Actively Recruiting

Phase 2
Age: 18Years - 79Years
All Genders
NCT04084496

mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Led by Sun Yat-sen University · Updated on 2025-05-30

80

Participants Needed

1

Research Sites

330 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma of the pancreas without distant metastases.
  • Underwent radical surgery to remove pancreatic cancer.
  • No prior chemotherapy treatment.
  • Male or female patients aged over 18 and up to 79 years using contraception.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Adequate bone marrow function with ANC ≥ 2.0 x 10^9/L, platelets ≥ 90 x 10^9/L, hemoglobin ≥ 90 g/L.
  • Adequate liver function with AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastasis present, serum bilirubin ≤ 1.2 x ULN.
  • Adequate renal function with creatinine ≤ 1.25 times ULN.
  • Good compliance with study procedures.
  • Able to provide written informed consent.
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women.
  • Presence of distant metastases.
  • Severe gastrointestinal bleeding requiring frequent blood transfusions.
  • Refusal to use appropriate contraception (including males).
  • Allergy to Oxaliplatin, Irinotecan, Leucovorin, or 5-Fluorouracil.
  • Uncontrolled severe systemic diseases such as respiratory, cardiac, liver, or renal conditions.
  • Having another cancer or history of malignancy within 5 years, except non-melanoma skin cancer or cervical carcinoma in situ.
  • Psychiatric illness preventing informed consent.
  • Concurrent use of other anticancer agents.
  • Use of investigational anticancer drugs within 4 weeks before study entry.
  • Known HIV infection.
  • History of chronic diarrhea, nausea, or vomiting.
  • Sensory peripheral neuropathy grade 2 or higher.
  • Recent major heart conditions including myocardial infarction within 6 months, congestive heart failure, or unstable angina.
  • Active infection or fever of 38°C or higher.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

M

Miaozhen Qiu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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