GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Clinical Trial of Repeated Intraperitoneal Administration of GAIA-102 in Patients With Advanced Gastrointestinal Cancer (Gastric Cancer / Pancreatic Cancer) of Microsatellite Stable (MSS) With Malignant Ascites (Phase I / II Investigator-initiated Clinical Trial) (GAIA-102-PD Clinical Trial)
Kyushu University
176 participants
Jun 8, 2022
INTERVENTIONAL
Conditions
Summary
Phase I Part : Confirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part. Phase II Part(Gastric Cancer):Comparative Study Research the efficacy and safety of as a monotherapy or GAIA-102 and pembrolizumab for advanced gastrointestinal cancer of microsatellite stable with malignant ascites at the recommended dose of GAIA-102 decided in the Phase I part. Phase II Part (Pancreatic Cancer): Comparative Study Including a Run-in Cohort Research the efficacy and safety of a combination regimen of GAIA-102 and pembrolizumab added to existing chemotherapy (standard of care) for microsatellite stable advanced pancreatic cancer with malignant ascites at the recommended dosing frequency of GAIA-102 decided in the Phase I part.
Eligibility
Plain Language Summary
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Interventions
GAIA-102: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 1 to 3 times by weekly for 3 consecutive weeks.
GAIA-102: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 3 times by weekly for 3 consecutive weeks.
Pembrolizumab 200 mg administered on Day 1.
Pembrolizumab 200 mg administered on Day 8.
Trifluridine/tipiracil hydrochloride (FTD/TPI) will be administered orally twice daily for 5 consecutive days, followed by a 2-day rest period. This cycle will be repeated twice, followed by a 14-day rest period. One course consists of this schedule, and the treatment will be repeated in cycles.
Intravenous infusion of 70 mg/m² (based on body surface area) over 90 minutes at 2-week intervals.
Intravenous infusion of 200 mg/m² (based on body surface area) over 2 hours.
Immediately after completion of the calcium levofolinate hydrate intravenous infusion, fluorouracil 400 mg/m² (based on body surface area) will be administered by intravenous injection, followed by a continuous intravenous infusion of fluorouracil 2,400 mg/m² (based on body surface area) over 46 hours.
Locations(1)
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NCT05438459