Back to resultsA 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
Primary Purpose
Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab、Rivoceranib
Camrelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
Eligibility Criteria
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.
- 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.
Sites / Locations
- Zhongshan Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
Camrelizumab Plus Rivoceranib (Apatinib)
Camrelizumab
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
Time to Recurrence (TTR) as determined by the investigator
TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC.
Overall Survival (OS)
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
Full Information
NCT ID
NCT05367687
First Posted
May 6, 2022
Last Updated
August 21, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05367687
Brief Title
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
Official Title
A Randomized, Open-Label, Multi-Center, Phase 2 Clinical Study 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Camrelizumab Plus Rivoceranib (Apatinib) compared with Camrelizumab
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Camrelizumab Plus Rivoceranib (Apatinib)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Camrelizumab
Intervention Type
Drug
Intervention Name(s)
Camrelizumab、Rivoceranib
Intervention Description
Camrelizumab: 200 mg, intravenous infusion. Rivoceranib: 250 mg, oral.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
Camrelizumab: 200 mg, intravenous infusion.
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS), as Determined by the investigator
Description
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).
Time Frame
Randomization up to approximately 43 months
Secondary Outcome Measure Information:
Title
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
Time Frame
Randomization up to 24 months and up to 36 months
Title
Time to Recurrence (TTR) as determined by the investigator
Description
TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC.
Time Frame
Randomization up to approximately 43 months
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Randomization up to approximately 43 months
Title
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time Frame
Randomization up to approximately 43 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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