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Tests treatment safety and results for Hyperthermic Intraperitoneal Chemotherapy
Official title The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
ClinicalTrials.gov ID: NCT06946901
What this study is testing
What is Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy?
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hyperthermic intraperitoneal chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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, treatment chemotherapy, high-intensity focused ultrasound (HIFU)...
You likely can't join if
- 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...
See the full eligibility 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, treatment chemotherapy, high-intensity focused ultrasound (HIFU), radiotherapy, immunotherapy, molecular targeted therapy, or traditional...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.