A Phase I Clinical Study for Evaluating the Safety of MASCT-I in Advanced Soild Tumor

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring MASCT-I Read More

Inclusion Criteria:

• The age is 18-70 years old.
• The written informed consent of the patient / legal representative is obtained before any program related implementation.
• Metastatic or non resectable, locally advanced gastric or gastroesophageal adenocarcinoma, confirmed by histology or cytology.
• The development of objective imaging after first-line chemotherapy (RECIST1.1);
• There were measurable lesions (according to RECIST1.1);
• Can provide tumor tissue specimens;
• PDL1 positive (only for the second, third stage) or MSI test positive;
• Time interval to last chemotherapy is at least 1 month.
• 0-1 ECOG score
• The expected survival time is more than 4 months
• Peripheral blood cell culture showes the proliferation of lymphocytes

Exclusion Criteria:

• Participate in the plan or implementation of the research (including staff of HRYZ and the staff of the research center);
• Participate into other clinical studies at the same time, unless it is an observational (non - intervention) clinical study;
• Subjects may receive other systemic antitumor treatment during the study.
• Squamous or undifferentiated gastric cancer
• There were active bleeding, ulcers, gastrointestinal perforation, fistula, or arterial embolism in the gastrointestinal tract within 6 months.
• There were clinically significant gastrointestinal bleeding or venous thrombosis in three months before enrollment.
• End-stage cachexia patients;
• Patients with severe coagulation dysfunction;
• Patients with extensive abdominal adhesions;
• Patients with intestinal obstruction;
• Pregnancy or planned pregnancy;
• Refusing to provide blood specimens;
• Hypersensitivity to sodium citrate;
• Subjects have received allogeneic transplantation
• Subjects had clinical symptoms of central nervous system metastasis (such as brain edema, requiring hormone intervention, or progression of brain metastases)
• Subjects are using immunosuppressive agents, or whole body or absorbable local hormone therapy to achieve the aim of immunosuppression (dose >10mg/ days prednisone or other therapeutic hormones) and continue to use in the first 2 weeks before enrollment.
• Systemic or long-term application of immunomodulators, such as interferon, thymosin, and immunosuppressive drugs, in half a year.
• Subjects had been treated with MASCT or other cellular immunotherapy within a year.
• Subjects had any active autoimmune disease or a history of autoimmune disease.
• Active tuberculosis
• There is a big operation in 30 days before the first study treatment.
• Patients with active hepatitis B virus (HBV) infection (chronic or acute)
• The infection of active hepatitis C virus (HCV)
• Suffering from human immunodeficiency virus (HIV) or syphilis
• A history of peripheral nervous system disorder or a history of obvious mental disorders and central nervous system disorders
• Subjects had active infection or >38.5 degree of unexplained fever in the screening period and before the first administration.
• Chronic systemic diseases, such as liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease, or non controlled diabetes, hypertension, etc.
• There were other malignant tumors in 5 years, except for non melanin skin cancer and cervical carcinoma in situ
• There are heart symptoms or diseases that have not been well controlled.
• Subjects were known to have a history of psychotropic drug abuse, alcoholism, or drug abuse.
• According to the researchers, there are other factors that may lead to a halt.