CLINICAL_TRIALS ClinicalTrials.gov record update

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)

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT05438459
Title field or adapter rule: {'original_value': '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)', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:25.813943+00:00
Published At: 2026-09-15T00:00:00+00:00
Record Updated At: 2026-09-15
Source Retrieved At: 2026-10-31T22:17:56.788771+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Gastric Cancer", "Pancreatic Cancer"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-09-15", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT05438459"
protocolSection.identificationModule.officialTitle: "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)"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1", "PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['Phase I Combination Cohort', 'Phase I Monotherapy Cohort'], 'description': '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.', 'name': 'GAIA-102', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II Gastric Cancer Part: GAIA-102 and Pembrolizumab Combination Group', 'Phase II Pancreatic Cancer Part:GAIA-102 and Pembrolizumab Added to Standard Therapy Group'], 'description': 'GAIA-102: 1 vial (2 x 10\\^8 cells) as dose at a fixed dose, on 3 times by weekly for 3 consecutive weeks.', 'name': 'GAIA-102', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase I Combination Cohort', 'Phase II Gastric Cancer Part: GAIA-102 and Pembrolizumab Combination Group'], 'description': 'Pembrolizumab 200 mg administered on Day 1.', 'name': 'Pembrolizumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II Pancreatic Cancer Part:GAIA-102 and Pembrolizumab Added to Standard Therapy Group'], 'description': 'Pembrolizumab 200 mg administered on Day 8.', 'name': 'Pembrolizumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II Gastric Cancer Part: Ttrifluridine/tipiracil hydrochloride (FTD/TPI)Control Group'], 'description': '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.', 'name': 'Trifluridine/tipiracil hydrochloride (FTD/TPI)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II Pancreatic Cancer Part:GAIA-102 and Pembrolizumab Added to Standard Therapy Group', 'Phase II Pancreatic Cancer Part:Standard Therapy Group'], 'description': 'Intravenous infusion of 70 mg/m² (based on body surface area) over 90 minutes at 2-week intervals.', 'name': 'Irinotecan hydrochloride hydrate', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II Pancreatic Cancer Part:GAIA-102 and Pembrolizumab Added to Standard Therapy Group', 'Phase II Pancreatic Cancer Part:Standard Therapy Group'], 'description': 'Intravenous infusion of 200 mg/m² (based on body surface area) over 2 hours.', 'name': 'Calcium levofolinate hydrate', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['Phase II Pancreatic Cancer Part:GAIA-102 and Pembrolizumab Added to Standard Therapy Group', 'Phase II Pancreatic Cancer Part:Standard Therapy Group'], 'description': '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.', 'name': 'Fluorouracil', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

A recorded drug name is not by itself an indication or a condition-specific relationship.

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