ChiCTR2500110280 版本V1.0 版本创建时间2025/10/11 12:14:05 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：

ChiCTR2500110280 

最近更新日期：

Date of Last Refreshed on：

2025-10-11 12:13:57 

注册时间：

Date of Registration：

2025-10-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

卡度尼利单抗联合HAIC和SBRT治疗不可切除 HCC 的有效性和安全性前瞻性单臂单中心探索性研究

Public title：

A prospective single-arm, single-center exploratory study on the efficacy and safety of cardonilimab combined with HAIC and SBRT in the treatment of unresectable HCC

注册题目简写：

English Acronym：

研究课题的正式科学名称：

卡度尼利单抗联合HAIC和SBRT治疗不可切除 HCC 的有效性和安全性前瞻性单臂单中心探索性研究

Scientific title：

A prospective single-arm, single-center exploratory study on the efficacy and safety of cardonilimab combined with HAIC and SBRT in the treatment of unresectable HCC

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：

刘苏来 

研究负责人：

刘苏来 

Applicant：

Liu Sulai 

Study leader：

Liu Sulai 

申请注册联系人电话：

Applicant telephone：

+86 152 0085 0489

研究负责人电话：

Study leader's telephone：

+86 731 8392 9085

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：

liusulai@hunnu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

liusulai-727@163.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：

湖南省长沙市解放西路61号

研究负责人通讯地址：

湖南省长沙市解放西路61号

Applicant address：

No. 61, Jiefang West Road, Furong District, Changsha City, Hunan Province

Study leader's address：

No. 61, Jiefang West Road, Furong District, Changsha City, Hunan Province

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：

湖南省人民医院（湖南师范大学附属第一医院）

Applicant's institution：

Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

研究负责人所在单位：

湖南省人民医院

Affiliation of the Leader：

Hunan Provincial People's Hospital

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：

[2024]-402

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：

湖南省人民医院（湖南师范大学附属第一医院）医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Committee of Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

伦理委员会批准日期：

Date of approved by ethic committee：

2024-11-14 00:00:00

伦理委员会联系人：

李璟

Contact Name of the ethic committee：

Li Jing

伦理委员会联系地址：

湖南省长沙市解放西路61号

Contact Address of the ethic committee：

61,Jiefang Road, Changsha, Hunan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 731 8392 9085

伦理委员会联系人邮箱：

Contact email of the ethic committee：

340011413@qq.com

研究实施负责（组长）单位：

湖南省人民医院

Primary sponsor：

Hunan Provincial People's Hospital

研究实施负责（组长）单位地址：

湖南省长沙市解放西路61号

Primary sponsor's address：

61,Jiefang Road, Changsha, Hunan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

Country：

China

Province：

Hunan

City：

单位(医院)：

湖南省人民医院

具体地址：

湖南省长沙市解放西路61号

Institution
hospital：

Hunan Provincial People's Hospital

Address：

61,Jiefang Road, Changsha, Hunan

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-raised funds

Target disease：

Unresectable hepatocellular carcinoma judged by the AASLD-2010 practice guideline standard

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

本研究是卡度尼利单抗联合HAIC和SBRT治疗不可切除HCC的有效性和安全性，具有前瞻性单臂单中心探索性研究。本研究计划入组约 30例 受试者，接受卡度尼利单抗注射液（10 mg/kg IV Q3W）+ HAIC+SBRT联合治疗直至疾病进展（根据RECIST v1.1评估）、出现无法耐受的毒性、研究者判断受试者无法继续获益、开始新的抗肿瘤治疗、受试者撤回知情同意、失访、死亡以先发生者为准。  

Objectives of Study：

This study is a prospective, single-arm, single-center exploratory study on the efficacy and safety of cardonilimab combined with HAIC and SBRT in the treatment of unresectable HCC. This study plans to enroll approximately 30 subjects. Received combined treatment of cadonilimab injection (10 mg/kg IV Q3W) + HAIC+SBRT until disease progression (according to RECIST. (v1.1 Assessment), intolerable toxicity occurs, the researcher determines that the subject can no longer benefit, new anti-tumor treatment is initiated, the subject withdraws informed consent, loss to follow-up, and death is determined by the first occurrence.

