A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) Versus Camrelizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
NCT ID: NCT05367687
Last Updated: 2025-11-17
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
251 participants
INTERVENTIONAL
2022-09-01
2024-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT04639180
A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)
NCT04985136
Camrelizumab Combined With Apatinib for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma
NCT04701060
A Study of Camrelizumab Plus Apatinib as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Radical Resection or Ablation
NCT06546280
Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC
NCT07267806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group
Camrelizumab Plus Rivoceranib (Apatinib)
Camrelizumab、Rivoceranib
Camrelizumab: 200 mg, intravenous infusion. Rivoceranib: 250 mg, oral.
Control group
Camrelizumab
Camrelizumab
Camrelizumab: 200 mg, intravenous infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Camrelizumab、Rivoceranib
Camrelizumab: 200 mg, intravenous infusion. Rivoceranib: 250 mg, oral.
Camrelizumab
Camrelizumab: 200 mg, intravenous infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subjects who have undergone a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only).
3. No previous systematic treatment and locoregional therapy for HCC prior to randomization.
4. Absence of major macrovascular invasion.
5. No extrahepatic spread.
6. Full recovery from Curative resection or ablation within 4 weeks prior to randomization.
7. High risk for HCC recurrence after resection or ablation.
8. For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization.
9. Child-Pugh Class: Grade A.
10. ECOG-PS score: 0 or 1.
11. Subjects with HCV- RNA (+) must receive antiviral therapy.
12. Adequate organ function.
Exclusion Criteria
2. Evidence of residual lesion, recurrence, and metastasis at randomization.
3. Moderate-to-severe ascites with clinical symptoms.
4. History of hepatic encephalopathy.
5. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage.
6. Active or history of autoimmune disease.
7. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
8. Cardiac clinical symptom or cardiovascular disease that is not well controlled.
9. Severe infection within 4 weeks prior to the start of study treatment.
10. Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy.
11. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
12. Known genetic or acquired hemorrhage or thrombotic tendency.
13. Previous or current presence of metastasis to central nervous system.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SHR-1210-II-218
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.