The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- 1-year Overall Survival (OS) Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HIPEC + AG Chemotherapy Group
干预措施: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy (Combination Product)
结局指标
主要结局
1-year Overall Survival (OS) Rate
时间窗: From enrollment to 12 months post-treatment initiation
The proportion of patients alive at 12 months after initiation of the combined HIPEC and systemic AG chemotherapy treatment, analyzed by Kaplan-Meier method.
次要结局
- Progression-free survival (PFS)(From enrollment until first documented progression or death (up to 24 months))
- Objective Response Rate (ORR)(From enrollment until end of treatment (up to 12 months))
- Safety and Tolerability (CTCAE v5.0)(From first HIPEC cycle to 30 days after last treatment (up to 13 months))