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.在任何试验相关流程实施之前，签署书面知情同意；
2.男或女性≥18周岁，≤75岁；
3.ECOG PS 评分为0-1；
4.经AASLD-2010 实践指南标准判断的不可切除HCC；
5.BCLC B/C期;无肝外转移；
6.VP1-VP3；
7.既往未接受HCC肿瘤全身或免疫治疗，TACE/HAIC 及放疗；
8.至少有一个RECIST 1.1 标准可测量病灶;肿瘤≥5cm;卫星灶（局限于一个肝叶/多于1个 肝叶≤3）；
9.肝功能Child-Pugh分级A-B7级；
10.血液、肝、肾功能满足相应条件；
11.预期生存时间>3个月；
12.总三碘甲腺原氨酸（T3）或游离T3和游离甲状腺素（T4）在正常范围内。（可以接受通过 甲状腺替代疗法控制）。无症状的T3，游离T3或游离T4异常的受试者可以入选；
13.具有充分的器官和骨髓功能，随机分组前 7 天内实验室检查值符合下列要求(获得实验室 检查的前14天内不允许通过给予任何血液成分、细胞生长因子、白蛋白及其他纠正治疗的 药物来满足条件)，具体如下：血常规：绝对中性粒细胞计数（absolute neutrophil count, ANC）≥1.5×109/L； 血小 板计数（platelet, PLT）≥75×10 9/L； 血红蛋白含量（hemoglobin, HGB）≥9.0 g/dL；肝功能：血清总胆红素（total bilirubin, TBIL）≤3×正常上限（upper limit of normal value, ULN）；丙氨酸氨基转移酶（alanine aminotransferase, ALT）、天门冬氨酸氨基 转移酶（aspartate transferase, AST）和碱性磷酸酶（alkaline phosphatase, ALP）≤ 5×ULN； 血清白蛋白≥28 g/L；肾功能：血清肌酐（creatinine, Cr）≤ 1.5×ULN 或肌酐清除率（clearance of creatinine, CCr）≥ 50mL/min（Cockcroft-Gault 公式）；尿常规结果显示尿蛋白<2+； 对基线时尿常规检测显示尿蛋白≥2+的患者，应进行24小时尿液采集且24小时尿蛋白定 量<1g； 凝血功能：国际标准化比率（international normalized ratio，INR）和活化部分凝血活 酶时间（activated partial thromboplastin time ，APTT）≤ 1.5 倍 ULN；
14.对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接 受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血 液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术；如存在 受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后 120 天（或末次化疗药物给药后180天）内采用年失败率低于1%的避孕措施。率低于1%的避孕 措施。

Inclusion criteria

1.Sign a written informed consent before the implementation of any trial-related procedures; 2.Male or female: >= 18 years old, <= 75 years old; 3.The ECOG PS score is 0-1; 4.Unresectable HCC as judged by the AASLD-2010 practice guideline standard; 5.BCLC stage B/C There is no extrahepatic metastasis; 6.VP1-VP3; 7.No previous systemic or immunotherapy, TACE/HAIC or radiotherapy for HCC tumors has been received; 8.At least one RECIST 1.1 standard can measure the lesion; The tumor is >= 5cm; Satellite foci (limited to one liver lobe/more than one liver lobe <= 3); 9.The Child-Pugh classification of liver function is grade A-B7; 10.The blood, liver and kidney functions meet the corresponding conditions; 11.Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within the normal range. It can be controlled through thyroid replacement therapy. Asymptomatic T3, subjects with abnormal free T3 or free T4 can be enrolled; 12.Have sufficient organ and bone marrow functions, and the laboratory test values within 7 days before randomization meet the following requirements (no conditions can be met by administering any blood components, cell growth factors, albumin or other corrective treatment drugs within 14 days before obtaining the laboratory test), as follows: Blood routine: The absolute neutrophil count (ANC) is >= 1.5×10^9/L; platelet count (PLT) >= 75× 10^9 /L; The hemoglobin content (HGB) is >= 9.0 g/dL; Liver function: Serum total bilirubin (TBIL) <= 3× upper limit of normal value (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ALP <= 5×ULN; Serum albumin >= 28 g/L; Renal function: Serum creatinine (Cr) <= 1.5×ULN or clearance of creatinine (CCr) >= 50mL/min (Cockcroft-Gault formula); The results of the urine routine test show that urine protein 2+ For patients whose urine routine test at baseline showed urine protein >= 2+, 24-hour urine collection and 24-hour urine protein quantification should be performed. 1g; Coagulation function: The international normalized ratio (INR) and the activated partial thromboplastin time (APTT) are <= 1.5 times ULN; 13.For female subjects of childbearing age, a urine or serum pregnancy test should be received within 3 days before the first administration of the study drug (Day 1 of Cycle 1), and the result should be negative. If the result of the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age are defined as those who have been menopausal for at least one year, or have undergone surgical sterilization or hysterectomy. If there is a risk of conception, all subjects (whether male or female) are required to adopt contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the administration of the last study drug (or 180 days after the administration of the last chemotherapy drug). Contraceptive measures with a rate lower than 1%.

