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Gastric CancerPhase 2STOPGAPNCT04762953

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

A Phase 2 study testing Paclitaxel, Leucovorin and Fluorouracil in people with Gastric Cancer and Peritoneal Carcinomatosis, run by University of California, Irvine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Paclitaxel, Leucovorin and Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
18 Feb 2021to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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:
  • Ongoing or active infection
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  • Symptomatic congestive heart failure
  • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event,) within 3 months before initiation of treatment
  • Unstable angina pectoris
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868

Other trials in United States

About this study

Official title: 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.

Read the 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).

Keywords
Gastric Cancer, Peritoneal Carcinomatosis, Gastroesophageal Junction (GEJ) Adenocarinoma, Paclitaxel, 5-FU, Fluorouracil, Leucovorin
Medical subject headings
Stomach Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04762953
Study groupRoleWhat they receive
SingleArm: Systemic therapy and IP Paclitaxel in Gastric/GEJ Cancer Peritoneal CarcinomatosisExperimentalPatients 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.
Receives: Drug: Paclitaxel; Drug: Leucovorin; Drug: Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 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 outcomes (2)

  1. Overall Survival of Participants

    To assess the overall survival of participants from the start of systemic treatment to the death from any cause.

    Measured: From initiation of systemic treatment to up to 12 months after last patient is enrolled or until death from any cause.

  2. 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.

    Measured: From initiation of study treatment until patient is off study, assessed up to 12 months after the last patient has started treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2021
  2. Study start18 Feb 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This clinical trial is a non-randomized, open label, single arm clinical trial.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04762953
Sponsor's protocol ID
20206178
Other IDs
UCI 20-87
Acronym
STOPGAP
Status last verified
Jan 2026
First submitted
12 Feb 2021
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Senthil M, Dayyani F. Phase II clinical trial of sequential treatment with systemic chemotherapy and intraperitoneal paclitaxel for gastric and gastroesophageal junction peritoneal carcinomatosis - STOPGAP trial. BMC Cancer. 2023 Mar 4;23(1):209. doi: 10.1186/s12885-023-10680-1.

    PubMed 36870941

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Leucovorin and Fluorouracil in people with Gastric Cancer and Peritoneal Carcinomatosis, run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants with Progression Free Survival at 1-Year (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04762953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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