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

Shen Feng

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma

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

Study type: Observational

Funder types: Other

Identifiers

NCT06699524

EHBH-202408

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

122 participants in 2 patient groups

drug-sensitive group

Description:

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。

Treatment:

Drug: in vitro （chemotherapy）

Device: Adjuvant TACE（Adjuvant Transarterial Chemoembolization）

drug-resistant group

Description:

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。

Treatment:

Drug: in vitro （chemotherapy）

Device: Adjuvant TACE（Adjuvant Transarterial Chemoembolization）