Status:
RECRUITING
mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer
Lead Sponsor:
Fudan University
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer.
Detailed Description
Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemothera...
Eligibility Criteria
Inclusion
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years and ≤ 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
- Patients who have not received any form of anti-tumor therapy.
- Baseline serum CA19-9 ≤ 37 U/mL, CEA≤ 5.2 ng/mL, and CA125 ≤ 35 U/mL.
- Presence of at least of one measurable lesion in agreement to RECIST criteria.
- The expected survival ≥ 3 months.
- Adequate organ performance based on laboratory blood tests.
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion
- Pregnant or nursing women.
- Patients who have received any form of anti-tumor therapy.
- Baseline serum CA19-9 \> 37 U/mL, CEA \> 5.2 ng/mL, or CA125 \> 35 U/mL.
- The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
- Renal insufficiency or dialysis
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
- Patients who are allergic to oxaplatin or other chemotherapy drugs.
- Patients who are unwilling or unable to comply with study procedures.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06149689
Start Date
January 10 2024
End Date
October 31 2026
Last Update
August 7 2025
Active Locations (1)
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1
Shanghai Cancer Center
Shanghai, China