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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
* 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
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITING1-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.
Time frame: From enrollment to 12 months post-treatment initiation
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).
Time frame: 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.
Time frame: 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
Time frame: From first HIPEC cycle to 30 days after last treatment (up to 13 months)
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