Clinical trial · Interventional
DDP ip Combined With AG in PDAC With Peritoneal Metastasis
Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis
NCT05222204CI-TRIAL-00090081completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IP
- description
- intravenous AG+ IP cisplatin
- interventionNames
- Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- patients the time from enrollment to death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: cohort A Patients should meet the following criteria before treatment to be included in the trial: 1. Voluntarily participate and sign the informed consent; 2. Age ≥18 years old and ≤75 years old, gender is not limited; 3. ECOG score ≤2 points; 4. Pathological diagnosis of pancreatic adenocarcinoma; 5. Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis; 6. The time from the end of adjuvant chemotherapy after surgery is more than 6 months, or they have not received any form of anti-tumor therapy before, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy; 7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards); 8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL; 9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN; 10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN; 11. Able to comply with research visit plans and other protocol requirements. inclusion criteria (Cohort B) Patients should meet the following criteria before treatment to be included in the trial: 1. Voluntarily participate and sign the informed consent; 2. Age ≥18 years old and ≤75 years old, gender is not limited; 3. ECOG score ≤2 points; 4. Pathological diagnosis of pancreatic adenocarcinoma; 5. malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed. 6. At least one systemic chemotherapy has been used; 7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards); 8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL; 9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN; 10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN; 11. Able to comply with research visit plans and other protocol requirements. Exclusion Criteria: Patients were excluded from the study if they met any of the following criteria: 1. Associated with other systemic malignant tumors; 2. Single kidney, deformed kidney or poor renal compensation; 3. Have used any other study drug within 7 days before chemotherapy; 4. Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled; 5. There is a history of allergy to the study drug or drugs of similar structure; 6. Patients who are using and require long-term use of warfarin anticoagulation.
References
Publications (0)
Data not yet available
No reference posted for this study.