Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency

• Status: Recruiting
• Trial end date: 2026-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of cisplatin based regimen to patients with advanced pancreatic cancer and homologous recombination deficiency.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin

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.

• Tumor progression after at least one line of chemotherapy.

• Genetic or molecular test confirmed the presence of homologous recombination deficiency.

• 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.

• Patients who have received platinum or PARPi treatment.

• 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 cisplatin or other platinum drugs.

• Patients who are unwilling or unable to comply with study procedures.