Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC

Trial Title: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC

NCT ID: NCT06361758

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma, Hepatocellular
Lenvatinib

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

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cadonilimab+Lenvatinib
Description: 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 Eligible patients will receive AK104 plus Lenvatinib until disease progression or withdrawn ICF or death, whichever comes first.
Arm group label: Cadonilimab+Lenvatinib

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhongshan Hospital, Fudan University

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: Sun Yat-sen University Cancer Center)

Address:
City: Guangzhou
Country: China

Contact:
Last name: Li Xu

Investigator:
Last name: Li Xu
Email: Principal Investigator

Facility:
Name: Eastern Hepatobiliary Surgery Hospital

Address:
City: Shanghai
Country: China

Contact:
Last name: Kui Wang

Contact backup:
Last name: Jun Xue

Investigator:
Last name: Kui Wang
Email: Principal Investigator

Start date: May 31, 2024

Completion date: May 31, 2027

Lead sponsor:
Agency: Shanghai Zhongshan Hospital
Agency class: Other

Collaborator:
Agency: Sun Yat-sen University
Agency class: Other

Collaborator:
Agency: Eastern Hepatobiliary Surgery Hospital
Agency class: Other

Source: Shanghai Zhongshan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06361758