Cisplatin treatment for pancreatic cancer patients with specific genetic deficiencies

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

This study is testing if a chemotherapy drug called cisplatin can help people with advanced pancreatic cancer who have specific genetic issues after their first treatment didn't work.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06095141 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a cisplatin-based regimen in patients with advanced pancreatic adenocarcinoma who have homologous recombination deficiency (HRD). Given the high lethality of pancreatic cancer and the limited treatment options available, this trial aims to explore the potential of cisplatin as a second-line treatment after prior chemotherapy failure. The study will include patients with confirmed HRD, assessing their response to cisplatin and monitoring for progression-free survival. The trial is designed to provide insights into the therapeutic implications of HRD in the context of platinum-based chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with advanced pancreatic adenocarcinoma and confirmed homologous recombination deficiency.

Not a fit: Patients who have primary pancreatic cancer or those who have previously received platinum or PARP inhibitor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival outcomes for patients with advanced pancreatic cancer and HRD.

How similar studies have performed: Other studies have shown promising results for platinum-based therapies in patients with homologous recombination deficiency, indicating a 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.
* 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.

Where this trial is running

Shanghai

• Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ying Yang, MD

Conditions Pancreatic Adenocarcinoma; Homologous Recombination Deficiency