A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatin... | NCT05367687

Studies
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

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Completed

Last Update Posted

Nov 17, 2025Actual

Enrollment

251Actual

Phase

Phase 2

Conditions

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

Interventions

Camrelizumab、Rivoceranib
Camrelizumab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Nov 15, 2024Actual

Completion Date

Nov 15, 2024Actual

First Submitted Date

May 6, 2022

First Submission Date that Met QC Criteria

May 6, 2022

First Posted Date

May 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

251Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Camrelizumab Plus Rivoceranib (Apatinib)	Drug: Camrelizumab、Rivoceranib
Control group	Active Comparator	Camrelizumab	Drug: Camrelizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Camrelizumab、Rivoceranib	Drug	Camrelizumab: 200 mg, intravenous infusion. Rivoceranib: 250 mg, oral.	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided