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

NCT06280105 | Recruiting Phase 2

• 1 other identifier: 2023_148_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

cadonilimab (anti PD-1/CTLA-4 bispecific antibody)

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR) per RECIST1.1

  The proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.

  Up to two years

Secondary Outcomes (4)

• Progression-free survival（PFS）

  Up to two years

• Overall survival（OS）

  Up to three years

• Duration of response (DOR)

  Up to two years

• Occurence of AE and SAE

  Up to two years

Study Arms (1)

cadonilimab+regorafenib

EXPERIMENTAL

Drug: Cadonilimab+regorafenib

Interventions

Cadonilimab+regorafenib DRUG

cadonilimab: 6mg/kg iv D1 Q2W; regorafenib: 80mg QD oral; Eligible patients will receive cadonilimab combined with regorafenib, until disease progression or intolerable toxicity or death or withdrawal of informed consent, whichever occurred first

cadonilimab+regorafenib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meng Chao Hepatobiliary Hospital of Fujian Medical University: lead

Study Sites (1)

Mengchao Hepatobiliary Hospital, Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: March 31, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)