Clinical trial NCT06361758: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC
Official title: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC: A Single Arm, Multicenter, Phase II Trial. (SCALE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: cadonilimab (anti PD-1/CTLA-4 bispecific antibody)
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Eastern Hepatobiliary Surgery Hospital
First posted: 2024-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR) per RECIST v1.1
timeFrame: Up to two years
Secondary outcomes:
measure: Objective Response Rate (ORR) per mRECIST
timeFrame: Up to two years
measure: Disease control Rate (DCR)
timeFrame: Up to two years
measure: Duration of response (DoR)
timeFrame: Up to two years
measure: Progression-Free-Survival (PFS)
timeFrame: Up to two years
measure: Overall survival Overall survival (OS)
timeFrame: Up to three years
measure: Incidence of Adverse Events
timeFrame: Up to two years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center)
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
Study officials:
affiliation: Study Principal Investigator
name: Huichuan Sun
role: PRINCIPAL_INVESTIGATOR
References: