{"entity":{"id":"nct05438459","kind":"trial","name":"GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites","aka":[],"tldr":"A phase 1/2 trial of pembrolizumab, trifluridine/tipiracil and fluorouracil (5-FU) in pancreatic cancer, run by Kyushu University, now recruiting.","summary":"GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites is a phase 1/2, randomised interventional study registered as NCT05438459 by Kyushu University, with a registry enrolment figure of 176 participants, started 2022-06-08 and due to reach its primary completion in 2032-03-31. Interventions recorded: GAIA-102; GAIA-102; Pembrolizumab; Pembrolizumab; Trifluridine/tipiracil hydrochloride (FTD/TPI); Irinotecan hydrochloride hydrate; Calcium levofolinate hydrate; Fluorouracil. Conditions listed: Gastric Cancer; Pancreatic Cancer. Primary outcome: Number of participants of Dose Limiting Toxicity (DLT) with GAIA-102 (Phase I); Frequency and severity of adverse events(Phase I); Overall survival in patients with gastric cancer (Phase II). Pancreatic eligibility wording from the registry: \"* Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with malignant ascites, as well as unresectable or advanced recurrent pancreatic cancer\". Sites: Japan. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05438459","url":"https://clinicaltrials.gov/study/NCT05438459"}],"tags":["ctgov-ingest","pancreatic-deep-dive"],"related":[],"cancers":["locally-advanced-pdac","metastatic-pdac"],"sections":[],"technologies":["checkpoint-inhibitor","cytotoxic-chemotherapy"],"targets":[],"drugs":["pembrolizumab","trifluridine-tipiracil","fluorouracil"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05438459","phase":"1/2","setting":"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)","sponsor":"Kyushu University","enrolled":176,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05438459/","neighbours":{"cancer":[{"id":"locally-advanced-pdac","kind":"cancer","name":"Locally advanced unresectable pancreatic ductal adenocarcinoma","route":"/cancers/locally-advanced-pdac/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"id":"trifluridine-tipiracil","kind":"drug","name":"Trifluridine/tipiracil","route":"/drugs/trifluridine-tipiracil/"}],"term":[{"id":"pancreatic-trials-open-today","kind":"term","name":"Pancreatic cancer trials open today (registry snapshot and UK sites)","route":"/terms/pancreatic-trials-open-today/"}]}}