The Safety And Effectiveness Of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy For Peritoneal Metastatic Pancreatic Cancer, A Phase II Clinical Trial

Study Overview

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

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.

N/A

Hyperthermic Intraperitoneal Chemotherapy
Peritoneal Metastatic Pancreatic Cancer

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

ZSPAC-09

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-19
First Submitted that Met QC Criteria 2025-04-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-27
First Posted (ACTUAL) 2025-04-27	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: HIPEC + AG Chemotherapy Group	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: HIPEC + AG Chemotherapy Group

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

Primary Outcome Measures	Measure Description	Time Frame
1-year Overall Survival (OS) Rate	The proportion of patients alive at 12 months after initiation of the combined HIPEC and systemic AG chemotherapy treatment, analyzed by Kaplan-Meier method.	From enrollment to 12 months post-treatment initiation

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival (PFS)	Time from treatment initiation to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first, assessed by blinded independent central review (BICR).	From enrollment until first documented progression or death (up to 24 months)
Objective Response Rate (ORR)	Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria during the study intervention period.	From enrollment until end of treatment (up to 12 months)
Safety and Tolerability (CTCAE v5.0)	Frequency and severity of adverse events (AEs), serious AEs (SAEs), and treatment discontinuations due to AEs, graded by CTCAE v5.0	From first HIPEC cycle to 30 days after last treatment (up to 13 months)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wenquan Wang, Dr

Phone Number: 86 13701874954

Email: wang.wenquan@zs-hospital.sh.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Obtain signed informed consent from the patient or their legal representative, with adherence to the study protocol and follow-up procedures;
Aged >=18 and <=80 years, regardless of gender;
No contraindications to surgery, with an ECOG performance status of 0-1;
Confirmed peritoneal metastasis by imaging or intraoperative detection, with rapid intraoperative histopathology indicating metastatic adenocarcinoma;
No prior anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-intensity focused ultrasound (HIFU), radiotherapy, immunotherapy, molecular targeted therapy, or traditional Chinese medicine anti-tumor treatments;
No severe hematological, cardiac, pulmonary dysfunction, or autoimmune deficiency (based on respective diagnostic criteria);
Hematological criteria: White blood cells (WBC) >=3.0 × 10⁹/L; Absolute neutrophil count (ANC) >=1.5 × 10⁹/L; Platelets (PLT) >=100 × 10⁹/L; Hemoglobin (Hgb) >=90 g/L.
Blood biochemistry criteria: AST (SGOT) and ALT (SGPT) <=2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) <=2 × ULN; Serum creatinine (CRE) <=1.5 × ULN.
Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) <=1.5 × ULN;
Compliance with study visit schedules and other protocol requirements.

Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive evidence, except for ovarian metastases;
History of other systemic malignancies within the past five years;
Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment;
Accompanied by massive ascites (extending from pelvic to upper abdominal cavity);
History of upper gastrointestinal bleeding requiring repeated blood transfusions within the past three months;
Pregnancy, autoimmune diseases, severe hyperthyroidism/hypothyroidism, central nervous system disorders, psychiatric illnesses, unstable angina, congestive heart failure, severe arrhythmias, or other uncontrolled serious medical conditions;
History of hypersensitivity to the study drugs or medications with similar chemical structures;
Patients requiring long-term warfarin anticoagulation therapy;
Poor compliance, inability or unwillingness to provide signed informed consent;
Patients likely to be lost to follow-up for ≥14 days during the treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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