Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06280105

A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib

Led by Meng Chao Hepatobiliary Hospital of Fujian Medical University · Updated on 2025-05-15

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib.

CONDITIONS

Official Title

A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed a written informed consent form before enrollment
  • Age over 18 years, any sex
  • Histologically or pathologically confirmed intermediate or advanced hepatocellular carcinoma, or cirrhosis patients meeting American Association for the Study of Liver Diseases clinical criteria
  • Disease progressed on camrelizumab plus apatinib treatment
  • Child-Pugh Class A liver function
  • Eastern Cooperative Oncology Group performance status score of 0 to 1
  • At least one measurable lesion according to RECIST 1.1
  • Expected survival of at least 12 weeks
  • Adequate vital organ function with specified blood counts and liver/kidney function limits
  • Normal coagulation function without active bleeding or thrombosis
  • Non-surgical sterilization or female patients of childbearing potential
  • Willingness to voluntarily participate and comply with safety and survival follow-up
Not Eligible

You will not qualify if you...

  • Presence of fibrolamellar, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma
  • History of hepatic encephalopathy
  • History of liver transplantation
  • Significant pericardial or pleural effusion requiring drainage
  • Clinically apparent ascites detected or requiring drainage
  • Simultaneous infection with HBV and HCV (except resolved HCV infection)
  • Central nervous system or meningeal metastasis
  • Bleeding from esophageal or gastric varices within 6 months before treatment
  • Bleeding events grade 3 or higher within 4 weeks before treatment
  • Arterial or venous thromboembolic events within 6 months before treatment
  • Uncontrolled high blood pressure
  • Symptomatic congestive heart failure
  • Severe bleeding tendencies or coagulation disorders
  • History of gastrointestinal perforation, fistula, or intestinal obstruction within 6 months before treatment
  • Active or history of autoimmune disease
  • HIV infection
  • Other serious illnesses endangering safety or study completion as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mengchao Hepatobiliary Hospital, Fujian Medical University

Fuzhou, Fujian, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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