The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With In
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) Wha
| Condition(s) | Hyperthermic Intraperitoneal Chemotherapy, Peritoneal Metastatic Pancreatic Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 o |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Shanghai Zhongshan Hospital |
| Locations | Changsha, Hunan, China; Shanghai, Shanghai Municipality, China |
| Start date | 2025-04-03 |
| NCT ID | NCT06946901 |
| Official listing | https://clinicaltrials.gov/study/NCT06946901 |