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Clinical Trials/NCT06699524
NCT06699524
Active, not recruiting
Not Applicable

Construction of a Recurrence Risk Prediction Model for Liver Resection Based on Drug Sensitivity of Patient-derived Liver Cancer Organoid

Shen Feng1 site in 1 country122 target enrollmentSeptember 20, 2022

Overview

Phase
Not Applicable
Intervention
in vitro (chemotherapy)
Conditions
Hepatocellular Carcinoma
Sponsor
Shen Feng
Enrollment
122
Locations
1
Primary Endpoint
Recurrence free survival
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Liver cancer is the sixth most common malignant tumor worldwide and the third leading cause of cancer-related deaths. China is a high-risk area for liver cancer, accounting for approximately 55% of primary liver cancer worldwide. Liver cancer is highly malignant and easy to recur, which seriously endangers the life and health of our people. Hepatectomy is the preferred treatment for liver cancer, but the 5-year recurrence rate remains as high as 70%, severely limiting the effectiveness of the surgery. Therefore, exploring the risk factors and predictive methods for early tumor recurrence after liver resection in patients has high clinical value. Clinical practice has found that primary liver cancer patients can be treated with postoperative adjuvant transarterial chemoembolization (TACE) to prevent recurrence. However, the effectiveness of TACE varies among patients and may be related to tumor heterogeneity. However, many studies have reported that drug sensitivity testing based on patient derived organoids can indicate the clinical efficacy of drugs, but there is currently no relevant research indicating that organoids can reflect the therapeutic response of TACE. Therefore, the aim of this study is to explore the correlation between patient derived organoid drug sensitivity testing results and TACE treatment responsiveness and tumor recurrence, and further construct a column chart model to predict tumor recurrence after adjuvant TACE.

Registry
clinicaltrials.gov
Start Date
September 20, 2022
End Date
December 20, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Shen Feng
Responsible Party
Sponsor Investigator
Principal Investigator

Shen Feng

Dean of Clinical Research Institute, Director of Four Departments of Hepatology, Chief Physician, Professor

Eastern Hepatobiliary Surgery Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

drug-sensitive group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and \< 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

Intervention: in vitro (chemotherapy)

drug-sensitive group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and \< 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

Intervention: Adjuvant TACE(Adjuvant Transarterial Chemoembolization)

drug-resistant group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and \< 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

Intervention: in vitro (chemotherapy)

drug-resistant group

Organoid resistance and sensitivity are indicated by an IC50 value ≥23.815 μmol/L and \< 23.815 μmol/L, respectively. According to the PDTO drug testing, 42 patients were classified into the drug-sensitive group, and 80 patients into the drug-resistant group。

Intervention: Adjuvant TACE(Adjuvant Transarterial Chemoembolization)

Outcomes

Primary Outcomes

Recurrence free survival

Time Frame: Follow-up was performed at least every 2 months during the first 6 months after adjuvant TACE, and every 3 months for the subsequent 18 months. The follow-up period ended in September 2024

Recurrence within two years post-surgery was classified as early recurrence.

Study Sites (1)

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