Menu
Recruiting NCT06946901

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

Phase II Interventional Hyperthermic Intraperitoneal Chemotherapy Peritoneal Metastatic Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy.
Who it may be relevant to
Registry conditions: Hyperthermic Intraperitoneal Chemotherapy, Peritoneal Metastatic Pancreatic Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • 1-year Overall Survival (OS) Rate [Time frame: From enrollment to 12 months post-treatment initiation]
Secondary outcome measures (3)
  • Progression-free survival (PFS) [Time frame: From enrollment until first documented progression or death (up to 24 months)]
  • Objective Response Rate (ORR) [Time frame: From enrollment until end of treatment (up to 12 months)]
  • Safety and Tolerability (CTCAE v5.0) [Time frame: From first HIPEC cycle to 30 days after last treatment (up to 13 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • The Second Xiangya Hospital of Central South University — Changsha
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06946901 · ZSPAC-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