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New treatment option for Gastric Cancer
Official title GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
ClinicalTrials.gov ID: NCT05438459
What this study is testing
What is Phase I part?
Phase I part is an investigational medicine, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Unresectable or advanced recurrent gastric cancer with evident peritoneal dissemination on imaging, or with ascites, as well as unresectable or...
- Phase I: Patients with gastric cancer who have received 3 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
You likely can't join if
- Untreated cranial metastases.
- Diagnosed with meningeal carcinomatosis
- Received allogeneic hematopoietic stem cell transplantation
- Participated in other clinical trials / clinical trials within 30 days prior to obtaining written consent and used or had used the investigational...
- Existence or suspected active autoimmune disease
- Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg / day in terms of prednisolone or other immunosuppressants...
See the full eligibility criteria
- 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...
- 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
- Untreated cranial metastases.
- Diagnosed with meningeal carcinomatosis
- Received allogeneic hematopoietic stem cell transplantation
- Participated in other clinical trials / clinical trials within 30 days prior to obtaining written consent and used or had used the investigational product or investigational equipment.
- Existence or suspected active autoimmune disease
- Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg / day in terms of prednisolone or other immunosuppressants within 14 days prior to investigational product administration
- Symptomatic interstitial pneumonia, or even if it is not symptomatic, it may interfere with diagnostic imaging in detecting new pneumonitis caused by the investigational product used in the clinical trial.
- Have active double cancer and need treatment for the double cancer
- Requires treatment as shown in "Unacceptable Combination / Supportive Therapy" during the clinical trial period
- Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment
- Have one of the following complications
- Complication of cerebrovascular disorder with symptoms or history within 6 months before the enrollment
- Active gastrointestinal perforation, fistula, diverticulitis
- Symptomatic congestive heart failure
- Bleeding tendency
- Presence of blood clots that may cause embolism on the image
- Unhealed fractures (excluding compression fractures associated with osteoporosis) or severe wounds requiring medical treatment
- Uncontrollable digestive ulcer
- Active infectious diseases requiring intravenous administration of antibiotics, antifungal agents or antiviral agents
- HIV antibody positive
- At the time of the enrollment, the period from the following prior treatment or the end of treatment has not passed.
- Surgery (including exploratory laparotomy / examination laparoscope): 2 weeks
- Palliative radiotherapy: 1 week
- Thoracic drainage: 1 week
- Pretreatment antineoplastic (from the last administration): 3 weeks
- Biopsy with incision, thoracic biopsy, treatment for trauma (excluding patients without wound healing), etc : 2 weeks
- Scheduled thoracotomy or abdominal surgery during the clinical trial period
- It is judged that it is difficult to enroll in this study due to clinically significant mental illness.
- Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.
- Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)
- Difficult to participate in the trial by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Fukuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.