What type of study is this?

This is a Human Clinical Trial study (also classified as: Phase 2).

What question did this study set out to answer?

To evaluate the safety and preliminary efficacy of systemic therapy plus intraperitoneal paclitaxel in gastric cancer with peritoneal carcinomatosis.

January 14, 2026

Phase II trial of systemic therapy plus intraperitoneal (IP) paclitaxel (PTX) in gastric/GEJ cancer peritoneal carcinomatosis (GPC): STOPGAP trial.

Key Points

To evaluate the safety and preliminary efficacy of systemic therapy plus intraperitoneal paclitaxel in gastric cancer with peritoneal carcinomatosis.
Single center, single arm, open label phase II trial.
Patients with gastric/GEJ adenocarcinoma and peritoneal involvement receiving IP paclitaxel and systemic therapy.
Treatment included IP paclitaxel, IV paclitaxel, leucovorin, and 5-fluorouracil every 21 days for 4 cycles.
98% of patients completed all 4 cycles of treatment.
Progression-free survival (PFS12) at 28%.
15 patients experienced grade 3 adverse events, primarily anemia.

Abstract

359 Background: Peritoneal carcinomatosis (PC) is a common and deadly metastasis in gastric cancer. Systemic therapy alone may not adequately treat PC due to limited perfusion across peritoneum as result of blood-peritoneal barrier. Hence, combining intraperitoneal (IP) chemotherapy with systemic therapy is a viable alternate strategy to treat PC. We sought to evaluate the safety, feasibility, and preliminary efficacy of iterative normothermic IP PTX plus systemic therapy as consolidation strategy during first-line treatment. Methods: STOPGAP is a single center, single arm, open label phase II trial. Patients (pts) with histology proven gastric/GEJ (Siewert 3) adenocarcinoma with peritoneal involvement and no evidence of visceral metastasis who had no evidence of disease progression after 3-6 months of systemic treatment were eligible. After diagnostic laparoscopy (diag lap), and IP port placement, pts were treated with IP PTX 40 mg/m2 plus IV PTX 50 mg/m2, leucovorin 20 mg/m2 and 5-fluorouracil 400 mg/m2 (bolus) on days1 and 8, every 21 days for 4 cycles. If indicated, anti-PD1 antibody +/- trastuzumab were continued as before enrollment. Pts without progression after 4 cycles underwent repeat diag lap. Pts with peritoneal cancer index (PCI) ≤10 were considered for cytoreduction (CRS) with heated IP chemotherapy (HIPEC). IP PTX was discontinued after CRS. The primary endpoints were safety and feasibility and 12-months progression free survival (PFS12); secondary endpoints included overall survival (OS) and patient- reported outcomes (EuroQol-5D-5L). Results: Between May 2021 and July 2025, 31 pts were enrolled. Median age 50 years, M:F-15:16, median PCI=8 at enrollment (range 0-36); PCI 0 n=4,1-6 n=9, 7-14 n=10, ≥15 n=8. 98% of pts completed all 4 cycles of protocol treatment. G3 AEs occurred in 15 pts (48.3%). The most common AE was anemia (n=7; 21.9%). 11/31(35.4%) pts underwent CRS (CC-0:100%). In CRS cohort, median PCI at enrollment was 6 (0-24) and at CRS was 1 (0-10). No pts had anastomotic leaks or 30-day readmissions. The PFS12 was 28% (95% CI 13%:46%). The median PFS and OS are shown in table. Conclusions: Iterative normothermic IP PTX plus systemic treatment in GPC is safe and feasible, with encouraging clinical efficacy and safety in historically poor risk patients. The ongoing Phase 2/3 EA2234 STOPGAP II randomized trial will investigate the OS benefit of this approach compared to systemic therapy alone. Clinical trial information: 04762953 . Median PFS and OS from diagnosis and on study (months (95% CI). Median PFS from diagnosis Median PFS On study Median OS from diagnosis Median OS On study All patients (n=31) 11.5 (8.3-14.8) 5.1 (3.4-8.1) 17.5 (12.6-19.3) 11.1 (7.7-12.9) No CRS* (n=17) 8.3 (6.9-11.3) 3.4 (2.4-4.9) 13.9 (9.3-16.3) 7.7 (5.0-10.0) CRS** (n=11) 22.2 (11.9-NA ) 18.4 (7.9-NA ) 38 (17.5- NA ) 33.5 (11.7-NA ) *P<0.001 CRS vs. no CRS; **3 pts are awaiting CRS.

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