Clinical trial NCT06946901: The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
Official title: The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hyperthermic Intraperitoneal Chemotherapy
Peritoneal Metastatic Pancreatic Cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 1-year Overall Survival (OS) Rate
timeFrame: From enrollment to 12 months post-treatment initiation
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From enrollment until first documented progression or death (up to 24 months)
measure: Objective Response Rate (ORR)
timeFrame: From enrollment until end of treatment (up to 12 months)
measure: Safety and Tolerability (CTCAE v5.0)
timeFrame: From first HIPEC cycle to 30 days after last treatment (up to 13 months)
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: