ChiCTR2400089240 版本V1.0 版本创建时间2024/09/04 11:13:31 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：

 ChiCTR2400089240 

最近更新日期：

Date of Last Refreshed on：

 2024-09-04 11:12:55 

注册时间：

Date of Registration：

 2024-09-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项单臂、单中心的研究评估信迪利单抗联合达攸同作为新辅助治疗用于复发可切除肝细胞癌（HCC）患者的探索性研究

Public title：

Sindilimab in Combination With Bevacizumab as a Neoadjuvant Therapy in Patients With Relapsed Resectable Hepatocellular Carcinoma (HCC):An Open, Single-arm, Single-center Prospective Study.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项单臂、单中心的研究评估信迪利单抗联合达攸同作为新辅助治疗用于复发可切除肝细胞癌（HCC）患者的探索性研究

Scientific title：

Sindilimab in Combination With Bevacizumab as a Neoadjuvant Therapy in Patients With Relapsed Resectable Hepatocellular Carcinoma (HCC):An Open, Single-arm, Single-center Prospective 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：

傅修涛 

研究负责人：

丁振斌 

Applicant：

Fu Xiutao 

Study leader：

Ding Zhenbin 

申请注册联系人电话：

Applicant telephone：

 +86 139 1697 7063

研究负责人电话：

Study leader's
telephone：

+86 136 3638 8572

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：

 fu.xiutao@zs-hospital.sh.cn

研究负责人电子邮件：

Study leader's E-mail：

 ding.zhenbin@zs-hospital.sh.cn

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：

上海市徐汇区枫林路180号

研究负责人通讯地址：

上海市徐汇区枫林路180号

Applicant address：

180 Fenglin Road, Xuhui District, Shanghai

Study leader's address：

180 Fenglin Road, Xuhui District, Shanghai

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：

复旦大学附属中山医院

Applicant's institution：

Zhongshan Hospital

研究负责人所在单位：

复旦大学附属中山医院

Affiliation of the Leader：

Zhongshan 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：

 B2024-172R

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：

复旦大学附属中山医院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Zhongshan Hospital Fudan Unive

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-07-16 00:00:00

伦理委员会联系人：

杨梦婕

Contact Name of the ethic committee：

Yang Mengjie

伦理委员会联系地址：

上海市徐汇区枫林路180号

Contact Address of the ethic committee：

180 Fenglin Road, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 3158 7871

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：

复旦大学附属中山医院

Primary sponsor：

Zhongshan Hospital

研究实施负责（组长）单位地址：

上海市徐汇区枫林路180号

Primary sponsor's address：

180 Fenglin Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属中山医院

具体地址：

上海市徐汇区枫林路180号

Institution
hospital：

Zhongshan Hospital

Address：

180 Fenglin Road, Xuhui District, Shanghai

经费或物资来源：

复旦大学附属中山医院

Source(s) of funding：

Zhongshan Hospital

研究疾病：

肝细胞癌  

Target disease：

hepatocellular carcinoma

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：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

评价信迪利单抗联合达攸同作为新辅助治疗用于可复发切除肝细胞癌(HCC)患者的初步疗效。  

Objectives of Study：

To evaluate the preliminary efficacy of sintilimab combined with Bevacizumab Injection as neoadjuvant therapy in patients with relapsed and resectable hepatocellular carcinoma (HCC).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

