DDP ip Combined With AG in PDAC With Peritoneal Metastasis

NCT05222204 | Completed Phase 2

• 1 other identifier: CSPAC-38
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• overall survival

  patients the time from enrollment to death from any cause

  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

Study Arms (1)

IP

EXPERIMENTAL

intravenous AG+ IP cisplatin

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

Interventions

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

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

IP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cohort A
• Patients should meet the following criteria before treatment to be included in the trial:
• Voluntarily participate and sign the informed consent;
• Age ≥18 years old and ≤75 years old, gender is not limited;
• ECOG score ≤2 points;
• Pathological diagnosis of pancreatic adenocarcinoma;
• Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis;
• 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;
• No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
• Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
• Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
• Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
• 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:
• Voluntarily participate and sign the informed consent;

You may not qualify if:

• Patients were excluded from the study if they met any of the following criteria:
• Associated with other systemic malignant tumors;
• Single kidney, deformed kidney or poor renal compensation;
• Have used any other study drug within 7 days before chemotherapy;
• Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
• There is a history of allergy to the study drug or drugs of similar structure;
• Patients who are using and require long-term use of warfarin anticoagulation.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

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

Shanghai, Shanghai Municipality, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Infusions, Parenteral; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: two cohort: cohort A (first-line) and cohort B (post-line with malignant ascites )

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: February 3, 2022
• Study Start: May 15, 2022
• Primary Completion: July 8, 2024
• Study Completion: December 12, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (2)