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.

Study Overview

• Status: Recruiting
• Conditions: Hyperthermic Intraperitoneal Chemotherapy; Peritoneal Metastatic Pancreatic Cancer
• Intervention / Treatment: Combination product: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wenquan Wang, Dr; Phone Number: 86 13701874954; Email: wang.wenquan@zs-hospital.sh.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Not yet recruiting
      • The Second Xiangya Hospital of Central South University
      • Contact: Wei Liu, Dr; Phone Number: 86 18321789939
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Wenquan Wang, Dr; Phone Number: 8613701874954; Email: Wang.wenquan@zs-hospital.sh.cn
      • Principal Investigator: Liang Liu, Dr
      • Sub-Investigator: Wenquan Wang, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): April 3, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 19, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Pancreatic Neoplasms; Fever; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: ZSPAC-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No