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New treatment option for Synchronous Gastric Peritoneal Carcinomatosis
Official title Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
ClinicalTrials.gov ID: NCT07475286
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for synchronous gastric peritoneal carcinomatosis.
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
- This trial will administer laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with peritoneal carcinomatosis from gastric cancer (GPC) who are receiving standard of care systemic chemotherapy.
- 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 and older
You may be able to join if
- Histologically proven, synchronous gastric and/or gastroesophageal junction (Siewert 3) adenocarcinoma with either positive peritoneal cytology...
- Patients must be 18 years of age or older at time of informed consent.
- ECOG performance status of ≤ 2\ \ Note: ECOG PS of 2 is allowed only if debilitation is caused by the gastric cancer and not by other comorbidities.
- Must have normal organ and marrow function following completion of 4-6 months systemic therapy and prior to enrollment as assessed on basic...
- Patient should have a life expectancy of \>6 months per the discretion of the treating surgical oncologist and/or medical oncologist in relation to...
You likely can't join if
- Patients with MSI-H tumors, dMMR, TMB \> 30, CPS \> 40, POL-E mutation, Claudin 18.2 positive tumors, BRAFV600E, RET fusions, HER-2-neu (3+ on IHC)...
- Extensive retroperitoneal lymph node involvement not amenable to surgical resection during gastrectomy.
- Recurrent large or small bowel obstruction attributable to the cancer (except for gastric outlet obstruction).
- Prior abdominal surgeries that preclude safe and effective laparoscopy/laparoscopic HIPEC.
- Significant ascites requiring repeated drainage for symptomatic relief.
- Other malignancy within the preceding 3 years (except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical...
See the full eligibility criteria
- Histologically proven, synchronous gastric and/or gastroesophageal junction (Siewert 3) adenocarcinoma with either positive peritoneal cytology (micPC) or macroscopic carcinomatosis (macPC) (stage IV), diagnosed by...
- Patients must be 18 years of age or older at time of informed consent.
- ECOG performance status of ≤ 2\ \ Note: ECOG PS of 2 is allowed only if debilitation is caused by the gastric cancer and not by other comorbidities.
- Must have normal organ and marrow function following completion of 4-6 months systemic therapy and prior to enrollment as assessed on basic laboratory tests: Hemoglobin ≥ 8.0 g/dL Leukocytes ≥ 3,000/mcL Absolute...
- Patient should have a life expectancy of \>6 months per the discretion of the treating surgical oncologist and/or medical oncologist in relation to comorbidities and volume of disease.
- Patients must have received at least 4 months (maximum 6 months) of 1st or 2nd line systemic therapy at the discretion of the treating medical oncologist and/or surgical oncologist and exhibit no evidence of...
- Patients with stable oligometastatic liver only metastasis (≤ 3 lesions, each \< 3 cm in maximum dimension), ovarian-only metastases, or lung-only metastases (≤ 5 lesions, each \< 1 cm) that are amenable to curative...
- Sexually active fertile people and their partners must agree to use highly effective method of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier...
- Female people of childbearing potential must not be pregnant or breastfeeding at screening. Female people are considered to be of childbearing potential unless one of the following criteria is met:
- Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \> 45 years-of-age in the absence of other...
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Must be able to read and write in English.
- Patients with MSI-H tumors, dMMR, TMB \> 30, CPS \> 40, POL-E mutation, Claudin 18.2 positive tumors, BRAFV600E, RET fusions, HER-2-neu (3+ on IHC) or positive on FISH will be excluded.
- Extensive retroperitoneal lymph node involvement not amenable to surgical resection during gastrectomy.
- Recurrent large or small bowel obstruction attributable to the cancer (except for gastric outlet obstruction).
- Prior abdominal surgeries that preclude safe and effective laparoscopy/laparoscopic HIPEC.
- Significant ascites requiring repeated drainage for symptomatic relief.
- Other malignancy within the preceding 3 years (except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical cancer in-situ).
- Patients should have recovered to baseline from any clinically significant adverse events from prior treatment.
- Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV...
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, 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 Pittsburgh, Pennsylvania, 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.