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

NCT ID: NCT06946901

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2027-12-31

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.

Conditions

Hyperthermic Intraperitoneal Chemotherapy; Peritoneal Metastatic Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIPEC + AG Chemotherapy Group

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: NOT_YET_RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenquan Wang, Dr

Role: CONTACT

wang.wenquan@zs-hospital.sh.cn

86 13701874954

Facility Contacts

Wei Liu, Dr

Role: primary

86 18321789939

Wenquan Wang, Dr

Role: primary

Wang.wenquan@zs-hospital.sh.cn

8613701874954

Other Identifiers

ZSPAC-09

Identifier Type: -

Identifier Source: org_study_id