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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Not yet recruiting

Study contacts

• Study coordinator: Wenquan Wang, Dr
• Email: wang.wenquan@zs-hospital.sh.cn
• Phone: 86 13701874954

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biopsy and Resection Growth Patterns in Colorectal Peritoneal Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.