MedTrace Logo

The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial

NCT06946901 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-04-27

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of hyperthermic intraperitoneal chemotherapy combined with intravenous chemotherapy in peritoneal metastatic pancreatic cancer. The main question it aims to answer are:

(1) Does this combined approach increase 1-year survival rates? and (2) What is the safety profile of this treatment regimen?

Participants will:

undergo baseline imaging and surgical exploration to confirm peritoneal metastasis, receive two cycles of intraperitoneal cisplatin HIPEC (70mg/m²) postoperatively, followed by systemic AG chemotherapy (nab-paclitaxel plus gemcitabine), with treatment adjustments based on regular imaging assessments and multidisciplinary team (MDT) recommendations.

Conditions

  • Hyperthermic Intraperitoneal Chemotherapy
  • Peritoneal Metastatic Pancreatic Cancer

Interventions

COMBINATION_PRODUCT

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy

* HIPEC (cisplatin 70mg/m², Day 1,3 post-surgery), 1 cycle； * Systemic AG chemotherapy (nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m², initiated, Day 1,8,15, q4 week), 4 cycles

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2026-04-03
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06946901 on ClinicalTrials.gov