MFOLFIRINOX As Adjuvent Chemotherapy In Treating Chinese Pancreatic Cancer Patients

Study Overview

mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

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.

This is a phase II study. Patients with resectable pancreatic carcinoma will receive adjuvant chemotherapy of FOLFIRINOX for 6 months. Primary endpoint is the disease free survival. Secondary endpoints are overall survival, safety and quality of life.

Pancreatic Cancer

DRUG: Folfirinox

mFOLFIRINOX_PC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-09-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-24
First Submitted that Met QC Criteria 2019-09-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-30
First Posted (ACTUAL) 2019-09-10	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: FOLFIRINOX 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 continu	DRUG: Folfirinox 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 continu

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: FOLFIRINOX

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 continu

DRUG: Folfirinox

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 continu

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Overall survival	From the date of first drug administration until the date of death	up to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Miaozhen Qiu

Phone Number: 13760612003

Email: qiumzh@sysucc.org.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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 ℃.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Yuhong Li, Sun Yat-sen University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record