Using mFOLFIRINOX chemotherapy for treating pancreatic cancer in Chinese patients
A Phase II Study With mFOLFIRINOX as Adjuvent Chemotherapy for Resectable Pancreas Carcinoma
This study is testing if a specific chemotherapy called mFOLFIRINOX can help Chinese patients with resectable pancreatic cancer live longer and feel better after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04084496 on ClinicalTrials.gov |
What this trial studies
This phase II study aims to evaluate the efficacy and safety of mFOLFIRINOX as adjuvant chemotherapy for patients with resectable pancreatic cancer in China. Participants will receive the FOLFIRINOX regimen for a duration of six months following radical resection of their cancer. The primary endpoint of the study is disease-free survival, while secondary endpoints include overall survival, safety, and quality of life assessments. The study is designed to address the lack of evidence regarding this treatment approach in the Chinese population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 79 with histologically confirmed resectable pancreatic adenocarcinoma and good physical condition.
Not a fit: Patients with distant metastasis or severe systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective adjuvant chemotherapy option for Chinese patients with resectable pancreatic cancer.
How similar studies have performed: Other studies have shown the effectiveness of FOLFIRINOX in various populations, but this specific application in Chinese patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 ℃.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yuhong Li — Sun Yat-Sen University Cancer Center
- Study coordinator: Miaozhen Qiu
- Email: qiumzh@sysucc.org.cn
- Phone: 13760612003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.