Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)

NCT07795749 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY00001075UCI 25-190
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

Esophageal Carcinoma; Gastric Cancer (Diagnosis); Colorectal Adenocarcinoma; Appendiceal Adenocarcinoma; Small Bowel Adenocarcinoma; Hepatobiliary Carcinoma in Situ

Outcome Measures

Primary Outcomes (1)

• Protocol Treatment Completion Rate

  Number of patients that complete treatment at 2 cycles

  6 weeks

Secondary Outcomes (5)

• Overall Survival of Participants

  3 years

• Participants with Progression Free Survival

  3 years

• Patient Reported Quality of Life Outcomes

  1 year

• Incidence of Treatment-Emergent Adverse Events [Safety]

  1 year

• Overall Response Rate (ORR) by RECIST v1.1

  1 year

Study Arms (6)

CohtAQ2W: Chort A Gastric/Esophageal Carcinoma (Paclitaxel Q2W)

EXPERIMENTAL

Drug: Paclitaxel Q2W

CohtAQ3W: Cohort A Gastric/Esophageal Carcinoma (Paclitaxel Q3W)

EXPERIMENTAL

Drug: Paclitaxcel Q3W

CohtBQ2W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q2W)

EXPERIMENTAL

Drug: Paclitaxel Q2W

CohtBQ3W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q3W)

EXPERIMENTAL

Drug: Paclitaxcel Q3W

CohtCQ2W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q2W)

EXPERIMENTAL

Drug: Paclitaxel Q2W

CohtCQ3W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q3W)

EXPERIMENTAL

Drug: Paclitaxcel Q3W

Interventions

Paclitaxel Q2W DRUG

Given IP-IV, every 2 weeks

CohtAQ2W: Chort A Gastric/Esophageal Carcinoma (Paclitaxel Q2W); CohtBQ2W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q2W); CohtCQ2W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q2W)

Paclitaxcel Q3W DRUG

Given IP-IV, every 3 weeks

CohtAQ3W: Cohort A Gastric/Esophageal Carcinoma (Paclitaxel Q3W); CohtBQ3W: Cohort B Colorectal/Appendiceal Adenocarcinoma (Paclitaxel Q3W); CohtCQ3W: Cohort C Other Malignancies of the Digestive Tract (Paclitaxel Q3W)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Disease; Adenocarcinoma, Mucinous

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Study Officials

• Maheswari Senthil, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839; ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Division Chief - Surgical Oncology

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 4, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)