DDP ip Combined With AG in PDAC With Peritoneal Metastasis

NCT ID: NCT05222204

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2024-12-12

Brief Summary

intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis

Conditions

Pancreatic Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IP

intravenous AG+ IP cisplatin

Group Type: EXPERIMENTAL

intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel

Intervention Type: DRUG

intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis

Interventions

intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel

intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CSPAC-38

Identifier Type: -

Identifier Source: org_study_id