Clinical trial · Interventional
mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer
Phase Ⅱ Trial to Investigate the Efficacy and Safety of mFOLFIRINOX in Patients With Metastatic Pancreatic Cancer in China
NCT02028806CI-TRIAL-00064021completedPhase 2ClinicalTrials.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)
This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.
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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFIRINOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFIRINOX
- description
- Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
- interventionNames
- Drug: mFOLFIRINOX
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- Up to 24 weeks
Secondary outcomes (4)
- measure
- Progression free survival
- timeFrame
- From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have provided a signed Informed Consent Form * ECOG performance status of 0-1 * BMI ≥ 18.5 * Age: 18-65 years old * Histologically confirmed diagnosis of metastatic pancreatic cancer * No prior palliative chemotherapy * Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria * Life expectancy ≥ 3 months * Patient has adequate bone marrow and organ function * Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L * Platelets ≥ 90 x 109/L * Hemoglobin ≥ 90 g/L * Patient has adequate liver function * AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) * Serum bilirubin ≤ 1.2 x ULN * Creatinine ≤ 1.25 times ULN * Good compliance Exclusion Criteria: * Pregnant or lactating women * Brain metastasis or only with bone metastasis. * Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions. * Refuse to take appropriate contraceptive measures (including male patients). * Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil. * Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases. * Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ). * Psychiatric illness that would prevent the patient from giving informed consent. * Patient is concurrently using other antineoplastic agent * Patient has used investigational antineoplastic agent within 4 weeks prior to entry. * Known HIV-positivity. * No history of chronic diarrhea, nausea or vomit. * No ≥ grade 2 sensory peripheral neuropathy. * A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina. * Infectious disease or inflammation with body temperature ≥ 38 ℃.
References
Publications (1)
- DERIVEDWang ZQ, Zhang F, Deng T, Zhang L, Feng F, Wang FH, Wang W, Wang DS, Luo HY, Xu RH, Ba Y, Li YH. The efficacy and safety of modified FOLFIRINOX as first-line chemotherapy for Chinese patients with metastatic pancreatic cancer. Cancer Commun (Lond). 2019 May 8;39(1):26. doi: 10.1186/s40880-019-0367-7. PMID 31068222