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

NCT07351513 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Principal Investigators

  • Feng Shen · Eastern Hepatobiliary Surgery Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2026-10-30
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07351513 on ClinicalTrials.gov