满足下列所有标准的患者方有资格参与试验 1) 经病理组织学检查确诊为肝细胞肝癌； 2) 筛选期肝肿瘤穿刺标本癌内CD8+T细胞达到5%以上 3) 符合可切除手术标准： a) 东部肿瘤协作组（ECOG）PS评分0分； b) 根据《原发性肝癌诊疗规范》（2022年版），肝脏储备功能良好的可手术IIb和IIIa期患者（需研究者严格把握可手术标准）以及Ia期、Ib期和IIa期患者。肝癌临床分期具体见附件3； c) Child-Pugh A级。Child-Pugh肝功能分级见附件2； d) 无门静脉主干癌栓和胆管侵犯； e) 无邻近脏器侵犯，无肝门淋巴结或远处转移。 4) 具有至少一个根据RECIST1.1标准的可评估病灶，并未接受局部治疗； 5) 手术后复发的肝细胞癌患者，复发时间距手术至少6个月，还符合可切除手术标准，且具有至少一个根据RECIST 1.1标准的可评估病灶，并未接受局部治疗的，可以入组； 6) 对本研究已充分了解并自愿签署书面知情同意； 7) 年龄在18至75岁，性别不限； 8) 研究者认为患者有能力依从方案； 9) 同意提供新鲜或者既往存储的病灶组织及癌旁组织以及手术标本；必须提供上述标本的相关病理学报告； 10) 新辅助治疗开始前7天内实验室检查值必须符合以下标准： a) 中性粒细胞≥1.5 × 10^9/L； b) 血小板≥75 × 10^9/L； c) 血红蛋白≥90g/L（2周内未输注浓缩红细胞）； d) 血肌酐≤1.5 × 正常值上限（ULN） e) 天门冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）≤ 2.5 × ULN； f) 血清白蛋白≥30 g/L； g) 未接受抗凝治疗的患者：INR或aPTT≤1.5 × ULN. 如果患者接受预防性抗凝治疗，新辅助研究治疗开始前14天内INR≤2 × ULN且aPTT在正常值范围内，可接受入组； h) 血清胆红素≥1.25 × ULN 11) 入组前21天内，育龄期女性必须确认血清妊娠试验为阴性并同意在研究药物使用期间以及研究药物末次给药后60天内采用有效避孕措施。年避孕失败率＜1%的避孕方法实例包括双侧输卵管结扎、男性绝育、抑制排卵的激素类避孕药、激素释放型宫内节育器和铜环宫内节育器。或双重屏障避孕措施，定义为含有杀精子胶、泡沫、栓剂或薄膜的避孕套; 或含杀精剂的隔膜以及男用避孕套和隔膜。应相对于临床试验持续时间以及患者偏爱的生活方式和日常生活方式，评价性欲节制的可靠性。周期性禁欲（例如，日历日、排卵期、症状体温或排卵后方法）和体外射精是不可接受的避孕方法。本方案中育龄期女性定义为性成熟女性： a) 未经历子宫切除术或双侧卵巢切除术； b) 自然停经未持续连续的12个月（癌症治疗后闭经不排除有生育能力）（即，在之前连续的12个月内的任何时间出现过月经）。

Inclusion criteria

Patients who meet all of the following criteria are eligible to participate in the trial 1) Diagnosed as hepatocellular carcinoma through histopathological examination; 2) During the screening period, intra-cancer CD8+ T cells in liver tumor biopsy specimens reach more than 5% 3) Meet the criteria for resectable surgery: a) Eastern Cooperative Oncology Group (ECOG) PS score 0; b) According to the "Standards for Diagnosis and Treatment of Primary Liver Cancer" (2022 Edition), operable stage IIb and IIIa patients with good liver reserve function (researchers need to strictly grasp the operable criteria) and stage Ia, Ib and IIa patients. Please see Appendix 3 for details of clinical staging of liver cancer; c) Child-Pugh Class A. Child-Pugh liver function classification is shown in Appendix 2; d) No main portal vein tumor thrombus or bile duct invasion; e) No invasion of adjacent organs, no hilar lymph nodes or distant metastasis. 4) Have at least one evaluable lesion according to RECIST1.1 criteria and have not received local treatment; 5) Patients with hepatocellular carcinoma who relapse after surgery, who relapse at least 6 months after surgery, meet the criteria for resectable surgery, and have at least one evaluable lesion according to RECIST 1.1 criteria, who have not received local treatment, can be enrolled. ; 6) Fully understand this study and voluntarily sign written informed consent; 7) Aged between 18 and 75 years old, regardless of gender; 8) The researcher believes that the patient has the ability to comply with the protocol; 9) Agree to provide fresh or previously stored lesion tissue, adjacent tissue and surgical specimens; relevant pathology reports of the above specimens must be provided; 10) Laboratory test values ??within 7 days before the start of neoadjuvant therapy must meet the following standards: a) Neutrophils ≥1.5 × 10^9/L; b) Platelets ≥75 × 10^9/L; c) Hemoglobin ≥90g/L (no concentrated red blood cells transfused within 2 weeks); d) Serum creatinine ≤1.5 × upper limit of normal (ULN) e) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; f) Serum albumin ≥30 g/L; g) Patients not receiving anticoagulant therapy: INR or aPTT ≤1.5 × ULN. If the patient receives prophylactic anticoagulant therapy, INR ≤2 × ULN and aPTT within the normal range, they are accepted for enrollment; h) Serum bilirubin ≥1.25 × ULN 11) Within 21 days before enrollment, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the use of the study drug and within 60 days after the last dose of the study drug. Examples of contraceptive methods with an annual contraceptive failure rate of <1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper ring intrauterine devices. Or double barrier contraceptive measures, defined as condoms containing spermicide gel, foam, suppository, or film; or diaphragms containing spermicide and male condoms and diaphragms. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (e.g., calendar day, ovulation period, symptom temperature, or post-ovulation method) and withdrawal are unacceptable contraceptive methods. In this protocol, women of childbearing age are defined as sexually mature women: a) who have not undergone hysterectomy or bilateral oophorectomy; b) whose natural menopause has not lasted for 12 consecutive months (amenorrhea after cancer treatment does not exclude fertility) (i.e., they have had menstruation at any time in the previous 12 consecutive months)

