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)
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 : 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.
• Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.
• Refractory/intolerant to more than 3 regimens of therapy for gastric cancer (more than 2 regimens acceptable for Phase II) or more than 2 regimens of therapy for pancreatic cancer (more than 1 regimen acceptable for Phase II)
• Abdominal port placement is possible
• No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
• Diagnosed gastric adenocarcinoma or pancreatic cancer with by histological or cytological examination
• The patient has been confirmed to be negative (not MSS = MSI-high) by microsatellite instability (MSI) testing, or proficient mismatch repair (pMMR) by mismatch repair protein immunohistochemistry testing
• Eastern Cooperative Oncology Group (ECOG) Performance status(PS) 0-2
• Patient aged 20years or older
• Adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function:
‣ Neutrophil \>1,500/mm3
⁃ hemoglobin \>=8.0 g/dL
⁃ Platelet \>75,000/mm3
⁃ PT-INR \<1.5
⁃ AST, ALT \<=3 times the upper limit of reference value
⁃ T-Bil \<=2 times the upper limit of reference value (T-Bil \<=3.0mg/dL , when drainage for obstructive jaundice)
⁃ eGFR \>=30mL/min/1.73m2
⁃ Expected to survive for 3 months or more at the enrollment
⁃ Written informed consent