NCT04931394CompletedPhase 3
Organoid-Guided Adjuvant Chemotherapy for Pancreatic Cancer
A Prospective, Randomized, Controlled Trial of Adjuvant Chemotherapy for Pancreatic Cancer Based on Organoid Drug Sensitivity Test
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to explore whether adjuvant chemotherapy regimens guided by organoid drug sensitivity test can improve the outcomes of pancreatic cancer. At the same time, this study will evaluate the successful establishment rate of organoid from fresh surgical specimens , and explore the concordance between drug sensitivity test results and patients' treatment response.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (actual)
- First submitted
- 15 Jun 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 31 May 2024
- Lead sponsor
- Changhai Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT04931394
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 240
- From 1 Jun 2021 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.