# GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites

Source: https://onco.cc/trials/nct05438459/  
OnCo record `nct05438459` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Tags: ctgov-ingest; pancreatic-deep-dive
- Registry id: 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

## Sources

- ClinicalTrials.gov NCT05438459: https://clinicaltrials.gov/study/NCT05438459

## Connected records

- cancers: [Locally advanced unresectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/locally-advanced-pdac/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Trifluridine/tipiracil](https://onco.cc/drugs/trifluridine-tipiracil/)
- terms: [Pancreatic cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/pancreatic-trials-open-today/)

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