Immunotherapy combo aims to outperform standard care in advanced liver cancer

NCT ID NCT04723004

Disease control Sponsor: Shanghai Junshi Bioscience Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This phase 3 trial compares a combination of two drugs—toripalimab (an immunotherapy) and bevacizumab (an anti-angiogenic agent)—against the standard drug sorafenib as the first treatment for people with advanced liver cancer that cannot be surgically removed. The study enrolls adults aged 18–75 who have not received prior systemic therapy. Researchers are measuring how long participants live without their cancer worsening and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: toripalimab combined with bevacizumab
What this could lead to: If successful, this combination could become a new first-line treatment option for advanced liver cancer, potentially improving survival and delaying disease progression.
What could go wrong: This is an early-phase trial with a limited number of participants. The combination may not prove superior to sorafenib, and side effects from immunotherapy and anti-angiogenic drugs can be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

326 people

The number who actually took part.

Started

Oct 2020

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age of 18-75 years (inclusive), male or female. 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： 1. Known ICC or mixed cell carcinoma, sarcomatoid HCC and hepatic fibrolamellar carcinoma. 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.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced hepatocellular carcinoma (HCC)

Contacts and locations

Locations

Anhui Cancer Hospital

Hefei, Anhui, 230000, China
Anhui Provincial Hospital

Hefei, Anhui, 230000, China
Army Medical Center of PLA

Chongqing, Chongqing Municipality, 400000, China
Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China
Changhua Christian Hospital

Zhanghua, Taiwan, 000500, China
China PLA General Hospital

Beijing, Beijing Municipality, 100000, China
Curie Oncology

Singapore, Singapore, 999002, Singapore
First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, 710000, China
Gansu Wuwei Tumor Hospital

Wuwei, Gansu, 733000, China
Hainan General Hospital

Haikou, Hainan, 570100, China
Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China
Henan Provincial Cancer Hospital

Zhengzhou, Henan, 450000, China
Hubei Cancer Hospital

Wuhan, Hubei, 430000, China
Hunan Cancer Hospital

Changsha, Hunan, 410000, China
Jia Fan

Shanghai, 130061, China
Jilin Cancer Hospital

Changchun, Jilin, 130000, China
Jilin Guowen Hospital

Changchun, Jilin, 130000, China
Kaohsiung Medical University Chung-Ho Memorial Hospital

Gaoxiong, Taiwan, 000800, China
Liaoning cancer hospital

Shenyang, Liaoning, 110000, China
MacKay Memorial Hospital

Taibei, Taiwan, 100, China
NanJing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China
Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China
Nantong Tumor Hospital

Nantong, Jiangsu, 226000, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China
SSun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China
Shandong Cancer Hospital

Jinan, Shandong, 250000, China
ShuLan（HangZhou) Hospital

Hangzhou, Zhejiang, 310000, China
Sichuan Cancer Hospital

Chengdu, Sichuan, 610000, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China
Tan Tock Seng Hospital

Singapore, Singapore, 999002, Singapore
The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China
The First Affiliated Hospital of Bengbu Medical college

Bengbu, Anhui, 233000, China
The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China
The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China
The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China
The First Peoples Hospital of Foshan

Foshan, Guangdong, 528000, China
The Frist Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China
The Second Affiliated hospital of Nanchang University

Nanchang, Jiangxi, 330000, China
The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China
The Southwest Hospital Of AMU

Chongqing, Chongqing Municipality, 400000, China
The first Affiliated hospital of Nanchang University

Nanchang, Jiangxi, 330000, China
Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China
Tongji Hospital Tongji Medical College Of HUST

Wuhan, Zhejiang, 430000, China
West China Hospital，Sichuan University

Chengdu, Sichuan, 610000, China
Xi'an International Medical Center Hospital

Xi’an, Shanxi, 710000, China
Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China
Xiehe Hospital Tongji Medical College Of HUST

Wuhan, Zhejiang, 430000, China
Yuebei People's Hospital

Shaoguan, Guangdong, 512000, China
Yunnan Cancer Hospital

Kunming, Yunnan, 650000, China
ZheJiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China
ZheJiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China
Zhongnan Hospital of Wuhan University

Wuhan, Zhejiang, 430000, China
he First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

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