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

Exclusion Criteria31

• 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