Chemotherapy guided by organoid testing for advanced pancreatic cancer
A Prospective, Randomized, Controlled Trial of Chemotherapy for Advanced Pancreatic Cancer Based on Organoid Drug Sensitivity Test
This study is testing if using personalized chemotherapy based on lab tests from patients' tumor samples can improve treatment results for people with advanced pancreatic cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04931381 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if chemotherapy regimens tailored based on organoid drug sensitivity tests can enhance treatment outcomes for patients with advanced pancreatic cancer. It will assess the establishment rate of organoids from biopsy samples and evaluate the correlation between drug sensitivity test results and patient treatment responses. The trial is a single-center, prospective, open-label, randomized, controlled design, focusing on the effectiveness of personalized chemotherapy approaches. Additionally, the study will investigate the radiosensitivity of organoids in relation to patient responses to radiotherapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with confirmed advanced pancreatic adenocarcinoma who can undergo a core needle biopsy.
Not a fit: Patients with severe comorbidities or those whose tumors cannot be biopsied may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective chemotherapy treatments for patients with advanced pancreatic cancer.
How similar studies have performed: Previous studies have shown promising results with organoid models in assessing drug sensitivity, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥18 years old and ≤80 years old. * Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma. * Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma. * Patient must have a tumor lesion that is amenable to a core needle biopsy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of greater than 90 days, as judged by the investigator. * Routine blood test: absolute neutrophil count\>1500/mm3, platelet\>100000/mm3. * Normal liver function: serum total bilirubin≤2.0mg/dl, alanine aminotransferase (ALT) and aspertate aminotransferase (AST) \<2.5 times of the upper limit of normal value. * Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min. * The pancreatic cancer organoid were cultured successfully. * No severe comorbidities. Exclusion Criteria: * Patients with poor condition can not tolerate chemotherapy and targeted therapy. * Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure. * Patients diagnosed with other cancer within 5 years. * Patients who are pregnant or breastfeeding. * Patients enrolled in other clinical trials or incompliant of regular follow up. * Patients who did not provide an informed consent.
Where this trial is running
Shanghai
- Changhai Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Gang Jin, M.D. — Changhai Hospital, Shanghai, China
- Study coordinator: Shiwei Guo, M.D.
- Email: gestwa@163.com
- Phone: +8618621500666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.