排除标准：

1.既往经组织学/细胞学确诊的含纤维板层肝细胞癌、肉瘤样肝细胞癌、胆管癌等成分；
2.有肝性脑病病史，或有肝移植病史；
3.有临床症状需要引流的胸水、腹水、心包积液；
4.急性或者慢性活动性乙型肝炎或丙型肝炎感染者，乙型肝炎病毒（HBV） DNA＞ 2000IU/ml 或 104 拷贝/ml；丙型肝炎病毒（HCV）RNA＞103 拷贝/ml；乙肝表面抗原 （HbsAg）与抗HCV抗体同时阳性；
5.有中枢神经系统转移；
6.既往6个月内出现过门静脉高压导致的食管或胃底静脉曲张出血事件；
7.既往 3 个月内发生任何危及生命的出血事件，包括需要输血治疗、手术或局部治疗、持续药物治疗；
8.既往6个月内动、静脉血栓栓塞事件，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、肺动脉栓塞、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，经过常规抗凝治疗后血 栓稳定者除外。允许预防性使用小剂量低分子肝素（如依诺肝素40 mg/天）；
9.门静脉分支，或同时累及肠系膜上静脉。下腔静脉癌栓；
10.首次给药前2周内，连续10天使用阿司匹林（＞ 325 mg/天）或其他已知可以抑制血 小板功能的药物如双嘧达莫或氯吡格雷等；
11.不可控制的高血压, 经最佳医学治疗后收缩压＞150mmHg或舒张压＞90 mmHg，高血压 危象或高血压脑病病史；
12.症状性充血性心力衰竭（纽约心脏病协会分级II-IV级）。症状性或控制不佳的心律 失常。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）；
13.严重出血倾向或凝血功能障碍，或正在接受溶栓治疗；
14.既往6个月内有胃肠道穿孔和/或瘘管病史，肠梗阻病史（包括需要肠外营养的不完全 肠梗阻），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、溃疡性结肠炎或长期慢性腹泻；
15.首次给药前3周内接受过放射治疗。对于首次给药前3周前接受放射治疗的患者，必 须满足下述所有条件方可入组：目前不存在任何放疗相关的毒性反应，不需要服用糖 皮质激素，排除放射性肺炎、放射性肝炎、放射性肠炎等；
16.既往和目前有肺纤维化史、间质性肺炎、尘肺、药物相关肺炎、肺功能严重受损等肺 部疾病；
17.活动性肺结核(TB)，正在接受抗结核治疗或者首次给药前1年内接受过抗结核治疗者；
18.人免疫缺陷病毒（HIV）感染者（HIV 1/2抗体阳性），已知的梅毒感染者；
19.处于活动期或临床控制不佳的严重感染。在首次给药前4周内有重度感染，包括但不 限于因感染、菌血症或重度肺炎并发症而住院治疗；
20.首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、皮质类固醇或免 疫抑制剂）的活动性自身性免疫疾病。允许使用替代疗法（例如甲状腺素、胰岛素或 者用于肾上腺或垂体机能不全的生理性皮质类固醇等）。已知的原发性免疫缺陷病史。仅存在自身免疫抗体阳性的患者需根据研究者判断确认是否存在自身免疫性疾病；
21.首次给药前4周之内使用过免疫抑制药物，不包括喷鼻、吸入性或其他途径的局部糖 皮质激素或生理剂量的系统性糖皮质激素（即不超过 10mg/天泼尼松或等效剂量的其 他糖皮质激素）、允许因治疗哮喘、慢性阻塞性肺疾病等疾病的呼吸困难症状临时使 用糖皮质激素；
22.首次给药前4周之内或计划在研究期间接受减毒活疫苗；
23.首次给药前4周之内接受过重大的外科手术（开颅、开胸或开腹手术）或者未愈合的 伤口、溃疡或骨折。首次给药之前7天内接受过组织穿刺活检或其他小外科手术，以 静脉输液为目的的静脉穿刺置管除外；
24.首次给药前4周之内接受过针对肝癌的局部治疗；
25.首次给药前2周内接受过具有抗肿瘤适应症的中药，或接受过具有免疫调节作用的药 物（包括胸腺肽、干扰素、白介素，除外为控制胸水或腹水局部使用）；
26.不受控制/无法纠正的代谢紊乱或其它非恶性肿瘤器官疾病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；
27.在首次给药前5年内诊断为其他恶性肿瘤，不包括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。如果给药前 5 年以上诊断为其他恶性肿瘤 或肝癌，需对复发转移病灶进行病理学或细胞学诊断；
28.既往接受过任何抗PD-1抗体、抗PD-L1/L2 抗体、抗 CTLA4 抗体，或其他免疫治疗。 既往接受过抗VEGF和/或VEGFR、RAF、MEK、PDGFR、FGFR等信号通路的靶向治疗；
29.已知对于任何卡度尼利单抗、仑伐替尼制剂成分过敏；或既往对其他单克隆抗体或酪 氨酸激酶抑制剂产生过严重过敏反应；
30.首次给药前4周内接受过其他临床试验的治疗；
31.妊娠或哺乳的女性患者；
32.既往有放疗史，且既往放疗后残留病灶与此次放疗位置重合；
33.患者无法平卧，或无法配合放疗平躺10-20分钟；
34.可能会导致以下结果的其它急性或慢性疾病、精神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 断将患者列为不符合参加本研究的资格；

