Paclitaxel given inside the abdomen with systemic therapy for GI cancers with peritoneal spread
Official title: Phase II Basket Trial of Intraperitoneal Paclitaxel Plus Systemic Therapy in Gastrointestinal Malignancies With Peritoneal Carcinomatosis (STOPGAP - B)
Run by University of California, Irvine · NCT07795749 · Data updated 2026-11-12
This phase II study tests a combination of intraperitoneal and systemic chemotherapy (paclitaxel) in adults with digestive tract cancers that have spread to the peritoneum.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | University of California, Irvine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Orange, California) |
| Status | Recruiting |
| Started | August 4, 2026 |
| Main results expected | August 31, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07795749 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with histologically confirmed GI cancer and peritoneal carcinomatosis, stratified into cohorts A-C based on primary site, with no need for upfront CRS in the serositis cohort.
✕Probably not a fit
Patients without peritoneal disease improvement or with disease progression despite therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase II, open-label basket trial enrolling adults with primary GI cancers and peritoneal carcinomatosis. The study uses paclitaxel both intraperitoneally and systemically on a defined schedule to see if this approach is feasible and tolerable. Participants are grouped into cohorts based on cancer type (gastric/GEJ, colorectal/appendiceal, and other GI adenocarcinomas with peritoneal disease). Key eligibility requires confirmed GI cancer with peritoneal involvement, measurable disease or cytology positive peritoneal disease, and adequate organ function. The study is conducted at the Chao Family Comprehensive Cancer Center, UC Irvine, led by UC Irvine researchers.
Why it matters
Potential benefit: If successful, this approach could provide a new option for controlling peritoneal disease and potentially improve symptoms or survival.
How similar studies have gone: Previous similar strategies have shown partial feasibility and activity in peritoneal carcinomatosis, but this specific intraperitoneal plus systemic paclitaxel approach in a basket design is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cohort A: Patients must have histologically or cytologically confirmed primary gastric or gastroesophageal adenocarcinoma with a clinical diagnosis of metachronous PC with a history of prior gastric cancer resection. Extraperitoneal metastases are allowed. * Cohort B: Patients must have histologically or cytologically confirmed primary colorectal or appendiceal adenocarcinoma with PC . Extraperitoneal metastases are allowed. Patients with PC amenable to cytoreductive surgery (CRS) without the need for upfront systemic therapy as determined by a peritoneal malignancy surgeon within 4 weeks prior to enrollment are excluded. * Cohort C: Patients must have adenocarcinomas of the digestive tract with PC not included in Cohorts A and B (including but not limited to carcinomas of the small bowel and hepatobiliary tract). * Must have peritoneal cytology positive disease or peritoneal carcinomatosis detected by imaging, laparoscopy or laparotomy * Age ≥ 18 * Performance status: ECOG performance status ≤ 2 (Appendix A) . ECOG 2 allowed if attributed to malignancy (rather than comorbidities) * Life expectancy of greater than 3 months * Adequate organ and marrow function as defined below: Leukocytes: ≥ 2,000/mcL; Absolute neutrophil count: ≥ 1,500/mcL (may receive gcsf); Platelets: ≥ 70,000/mcl (may receive TPO); Total bilirubin: within 2x of normal institutional limit; AST(SGOT)/ALT(SPGT): ≤5 X institutional upper limit of normal; Creatinine: \< 2 X institutional upper limit of normal; Hemoglobin: Hemoglobin \> 8.0 g/dL (may be transfused); Serum albumin: ≥ 2.5 g/dL * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * 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; 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. * History of prior iterative intraperitonealtherapy administered either as HIPEC, PIPAC or NIPEC. Single exposure to HIPEC at the time of cytreduction is not an exclusion * 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.
Where it's running
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Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States Recruiting
Study contacts
- Principal investigator: Maheswari Senthil, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.