RecruitingPhase 2NCT06946901

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

Enrollment

90 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining heated chemotherapy directly into the abdominal cavity (called HIPEC — hyperthermic intraperitoneal chemotherapy) with standard intravenous chemotherapy can be safe and effective for pancreatic cancer that has spread inside the abdomen (peritoneal metastasis). **You may be eligible if...** - You are between 18 and 80 years old - You have pancreatic cancer that has spread to the lining of the abdomen (peritoneal metastasis), confirmed by imaging or during surgery - You have not received any prior cancer treatments (surgery, chemotherapy, radiation, etc.) - You are in good enough health to undergo surgery (ECOG 0–1) **You may NOT be eligible if...** - You have already received anti-cancer treatment - Your overall health makes surgery too risky - Your cancer has spread to organs beyond the abdomen - You have significant other illnesses that would interfere with the treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTHyperthermic 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

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NCT06946901


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