Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:24 PM
Study NCT ID:
NCT07363356
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer
Sponsor:
Eastern Hepatobiliary Surgery Hospital
Organization:
Study Overview
Official Title:
Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer: A Prospective, Non-Randomized，Open-Label, Phase II Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center, prospective, non-randomized, open-label, phase II clinical trial aiming to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized adjuvant therapy in patients with primary liver cancer (HCC) following curative liver resection. A total of 56 eligible patients will be enrolled. Tumor tissues obtained during surgery will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved targeted and immunotherapeutic agents (including Apatinib, Atezolizumab + Bevacizumab, Donafenib + Toripalimab, Sintilimab, and FOLFOX) to identify the most effective treatment for each patient. Patients for whom organoid testing fails or results are unavailable within the specified timeframe will receive standard Lenvatinib treatment. The primary endpoint is Recurrence-Free Survival (RFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel strategy for personalized adjuvant therapy in HCC to improve patient outcomes.
Detailed Description:
1. Study Design:
This is a single-center, prospective, non-randomized, open-label, phase II clinical trial conducted at the Third Affiliated Hospital of Naval Medical University. The study aims to validate the clinical utility of tumor organoid drug sensitivity testing in personalizing adjuvant therapy for hepatocellular carcinoma (HCC) after curative liver resection.
2. Study Population:
The study will enroll 56 adult patients (aged 18-70) with primary HCC who have undergone curative liver resection and are at high risk of recurrence (e.g., tumor diameter \>5 cm, multiple tumors, microvascular invasion, poor differentiation). Participants must have adequate organ function, an ECOG performance status of 0-1, and a life expectancy of \>6 months.
3. Interventions:
Organoid Drug Sensitivity Testing (ODST) Group: 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 (Apatinib, Atezolizumab+Bevacizumab, Donafenib+Toripalimab, Sintilimab, FOLFOX). The most effective drug(s), based on IC50 and AUC values, are recommended for adjuvant therapy.
Control Group (Empirical Treatment): Patients for whom organoid construction fails, or valid drug sensitivity results are not available within 1 month, receive standard Lenvatinib treatment.
4. Study Endpoints:
Primary Endpoint: Recurrence-Free Survival (RFS), defined as the time from treatment initiation to tumor recurrence.
Secondary Endpoints:
Overall Survival (OS)
Safety and tolerability, assessed by the incidence and severity of adverse events (AEs, SAEs) according to NCI CTCAE v5.0.
5. Follow-up:
Patients will be followed regularly with imaging (every 42±3 days initially, then every 3 months for the first year, and every 6 months thereafter) and laboratory assessments to monitor for recurrence and adverse events until death, withdrawal of consent, or study termination.
6. Statistical Analysis:
Sample size was calculated based on an assumed improvement in median RFS from 11.0 months (empirical group) to 33.0 months (ODST-guided group) (α=0.05, power=80%, 1:1 allocation, 10% dropout rate). Statistical analyses will be performed using SAS, with descriptive statistics for safety and efficacy analyses.
This is a single-center, prospective, non-randomized, open-label, phase II clinical trial conducted at the Third Affiliated Hospital of Naval Medical University. The study aims to validate the clinical utility of tumor organoid drug sensitivity testing in personalizing adjuvant therapy for hepatocellular carcinoma (HCC) after curative liver resection.
2. Study Population:
The study will enroll 56 adult patients (aged 18-70) with primary HCC who have undergone curative liver resection and are at high risk of recurrence (e.g., tumor diameter \>5 cm, multiple tumors, microvascular invasion, poor differentiation). Participants must have adequate organ function, an ECOG performance status of 0-1, and a life expectancy of \>6 months.
3. Interventions:
Organoid Drug Sensitivity Testing (ODST) Group: 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 (Apatinib, Atezolizumab+Bevacizumab, Donafenib+Toripalimab, Sintilimab, FOLFOX). The most effective drug(s), based on IC50 and AUC values, are recommended for adjuvant therapy.
Control Group (Empirical Treatment): Patients for whom organoid construction fails, or valid drug sensitivity results are not available within 1 month, receive standard Lenvatinib treatment.
4. Study Endpoints:
Primary Endpoint: Recurrence-Free Survival (RFS), defined as the time from treatment initiation to tumor recurrence.
Secondary Endpoints:
Overall Survival (OS)
Safety and tolerability, assessed by the incidence and severity of adverse events (AEs, SAEs) according to NCI CTCAE v5.0.
5. Follow-up:
Patients will be followed regularly with imaging (every 42±3 days initially, then every 3 months for the first year, and every 6 months thereafter) and laboratory assessments to monitor for recurrence and adverse events until death, withdrawal of consent, or study termination.
6. Statistical Analysis:
Sample size was calculated based on an assumed improvement in median RFS from 11.0 months (empirical group) to 33.0 months (ODST-guided group) (α=0.05, power=80%, 1:1 allocation, 10% dropout rate). Statistical analyses will be performed using SAS, with descriptive statistics for safety and efficacy analyses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: