Combining heated chemotherapy with intravenous chemotherapy for pancreatic cancer spread in the abdomen

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

This study is testing if a new combination of heated chemotherapy and regular chemotherapy can help people with advanced pancreatic cancer live longer and stay safe during treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Changsha, Hunan and 1 other locations)
• Trial ID: NCT06946901 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with intravenous chemotherapy for patients with peritoneal metastatic pancreatic cancer. Participants will undergo surgical exploration to confirm metastasis, followed by two cycles of HIPEC using cisplatin, and then systemic chemotherapy with nab-paclitaxel and gemcitabine. The study aims to determine if this combined approach improves one-year survival rates and assesses the safety profile of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed peritoneal metastatic pancreatic cancer and no prior anti-tumor therapies.

Not a fit: Patients with severe underlying health conditions or those who have received prior anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced pancreatic cancer that has spread to the peritoneum.

How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this novel treatment strategy.

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.

Where this trial is running

Changsha, Hunan and 1 other locations

• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Wenquan Wang, Dr

Conditions: Hyperthermic Intraperitoneal Chemotherapy, Peritoneal Metastatic Pancreatic Cancer