least 4 weeks before the baseline imaging scan (palliative radiotherapy requires only 2 weeks), and toxic reactions caused by local treatment (except alopecia) must have recovered to <= Grade 1 according to the National Cancer Institute Cnology Criteria for Adverse Events version ommon Termi5.0 (NCI-CTCAE v5.0); 7. Presence of measurable lesions meeting the modified Response Evaluation Criteria in Solid Tumors (mRECIST) on baseline imaging; 8. Child-Pugh liver function class A; 9. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-1; 10. Expected survival time > 3 months; 11. Basic normal function of major organs, without severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases, meeting the protocol requirements: (1) Blood routine examination: (except hemoglobin; no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF] within 14 days before screening, and no corrective treatment within 7 days) 1) Hemoglobin >= 90 g/L; 2) Neutrophil count >= 1.5×10^9/L; 3) Platelet count >= 50×10^9/L; (2) Biochemical examination: (no albumin transfusion within 14 days) 1) Serum albumin >= 29 g/L; 2) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×upper limit of normal (ULN); 3) Total bilirubin (TBIL) < 1.5×ULN; 4) Creatinine (Cr) <= 1.5×ULN or creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula as follows): For males: Creatinine clearance = ((140 - age) × weight) / (72 × serum Cr) For females: Creatinine clearance = ((140 - age) × weight) / (72 × serum Cr) × 0.85 (Weight unit: kg; Serum Cr unit: mg/mL) 5) Urinary protein < 2+; if urinary protein >= 2+, a 24-hour urinary protein quantification can be performed, and patients with 24-hour urinary protein quantification < 1.0 g are eligible for enrollment; (3) Coagulation function: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5×ULN (patients receiving stable-dose anticoagulant therapy such as low-molecular-weight heparin or warfarin with INR within the expected therapeutic range of anticoagulants can be screened); (4) Thyroid-stimulating hormone (TSH) <= ULN; if abnormal, triiodothyronine (T3) and thyroxine (T4) levels should be examined, and patients with normal T3 and T4 levels are eligible; 12. Patients with active hepatitis B virus (HBV) infection who are willing to receive full-course antiviral therapy during the study (according to local standard treatment, such as entecavir) may be eligible for enrollment based on the doctor's judgment of individual patient conditions under viral load monitoring; 13. Patients with positive hepatitis C virus (HCV) ribonucleic acid (RNA) must receive antiviral therapy according to local standard treatment guidelines, and liver function elevation must be within CTCAE Grade 1; 14. Female patients of childbearing potential: Must agree to abstain from heterosexual intercourse or use reliable and effective contraception from the signing of the informed consent form until at least 120 days after the last dose of the study drug. Additionally, serum human chorionic gonadotropin (HCG) must be negative within 7 days before the start of study treatment; and must be non-lactating. A female patient is considered to have childbearing potential if she has menstruated, has not reached postmenopausal status (amenorrhea for >= 12 consecutive months with no other identified causes except menopause), and has not undergone sterilization (such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy); 15. Male patients whose partners are women of childbearing potential must agree to abstain from heterosexual intercourse or use reliable and effective contraception from the signing of the informed consent form until at least 120 days after the last dose of the study drug. Male subjects must also agree not to donate sperm during the same period. Male subjects whose partners are pregnant must use condoms and do not need to adopt other contraceptive methods.

排除标准：

1. 既往接受过PD-L1免疫治疗或者阿帕替尼靶向药物治疗；
2. 血管造影无法找到明确的肿瘤供血动脉；
3. 已知肝胆管细胞癌、肉瘤样HCC、混合细胞癌及纤维板层细胞癌；5年内或同时患有除HCC之外的其它活动性恶性肿瘤。已治愈的局限性肿瘤，如皮肤基底细胞癌、皮肤鳞癌、表浅膀胱癌、前列腺原位癌、宫颈原位癌、乳腺原位癌等可以入组；
4. 对试验药物过敏；
5. 合并其他恶性肿瘤，但以下情况除外：采用治愈性治疗的恶性肿瘤、首次研究干预前＞＝5年内已知无活动性疾病且潜在复发风险低；皮肤基底细胞癌、皮肤鳞状细胞癌或已接受潜在根治性治疗的恶性雀斑样痣；或已接受充分治疗且无疾病证据的原位癌；
6. 有肝性脑病病史者；
7. 在开始研究治疗之前28天或5个半衰期（以时间长者为准）内接受过其他试验用药物治疗；
8. 合并重症感染；
9. 由研究者判定的任何疾病证据（如严重或未受控制的全身性疾病，包括未受控制的高血压、活动性出血性疾病、活动性感染、活动性ILD/肺部炎症、与腹泻相关的严重慢性胃肠道疾病、精神疾病/社会状况）或研究者认为受试者不适于参与研究或影响对研究方案的依从性的异体器官移植史；
10. 活动性或既往记录的自体免疫性或炎症性疾病（包括炎症性肠病[如，结肠炎或克罗恩病]、憩室炎[憩室病除外]、系统性红斑狼疮、肉状瘤病综合征、Wegener综合征[肉芽肿伴多血管炎]、Graves病、类风湿性关节炎、垂体炎和葡萄膜炎等）；
11. 已知HIV检测阳性（阳性HIV 1/2抗体）或活动性结核感染（临床评估可能包括临床病史、体格检查和影像学结果，或根据当地实践进行结核检测）。

