A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
NCT ID: NCT04639180
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
687 participants
INTERVENTIONAL
2021-04-01
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))
Drug: Camrelizumab; Drug: Rivoceranib (Apatinib)
Camrelizumab
Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
Rivoceranib (Apatinib)
Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet
Control group (Active surveillance)
No interventions assigned to this group
Interventions
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Camrelizumab
Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
Rivoceranib (Apatinib)
Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet
Eligibility Criteria
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Inclusion Criteria
* Subjects who have undergone a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only)
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread
* Full recovery from Curative resection or ablation within 4 weeks prior to randomization
* High risk for HCC recurrence after resection or ablation
* For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
* Child-Pugh Class: Grade A
* ECOG-PS score: 0 or 1
* Subjects with HCV- RNA (+) must receive antiviral therapy
* Adequate organ function
Exclusion Criteria
* Evidence of residual lesion, recurrence, and metastasis at randomization;
* Moderate-to-severe ascites with clinical symptoms
* History of hepatic encephalopathy
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage
* Active or history of autoimmune disease
* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
* Cardiac clinical symptom or cardiovascular disease that is not well controlled
* Severe infection within 4 weeks prior to the start of study treatment
* HIV infection
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Serious non-healing or dehiscing wound
* Major Curative procedure within four weeks
* Factors to affect oral administration
* Previous or current presence of metastasis to central nervous system
18 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangxi Medical University Affiliated Tumor Hospital
Nanjin, Guangzhou, China
Guizhou Cancer Hospital
Guiyang, Guizhou, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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SHR-1210-III-325
Identifier Type: -
Identifier Source: org_study_id