Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Conditions
Brief summary
A Trial to Evaluate the Efficacy and Safety of 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.
Interventions
DRUGCamrelizumab、Rivoceranib
Camrelizumab: 200 mg, intravenous infusion. Rivoceranib: 250 mg, oral.
DRUGCamrelizumab
Camrelizumab: 200 mg, intravenous infusion.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Camrelizumab Plus Rivoceranib (Apatinib) compared with Camrelizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with a histopathological diagnosis of HCC. 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
1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS), as Determined by the investigator | 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 the investigator, or death from any cause (whichever occurs first). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Randomization up to approximately 43 months | — |
Countries
China
Outcome results
None listed