Exclusion criteria：

1. Previously received PD-L1 immunotherapy or apatinib targeted therapy;
2. No clear tumor-feeding artery identifiable by angiography;
3. Known cholangiocellular carcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; having other active malignant tumors (except HCC) within 5 years or concurrently. Locally cured tumors such as basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast are eligible for enrollment;
4. Allergic to the investigational drugs;
5. Complicated with other malignant tumors, except for the following cases: malignant tumors treated with curative therapy, with no known active disease for ＞＝ 5 years before the first study intervention and low potential risk of recurrence; basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, or lentigo maligna with potentially radical treatment; or carcinoma in situ with adequate treatment and no evidence of disease;
6. A history of hepatic encephalopathy;
7. Received other investigational drug treatments within 28 days or 5 half-lives (whichever is longer) before the start of study treatment;
8. Complicated with severe infection;
9. Any evidence of disease as judged by the investigator (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, active hemorrhagic diseases, active infections, active interstitial lung disease/pulmonary inflammation, severe chronic gastrointestinal diseases related to diarrhea, mental illness/social conditions) or a history of allogeneic organ transplantation that the investigator considers makes the subject unfit to participate in the study or affects compliance with the study protocol;
10. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel diseases [e.g., colitis or Crohn's disease], diverticulitis [excluding diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc.);
11. Known positive HIV test (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical assessment may include clinical history, physical examination, and imaging findings, or tuberculosis testing according to local practices).

研究实施时间：

Study execute time：

从 From 2025-12-30 00:00:00至 To 2028-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-30 00:00:00 至 To 2027-03-31 00:00:00  

干预措施：

Interventions：

组别：

单臂研究

样本量：

47

Group：

Single-Arm Study

Sample size：

干预措施：

阿得贝利单抗 1200mg 静脉滴注 (每周1次, Q3W) 联合 阿帕替尼 250mg 口服 (每日1次, QD)

干预措施代码：

Intervention：

Atezolizumab 1200mg intravenous infusion once every 3 weeks (Q3W) combined with Apatinib 250mg oral administration once daily (QD)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中国医学科学院肿瘤医院深圳医院 

单位级别：

三级甲等 

Institution
hospital：

Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

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：

治疗期内每2个疗程（6 ~ 8周）进行一次

测量方法：

即研究者依据RECIST v1.1、mRECIST或imRECIST确定的完全缓解、部分缓解或大于等于8周的疾病稳定（SD）的受试者所占的百分比例（imRECIST标准下的CR，PR，SD可以在影像学疾病进展之后再发生）。

Measure time point of outcome：

Once every 2 courses of treatment (6–8 weeks) during the treatment period

Measure method：

That is, the percentage of subjects who achieve complete response, partial response, or stable disease (SD) lasting for >=8 weeks as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST (CR, PR, and SD under the imRECIST criteria may occur after radiological disease progression).

指标中文名：

安全性

指标类型：

次要指标

Outcome：

Safety

Type：

Secondary indicator

测量时间点：

从受试者签署知情同意书开始，直至安全性随访期结束（末次用药后30天）或开始新的抗肿瘤药物。

测量方法：

不良事件（AE）是指受试者接受试验用药品后出现的所有不良医学事件，可以表现为症状、体征、疾病或者实验室检查异常，但不一定与试验用药品有因果关系。AE信息的收集从受试者签署知情同意书开始，直至安全性随访期结束（末次用药后30天）或开始新的抗肿瘤药物。

Measure time point of outcome：

It starts from the time when the subject signs the informed consent form until the end of the safety

Measure method：

investigational product, which may present as symptoms, signs, diseases, or abnormal laboratory findings, and does not necessarily have a causal relationship with the investigational product. The collection of AE information starts from the time when the subject signs the informed consent form until the end of the safety follow-up period (30 days after the last dose) or the initiation of a new anti-tumor drug.

