Clinical trial · Observational
Modified-FOLFIRINOX Regimen Based Neoadjuvant Therapy in Chinese Patients With Locally Advanced Pancreatic Cancer
NCT03469375CI-TRIAL-00032245completedClinicalTrials.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)
FOLFIRINOX regimen is first-line neoadjuvant chemotherapies for patients with locally advanced pancreatic cancer (LAPC) worldwide. However, FOLFIRINOX is not well accepted in China because of the high prevalence of adverse events and poor tolerance. To evaluate the safety and efficacy of modified-FOLFIRINOX (mFOLFIRINOX) in Chinese LAPC patients and compare survival between LAPC patients with mFOLFIRINOX-based preoperative therapy and LAPC patients who underwent surgery alone.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| modified-FOLFIRINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- LAPC patients with mFOFLRINOX-based neoadjuvant therapy
- description
- LAPC patients were enrolled prospectively and diagnosed by MDT group in our hospital. These patients further received the neoadjuvant therapy with mFOLFIRINOX, the Overall survival, Progression survival, response to mFOLFIRINOX, chemo-related Toxicities, Postoperative complications and Histopathologic staging were measured.
- interventionNames
- Drug: modified-FOLFIRINOX
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- 2014-04-01 to 2017-11-01
- description
- the duration from the date of hospital admission to death of any cause.
- measure
- Progression free survival
- timeFrame
- 2014-04-01 to 2017-11-01
- description
- the duration from the date of hospital admission to disease progression or death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patients are diagnosed by histology to have pancreatic adenocarcinoma 2. The patients are defined as locally advanced pancreatic cancer according to NCCN guideline 3. The patients prescribed mFOLFIRINOX-based neoadjuvant therapy Exclusion Criteria: 1. ECOG performance score more than 2 2. Insufficient bone marrow, liver and renal function 3. Patients with other malignancies 4. Patients were older than 85 years or less than 18 years
References
Publications (0)
Data not yet available
No reference posted for this study.