Exclusion criteria：

1.Previously confirmed histological/cytological components containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc;
2.There is a history of hepatic encephalopathy or liver transplantation;
3.Pleural effusion, ascites and pericardial effusion with clinical symptoms that require drainage;
4.Patients with acute or chronic active hepatitis B or C, hepatitis B virus (HBV) DNA >2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA > 103 copies /ml; Hepatitis B surface antigen Both HbsAg and anti-HCV antibodies are positive simultaneously;
5.There is metastasis in the central nervous system;
6.There has been an event of esophageal or gastric fundus variceal bleeding caused by portal hypertension within the past 6 months.
7.Any life-threatening bleeding events that occurred within the past 3 months, including those requiring blood transfusion treatment, surgery or local treatment, or continuous medication;
8.Thromboembolic events of arteries and veins within the past 6 months, including myocardial infarction, unstable angina pectoris, and cerebrovascular accident Or a history of transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other severe thromboembolism. plant Venous port or catheter-derived thrombosis, or superficial venous thrombosis, after conventional anticoagulant therapyExcept for those with stable plugs. Prophylactic use of small doses of low-molecular-weight heparin (such as enoxaparin 40 mg/ day) is permitted.
9.Branches of the portal vein, or simultaneous involvement of the superior mesenteric vein. Inferior vena cava tumor thrombus;
10.Within 2 weeks before the first administration, use aspirin (> 325 mg/ day) or other known drugs that can inhibit blood for 10 consecutive days Drugs with small plate functions such as dipyridamole or clopidogrel, etc;
11.Uncontrolled hypertension, with a systolic blood pressure greater than 150mmHg or a diastolic blood pressure greater than 90 mmHg after the best medical treatment, is considered hypertension History of crisis or hypertensive encephalopathy;
12.Symptomatic congestive heart failure (New York Heart Association Classification II-IV). Symptomatic or poorly controlled heart rhythm Abnormal. A history of congenital long QT syndrome or corrected QTc > 500ms during screening (measured using the Fridericia method) Calculate;
13.Severe bleeding tendency or coagulation dysfunction, or currently undergoing thrombolytic therapy;
14.A history of gastrointestinal perforation and/or fistula within the past 6 months, and a history of intestinal obstruction (including incomplete parenteral nutrition required)Intestinal obstruction, extensive intestinal resection (partial colectomy or extensive small intestinal resection with chronic diarrhea), Crohn's diseaseIllness, ulcerative colitis or long-term chronic diarrhea;
15.Received radiotherapy within 3 weeks before the first administration. For patients who received radiotherapy three weeks before the first administration, it is necessaryAll of the following conditions must be met to be included in the group: There are no radiotherapy-related toxic reactions at present, and no sugar intake is required Corticosteroids are used to rule out radiation pneumonitis, radiation hepatitis, radiation enteritis, etc;
16.Those with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function, etc. in the past or present Some diseases;
17.Active pulmonary tuberculosis (TB), those who are currently undergoing anti-tuberculosis treatment or have received anti-tuberculosis treatment within one year prior to the first administration of medication;
18.Human immunodeficiency virus (HIV) infected individuals (HIV 1/2 antibody positive), known syphilis infected individuals;
