ChiCTR2500096627 版本V1.0 版本创建时间2025/01/27 09:06:24 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：

ChiCTR2500096627 

最近更新日期：

Date of Last Refreshed on：

2025-01-27 09:06:17 

注册时间：

Date of Registration：

2025-01-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

TACE联合信迪利单抗和仑伐替尼新辅助治疗对比一期手术治疗可切除的单发大肝细胞癌 （>5cm）的临床研究

Public title：

To compare neoadjuvant TACE plus sintilimab and lenvatinib with one-stage surgery for resectable, single, large hepatocellular carcinoma (>5cm)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

TACE联合信迪利单抗和仑伐替尼新辅助治疗对比一期手术治疗可切除的单发大肝细胞癌 （>5cm）的临床研究

Scientific title：

To compare neoadjuvant TACE plus sintilimab and lenvatinib with one-stage surgery for resectable, single, large hepatocellular carcinoma (>5cm)

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：

杨云 

研究负责人：

周伟平/杨云 

Applicant：

Yang Yun 

Study leader：

Zhou Weiping/Yang Yun 

申请注册联系人电话：

Applicant telephone：

+86 136 1180 7893

研究负责人电话：

Study leader's telephone：

+86 136 0161 6763

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：

cloudehbh@126.com

研究负责人电子邮件：

Study leader's E-mail：

ehpnwp@126.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：

上海市长海路225号

研究负责人通讯地址：

上海市长海路225号

Applicant address：

225 Changhai Road, Shanghai

Study leader's address：

225 Changhai Road, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200438

研究负责人邮政编码：

Study leader's postcode：

200438

申请人所在单位：

海军军医大学第三附属医院

Applicant's institution：

The Third Affiliated Hospital of Naval Medical University

研究负责人所在单位：

海军军医大学第三附属医院

Affiliation of the Leader：

The Third Affiliated Hospital of Naval Medical University

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：

EHBHKY2024-H017-P001

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：

上海东方肝胆外科医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shanghai Eastern Hepatobiliary Surgery Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-06-10 00:00:00

伦理委员会联系人：

邰小云

Contact Name of the ethic committee：

Tai Xiaoyun

伦理委员会联系地址：

上海市长海路225号

Contact Address of the ethic committee：

225 Changhai Road, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 152 2139 0719

伦理委员会联系人邮箱：

Contact email of the ethic committee：

378834858@qq.com

研究实施负责（组长）单位：

海军军医大学第三附属医院

Primary sponsor：

The Third Affiliated Hospital of Naval Medical University

研究实施负责（组长）单位地址：

上海市长海路225号

Primary sponsor's address：

225 Changhai Road, 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(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

海军军医大学第三附属医院

具体地址：

上海市长海路225号

Institution
hospital：

The Third Affiliated Hospital of Naval Medical University

Address：

225 Changhai Road, Shanghai

经费或物资来源：

相关药品生产厂家赠药

Source(s) of funding：

Relevant medications were provided as donations by the manufacturers

Target disease：

Hepatocellular carcinoma

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：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的： 1.接受术前TACE联合信迪利单抗和仑伐替尼新辅助治疗组的术后无复发生存期（Recurrence-Free Survival, RFS）。 次要目的： 2.接受术前TACE联合信迪利单抗和仑伐替尼新辅助治疗组的不良事件和严重不良事件以及术后并发症的发生率，新辅助治疗后1年总体生存率（1-year OS）、3年总体生存率（3-year OS）以及1年无复发生存率（1-year RFS）、2年无复发生存率（2-year RFS）、3年无复发生存率（3-year RFS）。 3.根据RECIST1.1评估的客观缓解率，新辅助治疗后R0切除率、病理学完全缓解（pCR）率、主要病理缓解（mPR）率（MPR，即主要病理缓解率：指瘤床上残留的肿瘤活性细胞占比≤50%；MPR 率即达到主要病理缓解的受试者所占的百分比例）、微血管侵犯(MVI)检出率。 探索性目的： 探索术前TACE联合信迪利单抗以及仑伐替尼用于可切除的单发大肝细胞癌（>5cm）围手术期的疗效预测指标。  

