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

Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

A Randomized, Open-Label, Multi-Center, Phase Ⅲ Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04639180
• Other study ID #: SHR-1210-III-325
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 687
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• HIV infection
• Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
• 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
• Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
• Serious non-healing or dehiscing wound
• Major Curative procedure within four weeks
• Factors to affect oral administration
• Previous or current presence of metastasis to central nervous system

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma (HCC)
• Recurrence

Intervention

Drug:
• Camrelizumab
Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
• Rivoceranib (Apatinib)
Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Guizhou Cancer Hospital	Guiyang	Guizhou
China	Guangxi Medical University Affiliated Tumor Hospital	Nanjin	Guangzhou
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)	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).	Randomization up to approximately 43 months
Secondary	RFS Rate at 24 and 36 Months, as Assessed by the Investigator		Randomization up to 24 months and up to 36 months
Secondary	Time to Recurrence (TTR) as determined by the investigator and by BIRC	TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC	Randomization up to approximately 43 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death from any cause	Randomization up to approximately 43 months
Secondary	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