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

Обзор

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.

Вмешательства

• Комбинированный продукт 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

Первичные конечные точки

• 1-year Overall Survival (OS) Rate [Срок оценки: From enrollment to 12 months post-treatment initiation]

Вторичные конечные точки (3)

• Progression-free survival (PFS) [Срок оценки: From enrollment until first documented progression or death (up to 24 months)]
• Objective Response Rate (ORR) [Срок оценки: From enrollment until end of treatment (up to 12 months)]
• Safety and Tolerability (CTCAE v5.0) [Срок оценки: From first HIPEC cycle to 30 days after last treatment (up to 13 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The Second Xiangya Hospital of Central South University — Чанша
• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06946901 · ZSPAC-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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