Objectives of Study：

Primary Objective: To evaluate the recurrence-free survival (RFS) of patients undergoing neoadjuvant therapy with TACE combined with sintilimab and lenvatinib before surgery. Secondary Objectives: To assess the incidence of adverse events (AEs), serious adverse events (SAEs), and postoperative complications in the neoadjuvant TACE combined with sintilimab and lenvatinib group. To determine the 1-year overall survival (1-year OS), 3-year overall survival (3-year OS), 1-year recurrence-free survival (1-year RFS), 2-year recurrence-free survival (2-year RFS), and 3-year recurrence-free survival (3-year RFS) after neoadjuvant therapy. To evaluate the objective response rate (ORR) based on RECIST 1.1 criteria, R0 resection rate after neoadjuvant therapy, pathological complete response (pCR) rate, and major pathological response (MPR) rate (MPR refers to the percentage of patients with ≤50% residual viable tumor cells in the tumor bed; MPR rate represents the proportion of patients achieving MPR). To assess the detection rate of microvascular invasion (MVI). Exploratory Objective: To identify potential perioperative efficacy predictors for neoadjuvant TACE combined with sintilimab and lenvatinib in the treatment of resectable large solitary hepatocellular carcinoma (>5 cm).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

受试者需要符合以下入选标准： 1. 在任何试验相关流程实施之前，签署书面知情同意； 2. 年龄18-75周岁，男女不限； 3. ECOG PS评分为0-1； 4. 经病理学或影像学确诊的肝细胞癌； 5. 肿瘤单发且最大直径超过5cm； 6. 影像学评估为可切除且肝切除术后有足够的余肝体积； 7. 无影像学可见的血管侵犯或肝外转移； 8. 既往未接受过针对肝细胞癌的局部或者全身系统性抗肿瘤治疗； 9. Child-Pugh评分A级； 10. 预期生存时间>12个月； 11. 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； 12. 充分控制血压； 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： 1）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； 2）肝功能：血清总胆红素（total bilirubin, TBIL）≤1.5×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）≤2×ULN； 血清白蛋白≥30g/L； 3）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； 4）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. 若患有乙型肝炎病毒（HBV）感染，如HBsAg 阳性，需检测HBV-DNA，且 HBV-DNA 需<2000 IU/mL（若研究中心只有copy/mL 检测单位，则需<104 copy/mL），且在随机之前至少接受 1 周抗 HBV 治疗且愿意在研究期间全程接受抗病毒治疗；丙型肝炎病毒（HCV）-RNA-阳性患者必须按治疗指南接受抗病毒治疗； 15. 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； 16. 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。预期生存时间≥12 周。

Inclusion criteria

Subjects were required to meet the following eligibility criteria: 1. Written informed consent was obtained before any trial-related procedures were performed; 2. Age 18-75 years old, male or female; 3. ECOG PS score of 0-1; 4. Hepatocellular carcinoma confirmed by pathology or imaging; 5. Single tumor with a maximum diameter of more than 5cm; 6. The imaging evaluation was resectable and there was sufficient remnant liver volume after hepatectomy; 7. There was no vascular invasion or extrahepatic metastasis. 8. Had received no previous local or systemic antitumor therapy for hepatocellular carcinoma; 9. Child-Pugh grade A; 10. Expected survival time >12 months; 11. Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal limits. (It can be controlled with thyroid replacement therapy). Asymptomatic subjects with abnormal T3, free T3 or free T4 were eligible; 12. Adequate blood pressure control; 13. Adequate organ and bone marrow function with laboratory values within 7 days before randomization (administration of any blood component, cell growth factor, albumin, or other corrective medication was not allowed within 14 days of obtaining the laboratory test), as follows: 1) Blood routine: absolute neutrophil count (ANC) >=1.5×109/L; platelet count (PLT) >=75×10 9/L; hemoglobin (HGB) >=9.0 g/dL; 2) Liver function: serum total bilirubin (TBIL) <=1.5× upper limit of normal value (ULN); alanine aminotransferase (ALT), aspartate transferase (AST) and alkaline phosphatase (ALP) <=2×ULN; Serum albumin >=30g/L; 3) Renal function: serum creatinine (Cr) <= 1.5×ULN or clearance of creatinine (CCr) >= 50mL/min (Cockcroft-Gault formula); Urine routine results showed that urine protein was less than 2+. Patients with a urine protein level of 2+ or more on routine urinalysis at baseline should undergo 24-hour urine collection with a 24-hour urinary protein quantification of less than 1g. 4) Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times ULN; 14. If you have hepatitis B virus (HBV) infection, if you are HBsAg positive, you need to test for HBV-DNA, and HBV-DNA should be <2000 IU/mL (<104 copy/mL if the research center has only copy/mL testing unit). Patients who had received anti-HBV treatment for at least 1 week before randomization and were willing to receive antiviral treatment for the whole period of the study; Hepatitis C virus (HCV) -RNA-positive patients must receive antiviral therapy according to the treatment guidelines. 15. For women of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy. 16. If there was a risk of pregnancy, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% for the entire treatment period up to 120 days after the last dose of study drug on treatment (or 180 days after the last dose of chemotherapy). The expected survival time was ≥12 weeks.

