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A prospective, randomized controlled study of mFOLFIRINOX versus gemcitabine combined with albumin paclitaxel in the treatment of patients with unresectable pancreatic cancer

A prospective, randomized controlled study of mFOLFIRINOX versus gemcitabine combined with albumin paclitaxel in the treatment of patients with unresectable pancreatic cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034870
Enrollment
Unknown
Registered
2020-07-22
Start date
2020-07-27
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Group A:Oxaliplatin: 85 mg/m2, intravenous infusion, day 1
leucovorin: 400 mg/m2, intravenous infusion, day 1
irinotecan: 150 mg/m2 , Intravenous infusion, day 1
bolus injection of 5-FU: 2400 mg/m2, intravenous infusion, 46 hours
once every two weeks
Group B:Albumin paclitaxel (nab-paclitaxel): 125mg/m2, intravenous infusion (30 minutes), on day 1, 8
gemcitabine (GEM): 1000 mg/m2, intravenous infusion, on day 1, 8
Once every three weeks

Sponsors

Wannan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 years old and = 100g/L; absolute neutrophil count (ANC) >= 1.5 * 10^9/L; platelets >= 100 * 10^9/L; ALT, AST = 35g/L. 7) Patients voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) People with a history of other malignant diseases in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. 2) Any way of anti-tumor treatment before pancreatic tumor resection, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy, etc.; 3) Have used any other study drugs within 6 weeks before enrollment; 4) Pregnant or breastfeeding women; 5) Women of childbearing age who had a positive pregnancy test at baseline or who did not have a pregnancy test. Menopausal women must have menopause for at least 12 months before they are considered impossible for pregnancy; 6) Those who are known to be severely allergic to gemcitabine, albumin paclitaxel and mFOLFIRINOX combination regimen drugs; 7) Obvious blood coagulation disorder, active bleeding and bleeding tendency; 8) Interstitial pneumonia or pulmonary fibrosis; 9) Uncontrollable pleural effusion or ascites; 10) People with severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months); 11) Patients judged by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
OS;

Secondary

MeasureTime frame
PFS;ORR;DCR;AE;QOL;

Countries

China

Contacts

Public ContactWang Xiaoming

Wannan Medical College

wangxiaomingdoct@163.com+86 0553 5739205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026