A Phase 2 interventional study of Paclitaxel and Paclitaxel in Gastric Cancer, Peritoneal Carcinomatosis and Gastroesophageal Junction Adenocarcinoma, sponsored by University of California, Irvine. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by University of California, Irvine · Phase 2, Interventional, and Treatment
This is a phase II clinical trial assessing the safety and efficacy of sequential systemic and intraperitoneal (IP) chemotherapy in patients with primary gastric/gastroesophageal junction cancer with cytology positive peritoneal lavage and/or peritoneal carcinomatosis.
Patients with histologically proven primary gastric or gastroesophageal junction (Siewert 3) adenocarcinoma with positive peritoneal cytology or peritoneal carcinomatosis detected by laparoscopy, laparotomy or imaging and without evidence of distant organ metastasis will be eligible for this study. Patients will undergo systemic therapy for 3-4 months at the discretion of the medical oncologist based on molecular makers (PD-L1, HER -2 neu, MSI). Patients without distant organ metastatic progression after completion of systemic chemotherapy, will undergo diagnostic laparoscopy and IP port placement. IP regimen will consist of IV Paclitaxel, 5- FU and Leucovorin and IP Paclitaxel. Paclitaxel 40 mg/m2 will be instilled into the peritoneal cavity through the IP port on days 1 and 8, repeated every 21 days for 3 months (3-4 cycles). Restaging imaging with CT and /or diffusion weighted MRI with contrast will be obtained 4-6 weeks after completion of IP chemotherapy. Based on response and extent of disease, patients will be triaged to one of the following treatment plans: stable disease or response and PCI >10 - continue IP chemotherapy regimen, progression - switch to second line regimen, response with PCI ≤ 10 and complete cytoreduction is feasible - consider cytoreduction surgery (CRS) with intraperitoneal chemotherapy (IPEC).
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
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Adequate organ and marrow function as defined below:
Exclusion Criteria:
Uncontrolled intercurrent illness including, but not limited to, the following conditions:
Patients will receive sequential intraperitoneal paclitaxel along with intravenous paclitaxel, 5-FU, and leucovorin on Days 1 and 8 of every 21 day cycle for 3 months.
Drug: Paclitaxel · Drug: Leucovorin · Drug: Fluorouracil
Intraperitoneal Paclitaxel
IV Paclitaxel
IV Leucovorin
IV 5-FU
Also known as: 5-FU
Participants with Progression Free Survival at 1-Year
Progression-free survival is defined as the duration of time from start of systemic treatment to time of progression, death, or clinical deterioration attributed to disease progression as judged by the investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm and/or appearance of new lesions.
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events [Safety]
To evaluate the safety of IP paclitaxel and IV paclitaxel, 5-FU, and leucovorin in patients with primary gastric/GEJ adenocarinoma with peritoneal carcinomatosis determined by the incidence of treatment-emergent adverse events. Adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
Time frame: From date of study treatment initiation to first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, assessed up to 12 months after the last patient is enrolled.
Overall Survival of Participants
To assess the overall survival of participants from the start of systemic treatment to the death from any cause.
Time frame: From initiation of systemic treatment to up to 12 months after last patient is enrolled or until death from any cause.
Patient Reported Quality of Life Outcomes
To assess the quality of life of participants such as mobility, self-care, daily activities, pain/discomfort and anxiety/depression and a visual analog scale (VAS). VAS consists of endpoints labeled best imaginable health status at the top and worse imaginable health state at the bottom having numeric values of 100 and 0 respectively.
Time frame: From initiation of study treatment until patient is off study, assessed up to 12 months after the last patient has started treatment.
Expression of Plasma and Ascites Exosomal Gene Signature (EXOSIG)
To assess the expression of plasma and ascites exosomal gene signature (EXO SIG) in patients with gastric cancer peritoneal carcinomatosis compared to healthy controls.
Time frame: From date of registration to up to 12 months after last patient is enrolled.
Correlation of Plasma and Ascite Exosomal Gene Signature (EXOSIG) to Treatment Response
To assess the correlation of changes in exosomal gene signature to treatment response in patients with gastric cancer peritoneal carcinomatosis.
Time frame: From date of registration to up to 12 months after last patient is enrolled.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of California, Irvine