排除标准：

受试者不能有以下的任何排除标准： 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. 有中枢神经系统转移； 5. 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。首次给药前3个月内已知的内镜检查存在重度（G3）静脉曲张。有门静脉高压证据（包括影像学检查发现脾大），经研究者评估出血风险高者 ； 6. 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； 7. 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） ； 8. 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 ； 9. 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 ； 10. 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） ； 11. 严重出血倾向或凝血功能障碍，或正在接受溶栓治疗 ； 12. 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 ； 13. 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； 14. 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 ； 15. 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 ； 16. 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； 17. 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 ； 18. 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 19. 首次给药前4周之内或计划在研究期间接受减毒活疫苗 ； 20. 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 ； 21. 首次给药前2周内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） ； 22. 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 ； 23. 在随机化前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。如果随机化前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 ； 24. 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 ； 25. 已知对于任何仑伐替尼、信迪利单抗成分过敏；或既往对其他单克隆抗体或抗血管生成抑制剂产生过严重过敏反应； 26. 随机前 2 周内仍在使用强 CYP3A4 诱导剂或随机前 1 周内仍在使用强CYP3A4 抑制剂； 27. 不能吞咽药片、吸收不良综合症或任何影响胃肠吸收的状况； 28. 首次给药前4周内接受过其他临床试验的治疗 ； 29. 妊娠或哺乳的女性患者； 30. 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：

Subjects could not have any of the following exclusion criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously confirmed by histology/cytology; 2. History of hepatic encephalopathy or liver transplantation; 3. Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage; 4. Central nervous system metastasis; 5. A bleeding event of esophageal or gastric varices due to portal hypertension within the past 6 months. Known endoscopic severe (G3) varices were present within 3 months before the first dose. Patients with evidence of portal hypertension (including splenomegaly detected by imaging examination) and high risk of bleeding as assessed by the investigator; 6. Any life-threatening bleeding event in the previous 3 months, including the need for blood transfusion, surgery or local treatment, or continuous medical treatment; 7. History of arterial or venous thromboembolic events within the previous 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other major thromboembolism. Patients with venous access port or catheter-related thrombosis or superficial venous thrombosis were excluded if the thrombosis was stable after conventional anticoagulant therapy. Prophylactic use of low-dose low-molecular-weight heparin (e.g., enoxaparin 40 mg per day) was allowed. 8. Aspirin (> 325 mg/ day) or other drugs known to inhibit platelet function, such as dipyridamole or clopidogrel, for 10 consecutive days within 2 weeks before the first dose; 9. Uncontrolled hypertension, systolic blood pressure > 150mmHg or diastolic blood pressure > 90 mmHg with best medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 10. Symptomatic congestive heart failure (New York Heart Association class II-IV) Symptomatic or poorly controlled arrhythmias. A history of congenital long QT syndrome or corrected QTc > 500ms (calculated with Fridericia's method); 11. Severe bleeding tendency or coagulopathy, or receiving thrombolytic therapy; 12. History of gastrointestinal perforation and/or fistula within the previous 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 13. Previous or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of pulmonary function and other pulmonary diseases; 14. Active pulmonary tuberculosis (TB), receiving anti-TB treatment or receiving anti-TB treatment within 1 year before the first dose; 15. Human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive), known syphilis infection; 16. Severe infections that are active or poorly controlled clinically. Severe infection within 4 weeks before the first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; 17. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) were allowed. He had a known history of primary immunodeficiency. For patients with only positive autoimmune antibodies, the presence of autoimmune diseases should be determined according to the investigator's judgment. 18. Use of immunosuppressive drugs within 4 weeks before the first dose, Topical glucocorticoids administered by nasal spray, inhalation, or other route or systemic glucocorticoids at physiological doses (i.e., no more than 10mg per day of prednisone or other glucocorticoids at equivalent doses) were excluded. Temporary use of glucocorticoids was permitted for the treatment of symptoms of dyspnea in conditions such as asthma, chronic obstructive pulmonary disease, or others 19. Receipt of live attenuated vaccine within 4 weeks before the first dose or planned during the study; 20. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of medication. Tissue biopsy or other minor surgical procedures within 7 days before the first dose of dose, with the exception of venipuncture for intravenous fluids; 21. Drugs with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use to control pleural effusion or ascites) received within 2 weeks before the first dose; 22. Uncontrolled/uncorrectable metabolic disorder or other non-malignant organ disease or systemic disease or secondary reaction to cancer, and may lead to high medical risk and/or uncertainty in survival evaluation; 23. Other malignancies diagnosed within 5 years before randomization, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma. If other malignancies or liver cancer were diagnosed more than 5 years before randomization, pathological or cytologic diagnosis of recurrent or metastatic disease was required. 24. Received any previous anti-PD-1 antibody, anti-PD-L1 /L2 antibody, anti-CTLA4 antibody, or other immunotherapy. Previous targeted therapy against VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR and other signaling pathways; 25. Known to be allergic to any lenvatinib, sintilimab components; Or have had a previous severe allergic reaction to other monoclonal antibodies or antiangiogenic inhibitors; 26. Use of a strong CYP3A4 inducer within 2 weeks before randomization or use of a strong CYP3A4 inhibitor within 1 week before randomization; 27. Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption; 28. Received treatment from another clinical trial within 4 weeks before the first dose; 29. Pregnant or lactating women; 30. Other acute or chronic medical conditions, psychiatric conditions, or abnormal laboratory values that could 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 patients ineligible for the study.