排除标准：

符合下列任何一条标准的患者将不得进入本项研究： 1) 既往接受过抗程序性死亡受体-1（PD-1）抗体、抗程序性死亡配体-1（PD-L1）抗体、抗程序性死亡配体-2（PD-L2）抗体或抗细胞毒T淋巴细胞相关抗原-4（CTLA-4）抗体的患者，包括参加过信迪利单抗临床研究的患者； 2) 肝脏复发灶接受过任何TACE、射频消融等其它肝癌局部治疗及化疗等系统抗肿瘤治疗的患者； 3) 在随机前6个月内有消化道出血病史；有门静脉高压的患者，研究者认为出血风险高的患者（包括有出血风险的中重度食管胃底静脉曲张，局部活动性消化道溃疡以及持续大便隐血阳性），需要进行胃镜检查，排除有“红色征”的患者。如果胃镜检查历史有“红色征”，需排除入组； 4) 已知有纤维板层HCC、肉瘤样HCC或混合型胆管癌和HCC； 5) 存在活动性中枢神经系统（CNS）转移症状和/或癌性脑膜炎, 或有无法控制的重大癫痫症患者，除非经过CT或MRI检查排除； 6) 有任何活动性自身免疫性疾病或自身免疫疾病病史（自身免疫性肝炎、间质性肺炎、葡萄膜炎、系统性红斑狼疮、类风湿性关节炎、炎性肠病、抗磷脂综合征相关的血管血栓形成、Wegener's肉芽肿病、干燥综合征、格林－巴利综合征、多发性硬化、血管炎、肾小球肾炎等、甲状腺功能亢进或减退、需支气管扩张剂进行治疗的哮喘）：甲状腺功能减退但接受稳定剂量的甲状腺激素替代疗法的患者除外； 7) 未控制的胸腔积液、心包积液，或中等量以上腹水； 8) 有任何肾病或肾病综合征病史； 9) 原有严重的心、脑血管疾病史： a) 随机前12个月内出现纽约心脏病协会（NYHA）II级以上的充血性心力衰竭、不稳定型心绞痛、心肌梗死或脑血管意外卒中，或控制不良的心律失常； b) 心脏彩超检查左室射血分数（LVEF）<50%； c) 校正的QT间期（QTc）> 480ms（使用Fridericia方法计算，若QTc异常，可间隔2分钟连续检测3次，取其平均值）； d) 3种降压药物难以控制的高血压（收缩压≥140 mmHg和/或舒张压≥90mmHg）； e) 既往曾经发生高血压危象或高血压脑病。 10) 患有特发性肺纤维化病史、机化性肺炎（如闭塞性细支气管炎）、药物性肺炎、特发性肺炎或胸部增强CT扫描筛选时发现活动性肺炎证据；放射区具有放射性肺炎（纤维化）病史的患者除外； 11) 入组前2周接受过重大手术，尚未从之前的手术中完全恢复； 12) 有活动性出血或凝血功能异常（活化部分凝血酶时间（aPTT）> 43 s、凝血酶时间（国际标准化比率（INR）> 1.5×ULN）、具有出血倾向或正在接受溶栓或抗凝治疗；允许针对开放的静脉输液系统进行预防性抗凝治疗，只要在开始研究治疗之前14天内药物活性使INR ≤2×ULN和aPTT在正常范围内即可。 13) 已知对于信迪利单抗、达攸同及辅料过敏，或既往对其他单克隆抗体产生过严重过敏反应； 14) 既往接受过同种异体干细胞或实质器官移植的患者，包括肝移植术后的患者； 15) 无法纠正的血清钾、钙或镁等电解质紊乱病史 16) 已知人类免疫缺陷病毒（HIV）感染； 17) 乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）活动感染者： a) 活动性病毒性肝炎定义为：HBV感染且乙型肝炎病毒脱氧核糖核酸（HBV DNA）≥ 500 IU/mL；或HCV感染； b) 如果HBsAg(+)和/或HBcAb(+)，在首次给药前28天内，该类患者在各研究中心检测的HBV DNA结果必须<500 IU/mL或低于其参考值下限，在随机前最少14天内开始并在研究期间全程继续接受抗HBV病毒治疗（按本地治疗标准，如恩替卡韦），可参与本项研究。若受试者 HBcAb(+)，但HBsAg(-)且HBV DNA <500 IU/mL，研究者可根据患者具体情况决定是否进行抗病毒治疗； c) HCV 抗体检测结果阳性的患者，仅当丙型肝炎病毒核糖核酸（HCV RNA）的聚合酶链式反应（PCR）检测结果为阴性时，方可入选本研究； d) 如果患者入组时正在接受抗病毒治疗，要求在整个研究过程中维持稳定的抗病毒治疗，任何有依从性顾虑的患者，均不可入组。 18) 怀孕或者哺乳期女性患者，或试验期间不愿意避孕者； 19) 入组前5年内有除肝细胞癌外的恶性肿瘤病史，除外某些转移或死亡风险忽略不计（例如预期5年总生存期（OS）> 90%），且经治疗后预期可痊愈的恶性肿瘤（如已经适当治疗的宫颈原位癌，基底或鳞状细胞皮肤癌，接受根治性手术治疗的局限性前列腺癌，根治性手术治疗的导管原位癌）； 20) 使用免疫抑制剂、或全身、或可吸收的局部激素治疗以达到免疫抑制目的（剂量>10 mg/天泼尼松或其他等效价激素），并在入组前2周内仍在继续使用的； 21) 患有活动性肺结核（TB）的患者，正在接受抗结核治疗或者筛选前1年内接受过抗结核治疗； 22) 活动性感染，或者新辅助治疗开始前2周内接受过口服或静脉抗生素治疗，预防性用药除外； 23) 新辅助治疗开始前4周内接种过任何抗感染疫苗（如流感疫苗、水痘疫苗等）； 24) 在新辅助治疗开始前28天内，接受了其他试验药物治疗或参与其他治疗目的的临床研究； 25) 任何其它疾病、代谢障碍、体检结果或实验室检查异常结果，并有理由怀疑可能导致禁忌使用试验药物、或影响研究结果可靠性、或使患者处于高风险的治疗并发症的疾病或病症，或者影响患者的依从性。

