New Treatment Modality for Gastric Cancer: Researchers Hail Promising Results from Phase I Trial

Researchers at Erasmus University Medical Center Cancer Institute have made a breakthrough in the treatment of gastric cancer, reporting promising results from a phase I trial of intraperitoneal irinotecan with systemic capecitabine and oxaliplatin. The trial, which involved patients with gastric cancer and peritoneal metastases, demonstrated a median overall survival of 11.8 months, with a safety profile characterized by primarily low-grade adverse events.

Key Takeaways:

• The phase I trial evaluated 3-weekly intraperitoneal irinotecan with oral capecitabine and intravenous oxaliplatin in patients with HER2-negative gastric cancer and macroscopic peritoneal metastases.
• The primary objective was to establish the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs), with the secondary endpoints including safety, pharmacokinetic profile of intraperitoneal irinotecan, and clinical efficacy.
• The median overall survival (OS) was 11.8 months, with a 95% confidence interval of 5.5-18.0 months.
• The exposure to the active metabolite SN-38 was higher intraperitoneally than systemically, with a ratio of 2.1 (range: 0.9-7.4).
• The treatment was well tolerated, with primarily low-grade adverse events, including gastrointestinal toxicity, bone marrow suppression, and peripheral neuropathy.
• A phase II study will commence to assess the feasibility and efficacy of this new treatment modality.
• The researchers concluded that intraperitoneal irinotecan provides a potential new treatment modality for gastric cancer.

Statistics:

• Median overall survival (OS) of 11.8 months (95% CI: 5.5-18.0 months)
• Exposure to active metabolite SN-38 was 2.1 times higher intraperitoneally than systemically (range: 0.9-7.4)
• 6 patients experienced a dose-limiting toxicity in the 50 mg dose cohort, with 2 patients experiencing a DLT in the 100 mg dose cohort, estimating the maximum tolerated dose (MTD) to be 75 mg.
• 11.8 months OS in patients with gastric cancer and peritoneal metastases.

Sources:

• Research paper: Phase I study of intraperitoneal irinotecan with systemic capecitabine and oxaliplatin for patients with gastric peritoneal metastases (2025;191:118491)
• Publisher: Elsevier France-editions Scientifiques Medicales Elsevier
• Address: 65 Rue Camille Desmoulins, CS50083, 92442 Issy-Les-Moulineaux, France
• Contact information: Niels A. D. Guchelaar, Dept. of Medical Oncology, Erasmus University Medical Center, Rotterdam, Netherlands.