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STOPGAP II: Intraperitoneal Paclitaxel in Gastric Carcinomatosis
NCT07001748Phase 3
Key facts
- Status
- Recruiting
- Start
- Oct 2025
- Primary completion
- May 2030
- Countries
- 1
- Sponsor
- ECOG-ACRIN Cancer Research Group
- Conditions
- gastric adenocarcinomagastroesophageal junction adenocarcinomaperitoneal carcinomatosis (PC)
01
Overview
Phase 3, randomised, open-label trial of Paclitaxel Micelles for Injection in gastric adenocarcinoma, gastroesophageal junction adenocarcinoma and peritoneal carcinomatosis (PC) (2 arms), sponsored by ECOG-ACRIN Cancer Research Group. Primary endpoints: Progression-Free Survival up to 5 years and Overall Survival up to 5 years. Started Oct 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard systemic therapy
Standard of care systemic therapy per physician's choice.
Systemic Therapy + Intraperitoneal Paclitaxel
Intraperitoneal port placement followed by IV leucovorin, IV fluorouracil, IV paclitaxel, and IP paclitaxel on days 1 and 8 of 21-day cycles.
03
Who it enrols
Adult patients with MSS/MMR proficient gastric or GEJ adenocarcinoma with peritoneal carcinomatosis who have received 3-6 months of first-line systemic therapy without progression, and have adequate organ function.
04
Endpoints
Primary
Progression-Free Survival
Overall Survival
Secondary
Incidence of Adverse Events
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