Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma

Sun Yat-sen University1 site in 1 country100 target enrollmentMarch 1, 2023

ConditionsImmune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular Carcinoma

InterventionsImmune checkpoint inhibitor

DrugsImmune checkpoint inhibitor

Overview

Phase: Not Applicable
Intervention: Immune checkpoint inhibitor
Conditions: Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 100
Locations: 1
Primary Endpoint: Overall Survival
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Non-intervention observation to evaluate the safety and efficacy of immune checkpoint inhibitors alone or combined with molecular targeted drugs / local interventional therapy in patients with advanced liver cancer, and to provide the best choice for the treatment of patients with advanced liver cancer in different stages.

Registry

clinicaltrials.gov

Start Date

March 1, 2023

End Date

September 1, 2025

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Ming Zhao

Chief physician

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Written informed consent must be obtained prior to any screening procedures.
•Cytohistological confirmation is required for diagnosis of HCC.
•Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer \[BCLC\] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
•At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.
•Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
•Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
•astern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤
•Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
•Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
•Hemoglobin \> 100g/L Absolute neutrophil count \>3.0 ×109/L Neutrophil count \> 1.5 ×109/L Platelet count ≥ 50.0 ×109/L Total bilirubin \< 51 μmol/L Alanine transaminase (ALT) and aminotransferase (AST) \< 5 x upper limit of normal Albumin \> 28 g/L Prothrombin time (PT)-international normalized ratio (INR) \< 2.3, or PT \< 6 seconds above control Serum creatinine \< 110 μmol/L

Exclusion Criteria

•Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
•Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity \> grade
•Any contraindications for Immune checkpoint inhibitor procedure
•Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
•Known severe atheromatosis.
•Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
•Patients with any other malignancies within the last 3 years before study start.
•History of HCC tumor rupture.
•Patients with severe encephalopathy. Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy.
•History of cardiac disease.