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.
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;
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);
Single group
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
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.
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).
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.
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
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