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New treatment option for Adenocarcinoma Pancreas
Official title Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic Adenocarcinoma
ClinicalTrials.gov ID: NCT07253662
What this study is testing
What is Nab-paclitaxel?
Nab-paclitaxel is an investigational medicine, being studied as a potential treatment for adenocarcinoma pancreas.
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
- Palliative systemic therapy is the standard treatment option for patients with pancreatic ductal adenocarcinoma (PDAC) and peritoneal metastasis (PM), who have a median overall survival of only 6-11 months and a serious adverse event (SAE) rate of \>5%. Patients with peritoneal-only metastasis may demonstrate unique tumor biology with less potential for hematogenous and lymphatic spread, making them potential candidates for a regional approach directed at the peritoneum.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand and sign informed consent form
- Age ≥18 years
- Patient must have histologically confirmed pancreatic adenocarcinoma with either histologic confirmation or strong suspicion of peritoneal metastasis...
- ECOG performance status ≤ 2
- Pre-treatment Laboratory Parameters:
You likely can't join if
- Confirmed or suspected extra-peritoneal metastasis
- Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition.
- Life expectancy of less than 4 months.
- Prior intra-abdominal aerosol chemotherapy
- Previous anaphylactic reaction to the nab-paclitaxel drug used.
- Intra-abdominal Ascites \>5L
See the full eligibility criteria
- Ability to understand and sign informed consent form
- Age ≥18 years
- Patient must have histologically confirmed pancreatic adenocarcinoma with either histologic confirmation or strong suspicion of peritoneal metastasis on cross sectional imaging
- ECOG performance status ≤ 2
- Pre-treatment Laboratory Parameters:
- Absolute neutrophil count (ANC) \> 1500/mm3
- Platelets \> 100,000/mm3
- Hemoglobin \> 9 g/dl
- Serum total bilirubin \< 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN, unless patient is known to have chronic liver disease (hepatitis) in which case AST and ALT must be ≤ 5 x ULN.
- Creatinine clearance (Ccr) \> 40 ml/min
- No contraindications for a laparoscopy.
- The peritoneal disease does not have to be measurable by RECIST 1.1 but needs to visible on cross sectional imaging or diagnostic laparoscopy.
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Women of childbearing potential (WOCBP) and male patients with WOCBP partner must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the PIPAC or last dose...
- PIPAC access is feasible
- There is room for aerosol therapy
- There is no evidence of impending bowel obstruction
- \< 5 L of ascites
- Not a candidate for cytoreduction and HIPEC
- Confirmed or suspected extra-peritoneal metastasis
- Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy or exclusive total parenteral nutrition.
- Life expectancy of less than 4 months.
- Prior intra-abdominal aerosol chemotherapy
- Previous anaphylactic reaction to the nab-paclitaxel drug used.
- Intra-abdominal Ascites \>5L
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias...
- Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
- New York Heart Association (NYHA) Class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the...
- Exclusive total parenteral nutrition.
- Pregnancy. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- New Hyde Park, New York, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Hyde Park, New York, United States. 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.