Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC
Reason given: The PI has initiated a global multicenter Phase II clinical trial in the same direction, conducted by Akesobio.
Key facts
- Where
- Guangzhou and Shanghai, ChinaSee the 3 sites
- Phase
- Phase 2
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- Eastern Hepatobiliary Surgery HospitalShanghai, ChinaNo longer taking part
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaNo longer taking part
Trial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT06361758
- Record updated
- 23 May 2025
- Original description
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.Read full original descriptionShow less
Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC: A Single Arm, Multicenter, Phase II Trial. (SCALE)
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.
Inclusion: 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: Other anti-tumor therapies have been received after first-line systemic anti-tumor therapy; Previous bleeding from esophageal or fundus varices due to portal hypertension occurred within 6 months; Have history of hepatic encephalopathy, or a history of liver transplantation; 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; Autoimmune immune disease; HIV infection; 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; Fibrolamellar sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma; There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion; Central nervous system metastasis; Pregnant women.