Exclusion criteria：

Patients who meet any of the following criteria will not be allowed to enter this study: 1) Patients who have previously received anti-programmed death receptor-1 (PD-1) antibody, anti-programmed death ligand-1 (PD-L1) antibody, anti-programmed death ligand-2 (PD-L2) antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody, including patients who have participated in clinical studies of sintilimab; 2) Patients who have received any TACE, radiofrequency ablation or other local treatments for liver cancer and systemic anti-tumor treatments such as chemotherapy for liver recurrence; 3) Patients with a history of gastrointestinal bleeding within 6 months before randomization; patients with portal hypertension, patients who are considered by the researchers to have a high risk of bleeding (including moderate to severe esophageal varices with bleeding risk, local active gastrointestinal ulcers and persistent occult blood in the stool), need to undergo gastroscopy to exclude patients with "red signs". If the history of gastroscopy shows a "red sign", the patient shall be excluded from the group; 4) Patients with known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; 5) Patients with active central nervous system (CNS) metastasis symptoms and/or carcinomatous meningitis, or patients with uncontrolled severe epilepsy, unless excluded by CT or MRI examination; 6) Patients with any active autoimmune disease or history of autoimmune disease (autoimmune hepatitis, interstitial pneumonia, uveitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-related vascular thrombosis, Wegener's granulomatosis, Sj?gren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis, etc., hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment): Patients with hypothyroidism but receiving stable doses of thyroid hormone replacement therapy are excluded; 7) Uncontrolled pleural effusion, pericardial effusion, or ascites of moderate or above volume; 8) Any history of renal disease or nephrotic syndrome; 9) Previous history of severe cardiovascular and cerebrovascular diseases: a) Congestive heart failure of New York Heart Association (NYHA) grade II or above, unstable angina, myocardial infarction or cerebrovascular accident stroke, or poorly controlled arrhythmia within 12 months before randomization; b) Left ventricular ejection fraction (LVEF) <50% on cardiac ultrasound; c) Corrected QT interval (QTc) > 480ms (calculated using Fridericia method, if QTc is abnormal, it can be tested three times with an interval of 2 minutes and the average value is taken); d) Hypertension that is difficult to control with 3 antihypertensive drugs (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg); e) Previous hypertensive crisis or hypertensive encephalopathy. 10) Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia during screening of chest enhanced CT scans; except for patients with a history of radiation pneumonia (fibrosis) in the radiation area; 11) Patients who have undergone major surgery 2 weeks before enrollment and have not fully recovered from the previous surgery; 12) Patients with active bleeding or abnormal coagulation function (activated partial thromboplastin time (aPTT) > 43 s, thrombin time (international normalized ratio (INR) > 1.5×ULN), bleeding tendency, or receiving thrombolytic or anticoagulant therapy; prophylactic anticoagulation therapy for open intravenous infusion systems is allowed, as long as the drug activity within 14 days before the start of study treatment makes INR ≤2×ULN and aPTT within the normal range. 