研究实施时间：

Study execute time：

从 From 2025-02-01 00:00:00至 To 2027-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-02-01 00:00:00 至 To 2027-02-01 00:00:00  

干预措施：

Interventions：

组别：

新辅助治疗组

样本量：

55

Group：

Neoadjuvant Therapy group

Sample size：

干预措施：

接受术前TACE联合仑伐替尼以及信迪利单抗治疗（1-N个治疗周期）。第一次TACE在随机后的一周内完成，TACE后三天内给予仑伐替尼以及信迪利单抗治疗。第二次信迪利单抗在第一次信迪利单抗给药后三周再次给药，第三次信迪利单抗在第二次信迪利单抗给药后三周再次给药（以此类推），TACE的治疗次数根据按需决定（On -demand TACE）

干预措施代码：

Intervention：

Patients in this group receive preoperative TACE combined with lenvatinib and sintilimab for 1–N treatment cycles. The first TACE procedure is completed within one week after randomization. Lenvatinib and sintilimab are initiated within three days following the first TACE. The second dose of sintilimab is administered three weeks after the first dose, and subsequent doses of sintilimab are administered every three weeks thereafter. The number of TACE procedures is determined based on an on-demand strategy.

Intervention code：

组别：

对照组

样本量：

55

Group：

Control group

Sample size：

干预措施：

根治性手术+术后4周信迪利单抗+仑伐替尼抗复发治疗半年。

干预措施代码：

Intervention：

Radical surgery + sintilimab + lenvatinib 4 weeks after surgery for half a year.

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)：

海军军医大学第三附属医院 

单位级别：

三甲 

Institution
hospital：

The Third Affiliated Hospital of Naval Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无复发生存时间（RFS）：指患者从手术之日起到肿瘤复发之间的时间

指标类型：

主要指标

Outcome：

Recurrence-Free Survival (RFS): Defined as the time from the date of surgery to the recurrence of the tumor.

Type：

Primary 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：

肝癌组织

Sample Name：

Blood

Tissue：

HCC

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）：

随机序列由研究团队中的统计学人员使用SPSS软件生成，采用简单随机化方法生成随机数。随机分配过程由独立研究助理负责实施，并采用封闭信封法（或其他适当的随机化隐藏方法）以确保分配隐藏，避免选择偏倚。

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

The random sequence was generated using SPSS software by a statistician within the research team, employing the simple randomization method. The random allocation process was implemented by an independent research assistant, using a sealed envelope method (or another appropriate allocation concealment method) to ensure allocation concealment and avoid selection bias.

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：

无

Blinding：

None

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

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：

病历记录表和电子采集和管理系统

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

Case Record Form and Electronic Data Capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-01-27 09:06:17