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

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: in vitro （chemotherapy）; Device: Adjuvant TACE（Adjuvant Transarterial Chemoembolization）

• Registration Number: NCT06699524
• Lead Sponsor: Shen Feng

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-20
• Primary Completion: 2024-09-20
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
drug-sensitive group	in vitro （chemotherapy）	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-sensitive group	Adjuvant TACE（Adjuvant Transarterial Chemoembolization）	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-resistant group	in vitro （chemotherapy）	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-resistant group	Adjuvant TACE（Adjuvant Transarterial Chemoembolization）	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。

Primary Outcome Measures

Name	Time	Method
Recurrence free survival	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.

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital, Naval Medical University,; 🇨🇳 Shanghai, Shanghai, China