We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    Rivoceranib | Phase 3
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04639180
Recruitment Status : Active, not recruiting
First Posted : November 20, 2020
Last Update Posted : April 25, 2023
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma (HCC) Drug: Camrelizumab Drug: Rivoceranib (Apatinib) Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 687 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Camrelizumab Combined with Rivoceranib (Apatinib) Versus Active Surveillance
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment group (Camrelizumab Plus Rivoceranib (Apatinib))
Drug: Camrelizumab; Drug: Rivoceranib (Apatinib)
 Drug: Camrelizumab
Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder

Drug: Rivoceranib (Apatinib)
Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet
No Intervention: Control group (Active surveillance)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC) [ Time Frame: 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 BIRC, or death from any cause (whichever occurs first).


Secondary Outcome Measures :
  1. RFS Rate at 24 and 36 Months, as Assessed by the Investigator [ Time Frame: Randomization up to 24 months and up to 36 months ]
  2. Time to Recurrence (TTR) as determined by the investigator and by BIRC [ Time Frame: Randomization up to approximately 43 months ]
    TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC

  3. Overall Survival (OS) [ Time Frame: Randomization up to approximately 43 months ]
    OS is defined as the time from randomization to death from any cause

  4. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 [ Time Frame: Baseline up to approximately 43 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639180


Locations
Layout table for location information
China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China
China, Guangzhou
Guangxi Medical University Affiliated Tumor Hospital
Nanjin, Guangzhou, China
China, Guizhou
Guizhou Cancer Hospital
Guiyang, Guizhou, China
China, Shanghai
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04639180    
Other Study ID Numbers: SHR-1210-III-325
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: April 25, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action