13) Patients with known allergies to sintilimab, daconazole, and excipients, or have had severe allergic reactions to other monoclonal antibodies in the past; 14) Patients who have received allogeneic stem cell or solid organ transplantation, including patients after liver transplantation; 15) History of uncorrectable electrolyte disorders such as serum potassium, calcium or magnesium 16) Known human immunodeficiency virus (HIV) infection; 17) Patients with active hepatitis B virus (HBV) and hepatitis C virus (HCV) infection: a) Active viral hepatitis is defined as: HBV infection and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 500 IU/mL; or HCV infection; b) If HBsAg (+) and/or HBcAb (+), within 28 days before the first dose, the HBV DNA results of such patients tested in each research center must be <500 IU/mL or below the lower limit of its reference value, and they must receive anti-HBV viral treatment (according to local treatment standards, such as entecavir) at least 14 days before randomization and continue to receive anti-HBV viral treatment throughout the study period to participate in this study. If the subject has HBcAb(+), but HBsAg(-) and HBV DNA <500 IU/mL, the researcher can decide whether to conduct antiviral treatment based on the patient's specific situation; c) Patients with positive HCV antibody test results can only be included in this study if the polymerase chain reaction (PCR) test result of hepatitis C virus ribonucleic acid (HCV RNA) is negative; d) If the patient is receiving antiviral treatment at the time of enrollment, it is required to maintain stable antiviral treatment throughout the study. Any patient with compliance concerns shall not be included. 18) Pregnant or lactating female patients, or those who are unwilling to use contraception during the trial; 19) A history of malignant tumors other than hepatocellular carcinoma within 5 years before enrollment, excluding certain malignant tumors with negligible risk of metastasis or death (e.g. expected 5-year overall survival (OS) > 90%), and expected to be cured after treatment (such as appropriately treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, ductal carcinoma in situ treated with radical surgery); 20) Using immunosuppressants, or systemic or absorbable local hormone therapy for immunosuppression purposes (dose > 10 mg/day prednisone or other equivalent hormones), and continuing to use them within 2 weeks before enrollment; 21) Patients with active pulmonary tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening; 22) Active infection, or received oral or intravenous antibiotics within 2 weeks before the start of neoadjuvant therapy, excluding prophylactic medication; 23) Any anti-infection vaccine (such as influenza vaccine, varicella vaccine, etc.) received within 4 weeks before the start of neoadjuvant therapy; 24) Received other trial drug treatment or participated in clinical research for other treatment purposes within 28 days before the start of neoadjuvant therapy; 25) Any other disease, metabolic disorder, abnormal physical examination results or laboratory test results, and there is reason to suspect that the disease or condition may lead to contraindications to the use of trial drugs, or affect the reliability of research results, or put patients at high risk of treatment complications, or affect patient compliance.

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-10-01 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 20

Group：

Test group

Sample size：

干预措施：

信迪利单抗+贝伐珠单抗

干预措施代码：

Intervention：

Sindilimab+Bevacizumab

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 复旦大学附属中山医院 

单位级别：

 三甲 

Institution
hospital：

Zhongshan Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

病理缓解率

指标类型：

主要指标

Outcome：

pathological response rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

Objective relief rate

Type：

Secondary 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：

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：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

肝组织

组织：

肝脏

Sample Name：

Liver tissue

Tissue：

Liver

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：

尚未开始

Not yet 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:

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

否No

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）：

无

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

none

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：

EDC

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

EDC

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：

  2024-09-04 11:12:55