Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis (STOPGAP)

January 30, 2026 updated by: Maheswari Senthil, MD, University of California, Irvine

Phase II Trial of Sequential Systemic Therapy Plus Intraperitoneal Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis (STOPGAP)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center, University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma and have received a minimum of three months of first line systemic treatment without visceral metastatic progression
  • Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy
  • Age ≥ 18 -75 years
  • Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed is attributed to malignancy (rather than comorbidities)
  • Life expectancy of greater than 6 months

  • Adequate organ and marrow function as defined below:

    1. Leukocytes: ≥ 2,000/mcL
    2. Absolute Neutrophil Count: ≥ 1,500/mcL
    3. Platelets: ≥ 80,000/mcL
    4. Total Bilirubin: within normal institutional limits
    5. AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal
    6. Creatinine: < 1.5 X institutional upper limit of normal
    7. Hemoglobin: > 8.0 g/dL (may be transfused)
    8. Serum albumin: ≥ g/dL
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Systemic treatment for unresectable or metastatic disease for more than three months prior to enrollment
  • Any evidence of distant, solid organ metastases (visceral (liver, lung, brain), bone, extra-abdominal)
  • Any evidence of extensive retroperitoneal lymph node metastases not amenable to resection during gastrectomy
  • Any evidence of small or large bowel obstruction with the exception of gastric outlet obstruction due to primary malignancy

  • Uncontrolled intercurrent illness including, but not limited to, the following conditions:

    1. Ongoing or active infection
    2. Symptomatic congestive heart failure
    3. Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment
    4. Unstable angina pectoris
    5. Cardiac arrhythmia
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.
  • Inability to comply with study and follow-up procedures as judged by the Investigator
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Has an active infection requiring systemic therapy.
  • Prior surgery that would preclude safe diagnostic laparoscopy and port placement
  • Has a known history of active tuberculosis (TB; Bacillus tuberculosis).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal Carcinomatosis
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: Leucovorin
IV Leucovorin
Drug: Paclitaxel
Intraperitoneal Paclitaxel
Drug: Paclitaxel
IV Paclitaxel
Drug: Fluorouracil
IV 5-FU
Other Names:
  • 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with Progression Free Survival at 1-Year
Time Frame: 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.
1 year
Incidence of Treatment-Emergent Adverse Events [Safety]
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival of Participants
Time Frame: From initiation of systemic treatment to up to 12 months after last patient is enrolled or until death from any cause.
To assess the overall survival of participants from the start of systemic treatment to the death from any cause.
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
Time Frame: From initiation of study treatment until patient is off study, assessed up to 12 months after the last patient has started treatment.
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.
From initiation of study treatment until patient is off study, assessed up to 12 months after the last patient has started treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of Plasma and Ascites Exosomal Gene Signature (EXOSIG)
Time Frame: From date of registration to up to 12 months after last patient is enrolled.
To assess the expression of plasma and ascites exosomal gene signature (EXO SIG) in patients with gastric cancer peritoneal carcinomatosis compared to healthy controls.
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
Time Frame: From date of registration to up to 12 months after last patient is enrolled.
To assess the correlation of changes in exosomal gene signature to treatment response in patients with gastric cancer peritoneal carcinomatosis.
From date of registration to up to 12 months after last patient is enrolled.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Maheswari Senthil, MD, Chao Family Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 17, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20206178
  • UCI 20-87 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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