Status:
UNKNOWN
The Combination Chemotherapy of SIRIOX as First- or Second-Line Chemotherapy for Pancreatic Cancer
Lead Sponsor:
Fudan University
Conditions:
Carcinoma, Pancreatic Ductal
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Pancreatic cancer represents the most lethal of the common malignancies with a 5-year survival rate of less than 5%. For patients who are eligible for potentially curative resection, despite mortality...
Detailed Description
Pancreatic cancer (mainly pancreatic ductal adenocarcinoma, PDAC) is a disease with extremely poor prognosis, and is often fatal. Surgical resection is the only potentially curative technique for mana...
Eligibility Criteria
Inclusion
- Patients aged 18 - 75 years old at the time of signing the ICF.
- Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant are acceptable without Irinotecan, Oxaliplatin, or S1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Adequate hematologic function defined as: absolute neutrophil count (ANC) \>= 2,000/μL; platelets count \>= 100,000/μL; hemoglobin must be \>= 10 g/dL (can be corrected by growth factor or transfusion).
- Adequate hepatic function defined as: serum bilirubin =\< 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =\< 3-fold ULN (5-fold ULN if liver metastasis is observed).
- Adequate renal function with: serum creatinine =\< 1.3 mg/dL or calculated creatinine clearance \>= 60 mL/minute according to the Cockcroft and Gault formula.
- At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Life expectancy over 12 weeks.
- Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months.
- Willing and able to comply with all aspects of the treatment protocol.
- Provide written informed consent.
Exclusion
- Patients who are unwilling or unable to comply with the study protocol;
- Existing anticancer treatment-related toxicities of Grades \>= 2 (except for alopecia and neuropathy) according to Common Terminology Criteria for Adverse Events (CTCAE v4.03).
- Simultaneously using targeted therapies, such as Erlotinib, Nimotuzumab etc;
- Any severe or uncontrolled systemic disease (e.g., unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes mellitus, massive active bleeding);
- Large operations were performed within 14 days before entering the study, or there were surgical incisions that were not completely healed;
- Women who are pregnant or breastfeeding;
- Ascertained hypersensitivity to investigational product, Oxaliplatin, Irinotecan, and S1 or any of the excipients used in the study.
- History of other malignancies within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ;
- Obvious gastrointestinal injury history, the researchers estimate may significantly affect the absorption of S1 on the whole, including the ability to swallow drugs;
- Other combinations of anticancer therapies (including LHRH agonists, anticancer herbs, immunotherapy), except steroid hormones;
- Patients with UGT1A1 mutations or congenital disease lack of UGT1A1 expression (e.g. Crigler-Najjar syndrome and Gilbert syndrome);
- Patients with DPD enzyme deficiency.
- Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03403101
Start Date
July 1 2020
End Date
July 1 2024
Last Update
April 9 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032
2
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
Shanghai, China, 200032