19.Severe infections in the active stage or with poor clinical control. Severe infection within 4 weeks before the first administration, including but not Limited to hospitalization due to infection, bacteremia or complications of severe pneumonia;
20.There was a need for systemic treatment (such as the use of disease-relieving drugs, corticosteroids or antibiotics) within 2 years prior to the first administration Active autoimmune diseases caused by epidemic inhibitors. Alternative therapies (such as thyroxine, insulin or) are allowed It is a physiological corticosteroid used for adrenal or pituitary insufficiency, etc. A known history of primary immunodeficiency.Patients with only positive autoimmune antibodies need to be confirmed for the presence of autoimmune diseases based on the researcher's judgment;
21.Immunosuppressive drugs have been used within 4 weeks before the first administration, excluding nasal spray, inhalation or other routes of topical sugar Corticosteroids or systemic glucocorticoids at physiological doses (i.e., no more than 10mg/ day prednisone or equivalent doses He is a glucocorticoid and is allowed to be used temporarily for the treatment of dyspnea symptoms in diseases such as asthma and chronic obstructive pulmonary disease Use glucocorticoids;
22.Attenuated live vaccines should be received within 4 weeks before the first administration or during the planned study period;
23.Those who have undergone major surgical operations (craniotomy, thoracotomy or laparotomy) or have not healed within 4 weeks before the first administration Wounds, ulcers or fractures. A tissue biopsy or other minor surgical operation was performed within 7 days before the first administration Venous puncture and catheterization for the purpose of intravenous infusion are excluded;
24.Local treatment for liver cancer was received within 4 weeks before the first administration;
25.Have received traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects within two weeks before the first administration Substances (including thymosin, interferon, interleukin, except for local use to control pleural effusion or ascites);
26.Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary cancers The reaction can lead to a higher medical risk and/or uncertainty in survival assessment;
27.Other malignant tumors were diagnosed within 5 years prior to the first administration, excluding radical basal cell carcinoma of the skin and skin Squamous cell carcinoma and/or carcinoma in situ after radical resection. If other malignant tumors were diagnosed more than 5 years before administration For liver cancer, pathological or cytological diagnosis of recurrent and metastatic lesions is required;
28.Has received any anti-PD-1 antibody, anti-PD-L1 /L2 antibody, anti-CTLA4 antibody, or other immunotherapy in the past.Previously received targeted therapy for anti-VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR and other signaling pathways;
29.It is known that there is an allergy to any ingredients of cadonilimab or lenvatinib preparations; Or previously against other monoclonal antibodies or tyrosineSevere allergic reactions have occurred with amino acid kinase inhibitors;
30.Received treatment from other clinical trials within 4 weeks before the first administration;
31.Female patients who are pregnant or breastfeeding;
32.There is a history of radiotherapy in the past, and the residual lesion after previous radiotherapy coincides with the location of this radiotherapy.
33.Other acute or chronic diseases, mental disorders or abnormal laboratory test values that may lead to the following results: Increased research To investigate the risks related to drug administration or interfere with the interpretation of research results, and based on the judgment of the researcher The patient was not classified as ineligible to participate in this study;

