Esophageal CarcinomaPhase 2NCT07795749
Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)
A Phase 2 study testing Paclitaxel Q2W and Paclitaxcel Q3W in people with Esophageal Carcinoma and Gastric Cancer (Diagnosis), run by University of California, Irvine at 1 site in United States.
Trial summary
This is a phase II open-label, basket clinical trial to assess the feasibility of systemic and Intraperitoneal chemotherapy in subjects with Gastrointestinal Malignancies with Peritoneal Carcinomatosis. These are subjects who have a proven primary carcinoma of the digestive tract.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma, Gastric Cancer (Diagnosis), Colorectal Adenocarcinoma
- What is being tested?
- Paclitaxel Q2W and Paclitaxcel Q3W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to 31 Aug 2029
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Maheswari Senthil, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Phase II Basket Trial of Intraperitoneal Paclitaxel Plus Systemic Therapy in Gastrointestinal Malignancies With Peritoneal Carcinomatosis (STOPGAP - B)
This is a phase II open-label, basket clinical trial to assess the feasibility of systemic and Intraperitoneal chemotherapy in subjects with Gastrointestinal Malignancies with Peritoneal Carcinomatosis. These are subjects who have a proven primary carcinoma of the digestive tract..
- Conditions
- Esophageal Carcinoma, Gastric Cancer (Diagnosis), Colorectal Adenocarcinoma, Appendiceal Adenocarcinoma, Small Bowel Adenocarcinoma, Hepatobiliary Carcinoma in Situ
- Being tested
- Paclitaxel Q2W, Paclitaxcel Q3W
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Disease, Adenocarcinoma, Mucinous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Q2WDrug
Given IP-IV, every 2 weeks
Paclitaxcel Q3WDrug
Given IP-IV, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CohtAQ2W: Chort A Gastric/Esophageal Carcinoma (Paclitaxel Q2W) | Experimental | Not described Receives: Drug: Paclitaxel Q2W |
| CohtAQ3W: Cohort A Gastric/Esophageal Carcinoma (Paclitaxel Q3W) | Experimental | Not described Receives: Drug: Paclitaxcel Q3W |
| CohtBQ2W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q2W) | Experimental | Not described Receives: Drug: Paclitaxel Q2W |
| CohtBQ3W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q3W) | Experimental | Not described Receives: Drug: Paclitaxcel Q3W |
| CohtCQ2W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q2W) | Experimental | Not described Receives: Drug: Paclitaxel Q2W |
| CohtCQ3W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q3W) | Experimental | Not described Receives: Drug: Paclitaxcel Q3W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Treatment Completion Rate
Number of patients that complete treatment at 2 cycles
Measured: 6 weeks
Secondary outcomes (5)
Overall Survival of Participants
To assess the overall survival of participants from the start of systemic treatment to the death from any cause.
Measured: 3 years
Participants with Progression Free Survival
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: 3 years
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: 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.
Measured: 1 year
Overall Response Rate (ORR) by RECIST v1.1
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start4 Aug 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maheswari Senthil, MD, University of California, Irvine
- Investigators
- Maheswari Senthil, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795749
- Sponsor's protocol ID
- STUDY00001075
- Other IDs
- UCI 25-190
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No