Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.

Last updated: February 13, 2023
Sponsor: Yuhong Li
Overall Status: Completed

Phase

2

Condition

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT04224402
FOLFIRINOX-PC-Adjuvant
  • Ages 18-79
  • All Genders

Study Summary

This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients should be voluntary to the trial and provide with signed informed consent.
  2. Histologically confirmed diagnosis of pancreatic cancer
  3. Male or female, Age: 18-79 years old.
  4. No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scanafter radical surgery.
  5. the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery.
  6. No previous chemotherapy
  7. Eastern Cooperative Oncology Group(ECOG) performance status of 0-1
  8. normal function of organ system including the followings.
  • No hematologic dysfunction(Platelets ≥90×10^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L).
  • Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN.
  • Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula).
  1. ECOG scored as 0-1.
  2. Life expectancy > 3 months.

Exclusion

Exclusion Criteria:

  1. Patient is concurrently using other antineoplastic agent.
  2. Known severe hypersensitivity to drugs in the regimen.
  3. Patient has a concurrent malignancy or has a malignancy within 5 years of studyenrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma insitu).
  4. Evidence of serious heart disease, including recorded history of congestiveheart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs,clinical diagnosed cardiac valve disease, history of serious myocardial infarction andintractable hypertension.
  5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
  6. Evidence of active infection or active epidemic disease.
  7. Psychiatric illness that would prevent the patient from giving informed consent
  8. Pregnant or lactating women.

Study Design

Total Participants: 80
Study Start date:
January 31, 2020
Estimated Completion Date:
December 31, 2022

Study Description

The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

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