Cisplatin Based Regimen to Patients With Advanced Pancreatic Cancer and Homologous Recombination Deficiency

Trial ID: NCT06095141

Interventional - Phase 2/3 - Recruiting

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

Conditions

Pancreatic Adenocarcinoma
Homologous Recombination Deficiency

Interventions

Cisplatin

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.
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.

Sponsor

Fudan University

Source: ClinicalTrials.gov

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