Clinical trial · Interventional
Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer
A Prospective, Randomized, Controlled Trial of Chemotherapy for Advanced Pancreatic Cancer Based on Organoid Drug Sensitivity Test
NCT04931381CI-TRIAL-00060013unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore whether chemotherapy regimens guided by organoid drug sensitivity test can improve the outcomes of advanced pancreatic cancer. At the same time, this study will evaluate the successful stablishment rate of organoid from biopsy tissue , and explore the concordance between drug sensitivity test results and patients' treatment response.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy guided by organoid drug sensitivity test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Organoid-Guided Chemotherapy
- description
- The pancreatic cancer specimens are obtained from biopsy to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan). Patients will receive relatively sensitive chemotherapy regimen based on the test results. Chemotherapy should start within 1 months after biopsy, and be given at least 1 cycle.
- interventionNames
- Other: Chemotherapy guided by organoid drug sensitivity test
- type
- NO_INTERVENTION
- label
- Physician-decided Chemotherapy
- description
- The pancreatic cancer specimens are obtained from biopsy to be cultured for organoids. Then drug sensitivity is tested using organoid to obtain the sensitivity to the first-line drugs for pancreatic cancer (Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan). Physician will decide the the adjuvant chemotherapy regimen, according to National Comprehensive Cancer Network (NCCN) guideline for pancreatic ductal adenocarcinoma. And they don't know the drug sensitivity test results. Chemotherapy should start within 1 months after biopsy, and be given at least 1 cycle.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.