Combining mFOLFIRINOX and radiotherapy for advanced pancreatic cancer with normal CA19-9 levels

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

This study is testing if combining a specific chemotherapy and radiotherapy can help people with advanced pancreatic cancer who have normal CA19-9 levels live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06149689 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of mFOLFIRINOX chemotherapy combined with radiotherapy in patients diagnosed with advanced pancreatic adenocarcinoma who have normal levels of the CA19-9 biomarker. Given that a significant portion of pancreatic cancer patients may present with normal CA19-9 levels, this trial aims to determine if this specific group responds better to the combined treatment approach. The study will measure progression-free survival, overall survival, and other response rates to assess the treatment's efficacy. Participants must meet specific eligibility criteria, including age and health status, to ensure safety and reliability of results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed advanced pancreatic adenocarcinoma and normal CA19-9 levels.

Not a fit: Patients who have previously received anti-tumor therapy or have elevated CA19-9 levels will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with a challenging form of pancreatic cancer.

How similar studies have performed: Previous studies have suggested that patients with normal CA19-9 levels may respond better to combined chemotherapy and radiotherapy, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Shanghai

• Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Guopei Luo, MD — Fudan University
• Study coordinator: Ying Yang, MD

Conditions Pancreatic Adenocarcinoma