研究实施时间：

Study execute time：

从 From 2024-11-14 00:00:00至 To 2027-11-14 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-06-01 00:00:00 至 To 2026-11-14 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

30

Group：

Experimental group

Sample size：

干预措施：

卡度尼利单抗联合HAIC和SBRT

干预措施代码：

Intervention：

Cadonilimab combined with HAIC and SBRT

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

  

Country：

China 

Province：

Hunan 

City：

 

单位(医院)：

湖南省人民医院 

单位级别：

三级甲等 

Institution
hospital：

Hunan Provincial People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

≥50%肿瘤坏死率

指标类型：

次要指标

Outcome：

The tumor necrosis rate is >= 50%

Type：

Secondary indicator

测量时间点：

手术切除后病理报告时间

测量方法：

受试者病历

Measure time point of outcome：

The time of pathological report after surgical resection

Measure method：

Medical records of the subjects

指标中文名：

手术转化率

指标类型：

次要指标

Outcome：

Surgical conversion rate

Type：

Secondary indicator

测量时间点：

每90天

测量方法：

受试者病历

Measure time point of outcome：

Every 90 days

Measure method：

Medical records of the subjects

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

Objective response rate

Type：

Primary indicator

测量时间点：

每90天

测量方法：

肿瘤影像学评估

Measure time point of outcome：

Every 90 days

Measure method：

Tumor imaging assessment

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall survival

Type：

Secondary indicator

测量时间点：

每90天

测量方法：

随访、受试者病历

Measure time point of outcome：

Every 90 days

Measure method：

Follow-up, subjects' medical records

指标中文名：

病理完全缓解率

指标类型：

次要指标

Outcome：

Pathological complete response rate

Type：

Secondary indicator

测量时间点：

每90天

测量方法：

受试者病历

Measure time point of outcome：

Every 90 days

Measure method：

Medical records of the subjects

指标中文名：

无疾病进展时间

指标类型：

次要指标

Outcome：

Progression-Free Survival

Type：

Secondary indicator

测量时间点：

每90天

测量方法：

肿瘤影像学评估

Measure time point of outcome：

Every 90 days

Measure method：

Tumor imaging assessment

指标中文名：

疾病进展时间

指标类型：

次要指标

Outcome：

Time to Progression

Type：

Secondary indicator

测量时间点：

每90天

测量方法：

肿瘤影像学评估

Measure time point of outcome：

Every 90 days

Measure method：

Tumor imaging assessment

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

Adverse events

Type：

Secondary indicator

测量时间点：

自签署知情同意书起到最后一次给药后30天内

测量方法：

询问受试者非诱导性问题

Measure time point of outcome：

Within 30 days from the signing of the informed consent form to the last administration

Measure method：

Ask the subjects non-inducible questions

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

肿瘤组织样本

组织：

Sample Name：

Tumor tissue sample

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

全血

组织：

Sample Name：

Whole blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

共享原始数据方式：国家生物信息中心 China National center for Bioinformation (htp://ngdc.cncb.ac.cn/gsub/) 共享原始数据日期：2028-11-14

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

National biological information center, China National center for Bioinformation (HTP: / / NGDC. CNCB. Ac. Cn/gsub /)

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：

临床试验中的文件（方案和方案修订，完成的 CRF，签署的 ICF 等）需按照GCP 的要求进行保存和管理。研究中心应将这些文件保存到研究结束后 5 年。 研究文件应合理保存，以便日后访问或数据溯源。保存文件时应考虑安全及环境风险问题。 研究者同意相关监管部门直接访问所有研究相关文件，包括受试者病历。

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

Documents in clinical trials (protocols and protocol revisions, completed CRFS, signed ICFs, etc.) need to be preserved and managed in accordance with the requirements of GCP. The research center should keep these documents for five years after the end of the research. Research documents should be properly preserved for future access or data traceability. When saving files, security and environmental risks should be taken into consideration. The researchers agreed that the relevant regulatory authorities could have direct access to all research-related documents, including the medical records of the subjects.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-10-11 12:13:57