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)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or advanced recurrent pancreatic cancer.

• Phase I:

• Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.

• Phase II:

• Patients with gastric cancer who have received 2 or more prior chemotherapy regimens, including at least 1 regimen containing an immune checkpoint inhibitor, and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 1 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.

• 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

• The Eastern Cooperative Oncology Group (ECOG) performance status(PS) at the time of informed consent meets the following conditions.

‣ Phase I :0-2

⁃ Phase II :0-1

• 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

Locations
Other Locations
Japan
Kyushu University Hospital
RECRUITING
Fukuoka
Contact Information
Primary
Eiji Oki
oki.eiji.857@m.kyushu-u.ac.jp
+81-92-642-5479
Time Frame
Start Date: 2022-06-08
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 130
Treatments
Experimental: GAIA-102 as a monotherapy
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.
Experimental: GAIA-102 and pembrolizumab in combination
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.~Pembrolizumab:200 mg on Day 1.
Experimental: Ttrifluridine/tipiracil hydrochloride (FTD/TPI) as the standard therapy group
Trifluridine/tipiracil hydrochloride (FTD/TPI) : 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.
Sponsors
Collaborators: GAIA BioMedicine Inc., Toho University - Omori Medical Center, Teikyo University Hospital, Kyushu Cancer Center, Kindai University Hospital, Kansai Medical University Hospital, Jichi Medical University
Leads: Kyushu University

This content was sourced from clinicaltrials.gov

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