A Study to Evaluate the Effects of Radiotherapy Combined With Tyrosine Kinase Inhibitor (TKI) and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma With Portal Vein Tumor Thrombus(PVTT)

Fujian Cancer Hospital1 site in 1 country22 target enrollmentJanuary 9, 2024

ConditionsStage IIIA Hepatocellular Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stage IIIA Hepatocellular Carcinoma
Sponsor: Fujian Cancer Hospital
Enrollment: 22
Locations: 1
Primary Endpoint: OS
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical research study is to investigate the efficacy and safety of Radiotherapy Combined with TKI and Anti-PD-1 Antibody for Stage IIIA Hepatocellular Carcinoma with Portal Vein Tumor Thrombus(PVTT).

Registry

clinicaltrials.gov

Start Date

January 9, 2024

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fujian Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with primary hepatocellular carcinoma who strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 edition) or who have been confirmed by histopathology or human cytology, There was at least one measurable lesion (spiral CT scan length ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard);
•Patients with advanced primary hepatocellular carcinoma who have not received systematic treatment and cannot be surgically resectable;
•CNLC was divided into stage IIIA, VP1-3 type;
•Child-Pugh classification of liver function is grade A (5-6 points);
•ECOG PS score 0-1;
•Expected survival ≥12 weeks;
•Patients with active hepatitis B virus (HBV) infection must be willing to receive antiviral treatment throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function within CTCAE level 1 elevation;
•The major organs function normally and meet the following criteria :
•The blood routine examination criteria should meet :(no blood transfusion within 14 days)
•Hemoglobin (HB)≥90g/L,

Exclusion Criteria

•Pregnant or lactating women;
•Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ);
•Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
•Patients with a history of epigastric radiotherapy;
•Patients who fail to follow dose limits for vital organs in the radiotherapy program, including patients with normal liver tissue less than 700 ml in the radiotherapy program;
•Patients who have participated in other clinical trials in the past three months;
•Previously received targeted therapy or other PD-1/PD-L1 inhibitor therapy;
•Received major surgery or chemotherapy, radiation therapy or other focal systemic therapy within 1 month before enrollment;
•Immunosuppressive agents or systemic hormone therapy (dose \>10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression;
•Liver function was classified as Child-Pugh C, which could not be improved by liver protection treatment.

Outcomes

Primary Outcomes

Time Frame: the date of first administration to the subject's death from various causes

Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.

ORR

Time Frame: The best efficacy recorded between the date of first administration and the date of objective recording of progress according to mRECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy, whichever occurs first

Assessed according to the modified Response Evaluation Criteria in Solid Tumors Version 1.1, undergoing enhanced CT/MRI.