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

NCT ID: NCT06699524

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2024-12-20

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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。

in vitro （chemotherapy）

Intervention Type: 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.

Adjuvant TACE（Adjuvant Transarterial Chemoembolization）

Intervention Type: 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

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。

in vitro （chemotherapy）

Intervention Type: 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.

Adjuvant TACE（Adjuvant Transarterial Chemoembolization）

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shen Feng

OTHER

Sponsor Role: lead

Responsible Party

Shen Feng

Dean of Clinical Research Institute, Director of Four Departments of Hepatology, Chief Physician, Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Eastern Hepatobiliary Surgery Hospital, Naval Medical University,

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBH-202408

Identifier Type: -

Identifier Source: org_study_id