Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized, open-label, parallel-group, active controlled, multi-center phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab (hereafter referred to as JS001) combined with Bevacizumab versus Sorafenib as the first-line therapy for advanced HCC This study will enroll the patients with locally advanced or metastatic hepatocellular carcinoma who could not be radically cured and not receive any prior systemic therapy. The study will use PFS and OS as the co-primary endpoints, with approximately 280 patients planned to be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | Toripalimab combined with Bevacizumab |
|
| Control group | Active Comparator | Sorafenib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab combined with Bevacizumab | Combination Product | Experimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Bevacizumab 15mg/kg, IV infusion, every 3 weeks (q3w), Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | A duration from the date of initial treatment with Toripalimab Plus Bevacizumab or Sorafenib to disease progression (defined by RECIST 1.1) or death of any cause, whichever comes first. | Up to 2 years |
| Overall survival (OS) | Duration from the date of initial treatment with Toripalimab Plus Bevacizumab or Sorafenib monotherapy to the date of death due to any cause. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The rate of participants that achieve either a complete response (CR) or a partial response (PR). | Up to 2 years |
| DoR | Duration from the first time reported partial response or complete response to the first time of disease progression or death. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical college | Bengbu | Anhui | 233000 | China | ||
| Anhui Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40409323 | Derived | Shi Y, Han G, Zhou J, Shi X, Jia W, Cheng Y, Jin Y, Hua X, Wen T, Wu J, Gu S, Bai Y, Wang X, Zhang T, Chen Z, Zhang B, Huang M, Liu H, Mao Y, Zhou L, Wang R, Shan Y, Zhang W, Song T, Guo Y, Zhou F, Shao B, Zhang M, Liang B, Zheng J, Zhang G, Shen J, Su W, Zhang F, He Y, Hu S, Liu R, Zhang C, Shen S, Zeng H, Wang TE, Guo W, Shen Y, Chen Y, Li Y, Samol J, Hu H, Zhang W, Du C, Li E, Liu C, Pin CS, Li X, Xu H, Huang JF, Hao C, Lv J, Wang W, Xu Q, Bai A, Zhang X, Liu B, Jin C, Fan J. Toripalimab plus bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma (HEPATORCH): a randomised, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2025 Jul;10(7):658-670. doi: 10.1016/S2468-1253(25)00059-7. Epub 2025 May 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sorafenib | Drug | Control group: Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol. |
|
| Up to 2 years |
| Disease Control Rate (DCR) | Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease | Up to 2 years |
| TTP | Define as the time from randomization to the first documented disease progression | Up to 2 years |
| Incidence of AEs/SAEs as Assessed by CTCAE v5.0 | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0 | From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years. |
| TMB | Correlation between tumor mutation burden (TMB) and the efficacy of Toripalimab combined with Bevacizumab | Up to 12 years |
| ADA | Serum levels and incidence of Anti-drug antibody of Toripalimab combined with Bevacizumab treatment group | Up to 12 years |
| Hefei |
| Anhui |
| 230000 |
| China |
| Anhui Provincial Hospital | Hefei | Anhui | 230000 | China |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230000 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100000 | China |
| China PLA General Hospital | Beijing | Beijing Municipality | 100000 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
| Army Medical Center of PLA | Chongqing | Chongqing Municipality | 400000 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China |
| The Southwest Hospital Of AMU | Chongqing | Chongqing Municipality | 400000 | China |
| The Frist Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| Gansu Wuwei Tumor Hospital | Wuwei | Gansu | 733000 | China |
| The First Peoples Hospital of Foshan | Foshan | Guangdong | 528000 | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | 510000 | China |
| SSun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| Yuebei People's Hospital | Shaoguan | Guangdong | 512000 | China |
| Hainan General Hospital | Haikou | Hainan | 570100 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| he First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450000 | China |
| Henan Provincial Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410000 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China |
| NanJing Drum Tower Hospital | Nanjing | Jiangsu | 210000 | China |
| Nantong Tumor Hospital | Nantong | Jiangsu | 226000 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| The First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi | 341000 | China |
| The first Affiliated hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The Second Affiliated hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130000 | China |
| Jilin Guowen Hospital | Changchun | Jilin | 130000 | China |
| Liaoning cancer hospital | Shenyang | Liaoning | 110000 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250000 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| First Affiliated Hospital of Xian Jiaotong University | Xi’an | Shanxi | 710000 | China |
| Xi'an International Medical Center Hospital | Xi’an | Shanxi | 710000 | China |
| Sichuan Cancer Hospital | Chengdu | Sichuan | 610000 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610000 | China |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Gaoxiong | Taiwan | 000800 | China |
| MacKay Memorial Hospital | Taibei | Taiwan | 100 | China |
| Changhua Christian Hospital | Zhanghua | Taiwan | 000500 | China |
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Yunnan Cancer Hospital | Kunming | Yunnan | 650000 | China |
| ShuLan(HangZhou) Hospital | Hangzhou | Zhejiang | 310000 | China |
| The First Affiliated Hospital,Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | China |
| ZheJiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
| ZheJiang Provincial People's Hospital | Hangzhou | Zhejiang | 310000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| Tongji Hospital Tongji Medical College Of HUST | Wuhan | Zhejiang | 430000 | China |
| Xiehe Hospital Tongji Medical College Of HUST | Wuhan | Zhejiang | 430000 | China |
| Zhongnan Hospital of Wuhan University | Wuhan | Zhejiang | 430000 | China |
| Jia Fan | Shanghai | 130061 | China |
| Curie Oncology | Singapore | 999002 | Singapore |
| Tan Tock Seng Hospital | Singapore | 999002 | Singapore |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided