Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC

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Fudan University

Status and phase

Begins enrollment this month
Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Cadonilimab+Lenvatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT06361758
B2023-326(2)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Cadonilimab+Lenvatinib
Experimental group
Treatment:
Drug: Cadonilimab+Lenvatinib

Trial contacts and locations

3

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Central trial contact

Xiaodong Zhu; Huichuan Sun

Data sourced from clinicaltrials.gov

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