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Clinical Trials in China / NCT06699524
Active, not recruiting Observational

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

NCT06699524 · tracked via the Priya Life Science China tracker
Sponsor
Shen Feng
Phase
Observational
Started
2022-09-20
Last updated
2024-11-21

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

in vitro (chemotherapy)Adjuvant TACE(Adjuvant Transarterial Chemoembolization)

in vitro (chemotherapy): 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.

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

Study 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.

Eligibility

Sex
ALL
Min age
17 Years
Max age
70 Years
Healthy volunteers
No
The inclusion criteria were as follows: (1) age between 18 and 80 years; (2) postoperative pathological diagnosis of HCC; (3) adjuvant TACE performed 4-8 weeks after radical surgical resection; and (4) successful culture of PDTO, with sufficient quantity for drug testing. The exclusion criteria were as follows: (1) patients with an American Society of Anesthesiologists (ASA) score greater than 3; (2) failure or contamination of PDTO culture; (3) failure to complete standardized adjuvant TACE treatment postoperatively; and (4) patients who received neoadjuvant or other adjuvant therapies, including radiotherapy and systemic treatments.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai Shanghai Municipality

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06699524 on ClinicalTrials.gov ↗ ← All trials in China