Radiotherapy Plus Chemotherapy to Patients With CA19-9-elevated Advanced Pancreatic Cancer Who Are Not Refractory to Chemotherapy

Trial ID: NCT06250972

Interventional - Phase 3 - Recruiting

The purpose of this study is to evaluate the efficacy of chemotherapy plus radiotherapy to patients with CA19-9-elevated Advanced Pancreatic Cancer who are not refractory to chemotherapy.

Conditions

• Pancreatic Adenocarcinoma

Interventions

• Gemcitabine, Nab-paclitaxel, Irinotecan
• Intensity-Modulated Radiation Therapy (IMRT)

Eligibility

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 are not refractory to previous chemotherapy and who have not received radiotherapy.
• Locally advanced pancreatic cancer.
• Baseline serum CA19-9 \> 37 U/mL, and CA19-9 level within normal range (≤37 U/mL) after chemotherapy .
• 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.
• Primary pancreatic cancer.
• Baseline serum CA19-9 ≤ 37 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.

Sponsor

Fudan University

Source: ClinicalTrials.gov

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