指标中文名：

无进展生存期

指标类型：

次要指标

Outcome：

Progression-Free Survival (PFS)

Type：

Secondary indicator

测量时间点：

治疗期内每2个疗程（6 ~ 8周）进行一次

测量方法：

指从首次出现影像学疾病进展或死亡（以先发生者为准）之间的时间，由研究者依据RECIST v1.1、mRECIST或imRECIST确定（imRECIST标准下出现的影像学疾病进展，若在>=4周后评价为缓解或稳定，此次进展不作为PFS事件）。

Measure time point of outcome：

Once every 2 courses of treatment (6–8 weeks) during the treatment period

Measure method：

It refers to the time from the first occurrence of radiological disease progression or death (whichever comes first), as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST (for radiological disease progression identified under the imRECIST criteria, if it is evaluated as response or stable disease after >=4 weeks, this progression will not be considered a PFS event).

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：

治疗期内每2个疗程（6 ~ 8周）进行一次

测量方法：

随机入组治疗至受试者因任何原因死亡的时间

Measure time point of outcome：

Once every 2 courses of treatment (6–8 weeks) during the treatment period

Measure method：

time from treatment to death

指标中文名：

疾病客观缓解率

指标类型：

主要指标

Outcome：

Objective Response Rate(ORR)

Type：

Primary indicator

测量时间点：

治疗期内每2个疗程（6 ~ 8周）进行一次

测量方法：

胸部、腹部和盆腔增强CT或增强MRI扫描

Measure time point of outcome：

Once every 2 courses of treatment (6–8 weeks) during the treatment period

Measure method：

Contrast-enhanced CT or contrast-enhanced MRI scans of the chest, abdomen, and pelvis

指标中文名：

疾病进展时间

指标类型：

次要指标

Outcome：

Time to Progression (TTP)

Type：

Secondary indicator

测量时间点：

治疗期内每2个疗程（6 ~ 8周）进行一次

测量方法：

指从接受治疗日期至发生影像学疾病进展的时间，由研究者依据RECIST v1.1、mRECIST或imRECIST确定（imRECIST标准下出现的影像学疾病进展，若>=4周后评价为缓解或稳定，此次进展不作为TTP事件）。

Measure time point of outcome：

Once every 2 courses of treatment (6–8 weeks) during the treatment period

Measure method：

It refers to the time from the date of receiving treatment to the occurrence of radiological disease progression, as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST (for radiological disease progression identified under the imRECIST criteria, if it is evaluated as response or stable disease after >=4 weeks, this progression will not be considered a TTP event).

指标中文名：

缓解持续时间

指标类型：

次要指标

Outcome：

Duration of Response (DOR)

Type：

Secondary indicator

测量时间点：

治疗期内每2个疗程（6 ~ 8周）进行一次

测量方法：

指从首次记录到客观缓解（CR或PR）至首次出现影像学疾病进展或死亡（以先发生者为准）之间的时间，由研究者依据RECIST v1.1、mRECIST或imRECIST确定（imRECIST标准下的影像学疾病进展，若在>=4周后评估为缓解或稳定，不作为DoR计算的进展事件）。

Measure time point of outcome：

Once every 2 courses of treatment (6–8 weeks) during the treatment period

Measure method：

It refers to the time from the first documentation of objective response (CR or PR) to the first occurrence of radiological disease progression or death (whichever comes first), as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST (for radiological disease progression identified under the imRECIST criteria, if it is evaluated as response or stable disease after >=4 weeks, this progression will not be considered a progression event for DoR calculation).

指标中文名：

最佳缓解(BOR)

指标类型：

次要指标

Outcome：

Best Overall Response

Type：

Secondary indicator

测量时间点：

治疗期内每2个疗程（6 ~ 8周）进行一次

测量方法：

从随机日期开始至客观记录的进展日期或后续抗肿瘤治疗日期(以先发生者为准)之间的最佳缓解指标，对于没有记录进展或后续抗肿瘤治疗的受试者，将根据所有的缓解评定结果确定BOR(imRECIST标准下为从随机日期开始至后续抗肿瘤治疗日期之间或者整个研究治疗期间的最佳缓解指标)

Measure time point of outcome：

Once every 2 courses of treatment (6–8 weeks) during the treatment period

Measure method：

The Best Overall Response (BOR) is defined as the best response observed from the date of randomization until the date of objectively documented progression or the date of subsequent anti-tumor therapy, whichever occurs first. For subjects with no documented progression or subsequent anti-tumor therapy, BOR will be determined based on all response assessment results (under imRECIST criteria, BOR is defined as the best response observed from the date of randomization until the date of subsequent

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

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

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

研究结束后半年；Resman（http://www.medresman.org.cn/）

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

Half a year after the conclusion of the research; Resman (http://www.medresman.org.cn/)

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：

病例记录表(CRF)

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

Case Report Form (CRF)

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-11 17:00:24