Evaluate the Safety and Efficacy of Toripalimab Combined With Bevacizumab Versus Sorafenib Therapy for HCC
NCT ID: NCT04723004
Last Updated: 2023-08-14
Study Results
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Basic Information
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UNKNOWN
PHASE3
326 participants
INTERVENTIONAL
2020-10-15
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Experimental group
Toripalimab combined with Bevacizumab
Toripalimab combined with Bevacizumab
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.
Control group
Sorafenib
Sorafenib
Control group:
Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol.
Interventions
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Toripalimab combined with Bevacizumab
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.
Sorafenib
Control group:
Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol.
Eligibility Criteria
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Inclusion Criteria
2. Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients per the American Association for the Study of Liver Diseases (AASLD) guideline.
3. Unresectable BCLC B/C
4. No previous systemic therapy for HCC, patients with prior adjuvant therapy alone who relapsed at 6 months or above after the last adjuvant therapy may be enrolled.
5. ≥ 1 measurable lesion per RECISTv1.1.
6. Child-Pugh class A, with no history of hepatic encephalopathy.
7. ECOG PS 0 or 1.
8. Predicted life expectancy ≥12 weeks.
9. adequate main organ functions
10. In case of HBsAg (+) and/or HBcAb (+), HBV DNA is required to be \< 2000 IU/mL. Patients with anti-HCV antibody positive and HCV- RNA\>1000 copies/mL will be excluded; HBV/HCV co-infected patients will be excluded. patients with a prior history of HCV infection who tested negative for HCV-RNA can be considered HCV uninfected.
11. Female subjects of childbearing potential must receive serum pregnancy test within 7 days before randomization and the result should be negative, and should be willing to adopt reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug. The male patients whose partners are women of childbearing potential must agree to use reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug.
12. Being voluntary to participate in the study, sufficiently informed consent and signature of written informed consent form, with good compliance.
Exclusion Criteria
2. History of malignancy other than HCC within 5 years prior to screening.
3. Hepatic surgery and/or local therapy or investigational treatment with for HCC within 4 weeks prior to randomization, or palliative radiotherapy for bone metastatic lesion within 2 weeks prior to randomization, or Chinese medicine preparation with anti-liver cancer effect within 2 weeks prior to randomization, and non-recovery (not recovered to ≤ NCI-CTCAE v5.0 grade 1) from side effects of any such treatment (except alopecia).
4. Prior other anti-PD-1 antibody therapy or other immunotherapy against PD- 1 / PD-L1.
5. Uncontrolled pericardial effusion, uncontrolled pleural effusion or clinically obvious moderate/severe pleural effusion at screening.
6. History of gastrointestinal hemorrhage within 6 months prior to randomization; the patients with portal hypertension need to receive gastroscopy to exclude the patients with "red sign", if they are considered by investigators to have high risk for hemorrhage (including moderate-to-severe esophageal and/or gastric varices with hemorrhagic risk, locally active peptic ulcer and persistent fecal occult blood (+)). The patient needs to be excluded if there is a history of "red sign" in gastroscopy.
7. Having ≥ grade 3 (NCI-CTC AE v5.0) gastrointestinal or non- gastrointestinal fistula at present.
8. Cancer thrombus in the main trunk of portal vein involving contralateral portal vein branch, or involving superior mesenteric vein. Cancer thrombus in inferior vena cava should be excluded.
9. Serious cardiovascular and cerebrovascular diseases
10. Having major bleeding and coagulation disorders or other obvious evidence on hemorrhagic tendency:
11. Medium to large surgical treatment within 4 weeks prior to randomization (except diagnostic biopsy).
12. Central nervous system metastases.
13. Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture.
14. Vaccination of live vaccine within 30 days prior to randomization.
15. Active autoimmune diseases requiring systemic treatment (i.e., immunomodulatory drug, corticosteroid or immunosuppressant) in the past 2 years; however, replacement therapy (e.g., thyroxine, insulin or physiological corticosteroid replacement therapy for renal or pituitary insufficiency), inhaled or topical corticosteroids will not be excluded.
16. History of clear interstitial lung disease or non-infectious pneumonia, unless induced by local radiotherapy; Presence of active tuberculosis during screening period or previous anti-tuberculosis treatment within one year prior to randomization.
17. Any serious acute and chronic infection requiring systemic antibacterial, antifungal or antiviral therapy at screening, not including viral hepatitis.
18. Known history of human immunodeficiency virus (HIV) infection.
19. Previously receiving allogeneic stem cell or solid organ transplantation.
20. Inability to swallow tablets, malabsorption syndrome or any condition that affects gastrointestinal absorption.
21. Known history of serious allergy to any monoclonal antibody, targeted anti- angiogenic drug.
22. Other unsuitable subjects as per the investigators.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical college
Bengbu, Anhui, China
Anhui Cancer Hospital
Hefei, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
China PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Army Medical Center of PLA
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Southwest Hospital Of AMU
Chongqing, Chongqing Municipality, China
The Frist Hospital of Lanzhou University
Lanzhou, Gansu, China
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, China
The First Peoples Hospital of Foshan
Foshan, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
SSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
he First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
NanJing Drum Tower Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The first Affiliated hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Jilin Guowen Hospital
Changchun, Jilin, China
Liaoning cancer hospital
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, China
Xi'an International Medical Center Hospital
Xi’an, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Kaohsiung Medical University Chung-Ho Memorial Hospital
Gaoxiong, Taiwan, China
MacKay Memorial Hospital
Taibei, Taiwan, China
Changhua Christian Hospital
Zhanghua, Taiwan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
ShuLan（HangZhou) Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
ZheJiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Tongji Hospital Tongji Medical College Of HUST
Wuhan, Zhejiang, China
Xiehe Hospital Tongji Medical College Of HUST
Wuhan, Zhejiang, China
Zhongnan Hospital of Wuhan University
Wuhan, Zhejiang, China
Jia Fan
Shanghai, , China
Curie Oncology
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Countries
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References
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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.
Other Identifiers
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JS001-035-III-HCC
Identifier Type: -
Identifier Source: org_study_id
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