Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC

NCT ID: NCT06361758

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2027-05-31

Brief Summary

This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cadonilimab+Lenvatinib

Group Type: EXPERIMENTAL

Cadonilimab+Lenvatinib

Intervention Type: DRUG

Cadonilimab (AK104): 15mg/kg Q3W iv D1 + Lenvatinib: 8 mg (body weight \<60 kg) or 12mg (body weight ≥60 kg) orally QD. Eligible patients will receive AK104 plus Lenvatinib until disease progression or withdrawn ICF or death, whichever comes first.

Interventions

Cadonilimab+Lenvatinib

Cadonilimab (AK104): 15mg/kg Q3W iv D1 + Lenvatinib: 8 mg (body weight \<60 kg) or 12mg (body weight ≥60 kg) orally QD. Eligible patients will receive AK104 plus Lenvatinib until disease progression or withdrawn ICF or death, whichever comes first.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
• Age 18-75 years old, Male of Female
• ECOG PS 0-1
• histologically/cytologically or clinically (according to Chinese guidelines for primary liver cancer diagnosis and treatment (2022) criteria) confirmed initial diagnosis of HCC
• Not suitable for radical surgery and/or local treatment, BCLC stage C or stage B who failed local treatment
• Patients who progressed on first-line standard system therapy (Atezolizumab plus bevacizumab, sintilimab combined with bevacizumab, or Camrelizumab and Apatinib, only these three regimenes) or with intolerable toxicity ( except for immunotherapy intolerance)
• Child Pugh A-B7
• Expected survival time≥12 weeks
• At least one measurable lesion (RECIST 1.1)
• Enough organ and bone marrow function

Exclusion Criteria

• Fibrolamellar sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma.
• Other anti-tumor therapies have been received after first-line systemic anti-tumor therapy.
• Have history of hepatic encephalopathy, or a history of liver transplantation.
• There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion.
• People with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA > 2000IU/ml or 10^4 copies /ml; Hepatitis C virus (HCV) RNA > 10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive.
• Central nervous system metastasis.
• Previous bleeding from esophageal or fundus varices due to portal hypertension occurred within 6 months.
• Autoimmune immune disease.
• HIV infection.
• Pregnant women.
• The presence of any serious or uncontrolled systemic disease.
• Other acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the following results: increasing the risk associated with research or drug administration, or interfering with the interpretation of research results. The Investigator considers that there are other potential risks that are not suitable for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hui-Chuan Sun

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huichuan Sun

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Sun Yat-sen University Cancer Center)

Guangzhou, , China

Eastern Hepatobiliary Surgery Hospital

Shanghai, , China

Countries

China

Other Identifiers

B2023-326(2)

Identifier Type: -

Identifier Source: org_study_id