NCT06280105RecruitingPhase 2

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

A Single-arm, Multicenter, Phase II Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Progressed on Camrelizumab Combined With Apatinib

Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 40 (estimated)
First submitted: 19 Feb 2024
Start date: 31 Mar 2024
Primary completion date: 31 Mar 2026
Lead sponsor: Meng Chao Hepatobiliary Hospital of Fujian Medical University
Diseases: Liver and biliary tract cancer
NCT number: NCT06280105

What you commit to

Study type: Interventional · Phase 2
Planned participants: 40
From 31 Mar 2024 to the primary completion date, 31 Mar 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Sign a written informed consent form before enrollment;
Age \>18 years old, both sex;
Histological or pathological confirmed intermediate or advanced hepatocellular carcinoma, or patients with cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD);
Have progressed on the combination treatment of camrelizumab and apatinib for HCC
Child-Pugh Class A;
ECOG PS score: 0\~1;
At least 1 measurable lesion (RECIST1.1)
Expected survival period≥12 weeks
The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days):
- 1\. Blood routine: Neutrophils≥1.5×109/L Platelet count ≥75×109/L Hemoglobin ≥ 90g/L; 2. Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 10 times the upper limit of normal (ULN); urine protein \< 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that the protein must be ≤ 1g; 10. Normal coagulation function, no active bleeding or thrombosis disease
International normalized ratio INR≤1.5×ULN;
Partial thromboplastin time APTT≤1.5×ULN;
Prothrombin time PT≤1.5×ULN; 11. Non-surgical sterilization or female patients of childbearing age 12. Subjects voluntarily join this study, have good compliance, and cooperate with safety and survival follow-up
- Main Exclusion Criteria:
Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology;
Have a history of hepatic encephalopathy;
Have a history of liver transplantation;
There is clinically significant pericardial effusion, and there are clinical symptoms of pleural effusion that require drainage;
Clinically apparent ascites is defined as meeting the following criteria: ascites can be detected by physical examination during screening or ascites needs to be drained during screening;
Simultaneous infection with HBV and HCV (having a history of HCV infection but negative HCV RNA can be considered as not being infected with HCV);
Presence of central nervous system metastasis or meningeal metastasis
Bleeding from esophageal or gastric varices caused by portal hypertension has occurred within 6 months before the first dose
Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks before the first dose
Arterial and venous thromboembolic events occurred within 6 months before the first dose
Uncontrolled high blood pressure
Symptomatic congestive heart failure
Severe bleeding tendency or coagulation disorder
Have a history of gastrointestinal perforation and/or fistula, intestinal obstruction within 6 months before the first dose
Active autoimmune disease or a history of autoimmune disease
Patients with HIV
According to the investigator's judgment, patients with other serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Mengchao Hepatobiliary Hospital, Fujian Medical University Coordinator of this site? Confirm its status	Fuzhou	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.