Using organoids to guide chemotherapy for pancreatic cancer

A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test

This study is testing whether using lab-grown mini tumors from pancreatic cancer patients can help doctors choose the best chemotherapy to improve treatment results after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT04931394 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if adjuvant chemotherapy regimens, guided by drug sensitivity tests using organoids derived from pancreatic cancer patients, can enhance treatment outcomes. The study will assess the establishment rate of organoids from fresh surgical specimens and evaluate the correlation between drug sensitivity test results and patient treatment responses. It is a single-center, prospective, open-label, randomized, controlled trial focusing on patients who have undergone complete surgical resection of pancreatic cancer. The trial will also investigate the radiosensitivity of organoids in relation to patient responses to radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have undergone complete R0 resection for pancreatic adenocarcinoma without evidence of metastases.

Not a fit: Patients with prior chemotherapy or radiotherapy, or those with metastatic disease, are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective chemotherapy regimens tailored to individual patients' tumor characteristics, improving survival rates for pancreatic cancer.

How similar studies have performed: Previous studies have shown promising results using organoids for drug sensitivity testing in pancreatic cancer, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

* Age≥18 years old and ≤80 years old.
* Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases.
* Histology confirmed pancreatic adenocarcinoma.
* Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
* No metastases are found in preoperative examination.
* No prior chemotherapy or radiotherapy.
* 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, 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.

Conditions Pancreatic Cancer; Organoid; Drug Sensitivity Test; Chemotherapy