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


Hepatocellular Carcinoma


Drug: Cadonilimab+Lenvatinib

Study type


Funder types




Details and patient eligibility


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.


30 estimated patients




18 to 75 years old


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




Interventional model

Single Group Assignment


None (Open label)

30 participants in 1 patient group

Experimental group
Drug: Cadonilimab+Lenvatinib

Trial contacts and locations



Central trial contact

Xiaodong Zhu; Huichuan Sun

Data sourced from

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