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NCT06699524Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
122 (estimated)
First submitted
19 Nov 2024
Start date
20 Sept 2022
Primary completion date
20 Sept 2024
Lead sponsor
Shen Feng
NCT number
NCT06699524

What you commit to

  • Study type: Observational
  • Planned participants: 122
  • From 20 Sept 2022 to the primary completion date, 20 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 17 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Eastern Hepatobiliary Surgery Hospital, Naval Medical University,
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.