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

NCT06699524 | Active Not Recruiting DMC FDA Drug FDA Device

• 1 other identifier: EHBH-202408
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

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

  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

Study Arms (2)

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。

Drug: in vitro （chemotherapy）; Device: 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。

Drug: in vitro （chemotherapy）; Device: Adjuvant TACE（Adjuvant Transarterial Chemoembolization）

Interventions

in vitro （chemotherapy） DRUG

resuscitating PDTO from the organoid biobank, patients were categorized into drug-sensitive and drug-resistant groups based on the optimal cutoff value for PDTO drug testing. We then followed up to analyze the correlation between PDTO drug testing and RFS.

drug-resistant group; drug-sensitive group

Adjuvant TACE（Adjuvant Transarterial Chemoembolization） DEVICE

Adjuvant TACE was performed 4 to 8 weeks postoperatively, with a chemotherapy regimen of 50 mg of doxorubicin and 50 mg of oxaliplatin.

drug-resistant group; drug-sensitive group

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included samples collected from the organoid biobank of the Eastern Hepatobiliary Surgery Hospital between September 2019 and September 2022.

Sponsors & Collaborators

• Shen Feng: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital, Naval Medical University,

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dean of Clinical Research Institute, Director of Four Departments of Hepatology, Chief Physician, Professor

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: September 20, 2022
• Primary Completion: September 20, 2024
• Study Completion: December 20, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

CN (1)