mFOLFIRINOX Plus Radiotherapy to Patients With CA19-9-normal Advanced Pancreatic Cancer

Recruiting now · Phase 2

Conditions studied: Pancreatic Adenocarcinoma

In brief

The purpose of this study is to evaluate the efficacy of mFOLFIRINOX plus radiotherapy to Patients with CA19-9-normal Advanced Pancreatic Cancer.

Key facts

Study ID

NCT06149689

Run by

Fudan University

People needed

30

Starts

2024-01-10

Expected to finish

2026-10-31

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Cancer Center — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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