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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital

About this 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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

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

Treatment groups

90 Participants
are divided into 1 treatment group

Sponsors and collaborators