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
Study Details
Study Description
Brief Summary
A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group (Camrelizumab Plus Rivoceranib (Apatinib)) Drug: Camrelizumab; Drug: Rivoceranib (Apatinib) |
Drug: Camrelizumab
Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
Drug: Rivoceranib (Apatinib)
Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet
|
| No Intervention: Control group (Active surveillance)
|
Outcome Measures
Primary Outcome Measures
- Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC) [Randomization up to approximately 43 months]
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Secondary Outcome Measures
- RFS Rate at 24 and 36 Months, as Assessed by the Investigator [Randomization up to 24 months and up to 36 months]
- Time to Recurrence (TTR) as determined by the investigator and by BIRC [Randomization up to approximately 43 months]
TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC
- Overall Survival (OS) [Randomization up to approximately 43 months]
OS is defined as the time from randomization to death from any cause
- The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 [Baseline up to approximately 43 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects with a histopathological diagnosis of HCC
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Subjects who have undergone a curative resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only)
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No previous systematic treatment and locoregional therapy for HCC prior to randomization
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Absence of major macrovascular invasion
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No extrahepatic spread
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Full recovery from Curative resection or ablation within 4 weeks prior to randomization
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High risk for HCC recurrence after resection or ablation
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For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
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Child-Pugh Class: Grade A
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ECOG-PS score: 0 or 1
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Subjects with HCV- RNA (+) must receive antiviral therapy
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Adequate organ function
Exclusion Criteria:
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Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously
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Evidence of residual lesion, recurrence, and metastasis at randomization;
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Moderate-to-severe ascites with clinical symptoms
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History of hepatic encephalopathy
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History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage
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Active or history of autoimmune disease
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Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
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Cardiac clinical symptom or cardiovascular disease that is not well controlled
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Severe infection within 4 weeks prior to the start of study treatment
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HIV infection
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Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
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Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
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Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
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Known genetic or acquired hemorrhage or thrombotic tendency
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Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
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Serious non-healing or dehiscing wound
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Major Curative procedure within four weeks
-
Factors to affect oral administration
-
Previous or current presence of metastasis to central nervous system
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing | China | |
| 2 | Guangxi Medical University Affiliated Tumor Hospital | Nanjin | Guangzhou | China | |
| 3 | Guizhou Cancer Hospital | Guiyang | Guizhou | China | |
| 4 | Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai | China | |
| 5 | Zhongshan Hospital, Fudan University | Shanghai | Shanghai | China | |
| 6 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1210-III-325