Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07351513
PHASE2

A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma

Sponsor: Eastern Hepatobiliary Surgery Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (DST) to guide personalized systemic therapy for patients with unresectable hepatocellular carcinoma (HCC). A total of 94 eligible patients will be enrolled and grouped based on patient preference into either the Organoid-Directed Therapy group or the Control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a pre-defined panel of approved regimens (including Atezolizumab + Bevacizumab, Sintilimab + Bevacizumab biosimilar, Apatinib + Camrelizumab, Donafenib, Lenvatinib, Tislelizumab, Sorafenib, and FOLFOX4) to identify the most effective treatment. Patients for whom organoid construction fails or valid DST results are unavailable within one month will cross over to the control group to receive standard therapy. The co-primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS), both assessed according to RECIST 1.1. Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced, unresectable HCC.

Official title: Patient-Derived Tumor Organoid Drug Sensitivity Testing to Guide Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma: A Prospective, Non-randomized, Open-label, Single-Center Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2026-01-30

Completion Date

2028-12-31

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

Organoid Drug Sensitivity Testing-Guided Therapy

Fresh tumor tissue from resection is used to establish and culture patient-derived organoids. Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Atezolizumab + Bevacizumab, Sintilimab + Bevacizumab Biosimilar,Apatinib+ Camrelizumab, Donafenib, Lenvatinib, Tislelizumab, Sorafenib, FOLFOX4). The most effective drug(s), based on IC50 and AUC values, are recommended for treatment.