RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
Cisplatin to Patients With Pancreatic Cancer and Homologous Recombination Deficiency
Cisplatin Based Regimen to Patients With Advanced Pancreatic Cancer and Homologous Recombination Deficiency
About This Trial
The purpose of this study is to evaluate the efficacy of cisplatin based regimen to patients with advanced pancreatic cancer and homologous recombination deficiency.
Who May Be Eligible (Plain English)
Who May Qualify:
- Ability to understand and the willingness to sign a written willing to sign a consent form document.
- Age ≥ 18 years and ≤ 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- diagnosed by tissue sample (biopsy-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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Cisplatin
Cisplatin 25 mg/m2, ivgtt, 30 min, D1, 8. The administration of other chemotherapeutic agents including gemcitabine, nab-paclitaxel, fluorouracil, irinotecan, capecitabine is applied according to the National Comprehensive Cancer Network (NCCN) guideline. PARP inhibitor will be recommended to patients with platinum-sensitive metastatic PDAC after six months of cisplatin based regimen.
Locations (1)
Shanghai Cancer Center
Shanghai, China