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NCT06675136 · ClinicalTrials.gov registry record · Phase 1
Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases
A Phase 1 study of Clinical Stage IVB Gastric Cancer AJCC v8 and Metastatic Gastric Adenocarcinoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06675136: Recruiting Phase 1 study of Clinical Stage IVB Gastric Cancer AJCC v8 and Metastatic Gastric Adenocarcinoma, sponsored by City of Hope Medical Center.
NCT06675136 is a Phase 1 study of Clinical Stage IVB Gastric Cancer AJCC v8 and Metastatic Gastric Adenocarcinoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 30 participants, below the 183-participant average among 7 other Clinical Stage IVB Gastric Cancer AJCC v8 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06675136, a Phase 1 study of Clinical Stage IVB Gastric Cancer AJCC v8 and Metastatic Gastric Adenocarcinoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.
Primary Outcome
Will be evaluated and graded based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Toxicities will be summarized by type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment, and reversibility or outcome. Rates and associated 95% Clopper and Pearson binomial confidence limits will be estimated.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Magnetic Resonance Imaging
- OTHER Medical Device Usage and Evaluation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-29 |
| Est. Completion | 2029-01-14 |
| Phase | Phase 1 |
What NCT06675136 shows while recruiting
NCT06675136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 183-participant average among 7 other Clinical Stage IVB Gastric Cancer AJCC v8 trials with a reported enrollment target (84% lower).
The record links to 3 conditions, with Clinical Stage IVB Gastric Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06675136 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06675136 about?
NCT06675136 is a clinical study titled "Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases". This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where ...
What is the current status of trial NCT06675136?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-10-29. Estimated completion is 2029-01-14.
What conditions does trial NCT06675136 study?
This clinical trial studies the following conditions: Clinical Stage IVB Gastric Cancer AJCC v8, Metastatic Gastric Adenocarcinoma, Metastatic Malignant Neoplasm in the Peritoneum.
What interventions are being tested in trial NCT06675136?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Medical Device Usage and Evaluation (OTHER).
Who is sponsoring clinical trial NCT06675136?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06675136 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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