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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

Treatments: Drug: Camrelizumab、Rivoceranib; Drug: Camrelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05367687

SHR-1210-II-218

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

251 participants in 2 patient groups

Treatment group

Experimental group

Description:

Camrelizumab Plus Rivoceranib (Apatinib)

Treatment:

Drug: Camrelizumab、Rivoceranib

Control group

Active Comparator group

Description:

Camrelizumab

Treatment:

Drug: Camrelizumab