GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
Sponsor: Kyushu University • ClinicalTrials.gov ID: NCT05438459
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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.
Interventions
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GAIA-102
(Biological)
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.
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GAIA-102
(Biological)
GAIA-102: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 3 times by weekly for 3 consecutive weeks.
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Pembrolizumab
(Drug)
Pembrolizumab 200 mg administered on Day 1.
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Pembrolizumab
(Drug)
Pembrolizumab 200 mg administered on Day 8.
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Trifluridine/tipiracil hydrochloride (FTD/TPI)
(Drug)
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.
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Irinotecan hydrochloride hydrate
(Drug)
Intravenous infusion of 70 mg/m² (based on body surface area) over 90 minutes at 2-week intervals.
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Calcium levofolinate hydrate
(Drug)
Intravenous infusion of 200 mg/m² (based on body surface area) over 2 hours.
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Fluorouracil
(Drug)
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.
Eligibility criteria
Conditions
Locations
- Kyushu University Hospital — Fukuoka, Fukuoka, Japan
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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