mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

NCT04084496 | Recruiting Phase 2

• 1 other identifier: mFOLFIRINOX_PC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Although FOLFIRINOX regimen was recently presented to be effective as adjuvant chemotherapy for resectable pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating resectable pancreatic cancer patients in China. Since for many tumors, different races may show different responses to the same regimen, we design this open phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as adjuvant chemotherapy for resectable pancreatic cancer in China.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; adjuvant chemotherapy; FOLFIRINOX

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first

  up to 24 months

Secondary Outcomes (1)

• Overall survival

  up to 24 months

Study Arms (1)

FOLFIRINOX

EXPERIMENTAL

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.

Drug: Folfirinox

Interventions

Folfirinox DRUG

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.

FOLFIRINOX

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the pancreas without distant metastases.
• Receive radical resection of pancreatic cancer
• No prior cytostatic chemotherapy
• Female and male patients \> 18 and \<=79 years using contraception
• ECOG ≤ 1
• 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
• Written informed consent

You may not qualify if:

• Pregnant or lactating women
• Distant 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 ℃.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Yuhong Li

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miaozhen Qiu

CONTACT

13760612003; qiumzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

CN (1)