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

NCT06946901 | Recruiting Phase 2

• 1 other identifier: ZSPAC-09
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-free survival (PFS)

  From enrollment until first documented progression or death (up to 24 months)

• Objective Response Rate (ORR)

  From enrollment until end of treatment (up to 12 months)

• Safety and Tolerability (CTCAE v5.0)

  From first HIPEC cycle to 30 days after last treatment (up to 13 months)

Study Arms (1)

HIPEC + AG Chemotherapy Group

EXPERIMENTAL

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

Interventions

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

* 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

HIPEC + AG Chemotherapy Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (2)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Central Study Contacts

Wenquan Wang, Dr

CONTACT

86 13701874954; wang.wenquan@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: April 3, 2025
• Primary Completion: April 3, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

CN (2)