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

NCT05367687 | Completed Phase 2

• 1 other identifier: SHR-1210-II-218
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Recurrence-Free Survival (RFS), as Determined by the investigator

  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).

  Randomization up to approximately 43 months

Secondary Outcomes (4)

• 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

• Overall Survival (OS)

  Randomization up to approximately 43 months

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

Camrelizumab Plus Rivoceranib (Apatinib)

Drug: Camrelizumab、Rivoceranib

Control group

ACTIVE COMPARATOR

Camrelizumab

Drug: Camrelizumab

Interventions

Camrelizumab、Rivoceranib DRUG

Camrelizumab: 200 mg, intravenous infusion. Rivoceranib: 250 mg, oral.

Treatment group

Camrelizumab DRUG

Camrelizumab: 200 mg, intravenous infusion.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a histopathological diagnosis of HCC.
• 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.

You may not qualify if:

• Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously.
• 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.
• 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.
• Previous or current presence of metastasis to central nervous system.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

camrelizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Camrelizumab Plus Rivoceranib (Apatinib) compared with Camrelizumab
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: September 1, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)