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RECRUITING
NCT06946901
PHASE2

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-04-03

Completion Date

2027-12-31

Last Updated

2025-04-27

Healthy Volunteers

No

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

Locations (2)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China