advanced gastric cancer
Conditions
Interventions
advanced gastric cancer group:L60c injection 1x10^6/kg~1x10^7/kg
Sponsors
Shanxi Provincal Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 and =80 years old, gender is not limited; 2. Life expectancy =3 months; 3. The Eastern Oncology Consortium (ECOG) peformance status from 0 to 1; 4. Archived tumor tissue or newly obtained biopsy tissue samples can be provided (at least 5 formalin-fixed paraffin-embedded tissue blocks or at least 10 unstained fresh sections); 5. Subjects with malignant gastric/esophagogastric junction adenocarcinoma confirmed by pathological diagnosis(who have failed in previous treatment(s), or disease progression after systematic treatment, unable to tolerate during treatment, or who are currently in appropriate to receive standard treatment), and the CLDN18.2 positive rate of tumor tissues in IHC stainning is =40%. 6. Subjects should voluntarily receive peripheral blood mononuclear cell (PBMCs) apheresis collection. 7. At least one or more measurable lesions (CT slice thickness = 5 mm, maximal diameter = 10 mm, and lymph node with malignant metastasis minimal diameter of =15 mm) according by RECIST 1.1. 8. No serious hematological, hepatic, and renal function abnormalities, adequate function defined as : ? Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days) : Neutrophil count (ANC) =1.5x10^9/L, Platelet (PLT) =75x10^9/L, Hemoglobin (Hb) =80g/L, Lymphocyte count (LYM) = 60%xlower limit of normal value; ? Hepatic function: Total bilirubin (TBIL) =1.5xULN Alanine aminotransfer (ALT) =2.5xULN, aspartate aminotransfer (AST) =5xULN of patients with liver metastasis Creatinine =1.5xULN or creatinine clearance eGFR =60 mL/min; ? Blood coagulation function : Activated partial thrombin time (APTT) =1.5xULN International normalized ratio (INR) =1.5xULN; 9. Eligible subjects (male or female ) must comply with effective contraception methods (hormonal or barrier method or abstinence, etc.) during the trial period at least 90 days after L60c injection; Female subjects of childbearing potential (definition refers to appendix) must undergo a pregnancy test (blood or urine) and the results must be negative within 7 days prior to first use of L60c injection. 10. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with symptomatic and/or untreated brain metastases (of any size and number); However, subjects may be eligible if they received documented treatment, and the intractanial lesion(s) remain stable for at least 14 days before screening; 2 Subjects suffered form other malignant tumors or concurrent malignancy within two years prior screening, except for basal cell skin cancer that has been cured, and in situ malignancies of cervical carcinoma or lung cancer; 3. Subjects received treatment with tirelizumab (excluding other PD-1 monoclonal antibodies) or any PD-L1 monoclonal antibody within the first 12 weeks of screening; 4. Subjects received systemic chemotherapy, radiotherapy, immunotherapy and targeted therapy within 2 weeks before screening; However, the restrtiction for Nitroso urea or Mitomycin C are within 6 weeks before screening; 5. Subjects received chronic systemic sex hormone treatment for any reason within 12 weeks before screening; However, the use of low-dose glucocorticoid replacement therapy due to adrenal cortex dysfunction is exempted. 6. Subjects received granulocyte Colony-stimulating factor (G-CSF) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) for leukotherapy within 12 weeks before screening; 7. Subjects recived with Claudin18.2-targeted drug treatment previously; 8. Any active autoimmune disease or autoimmune disease in history, which is included but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; and asthma requiring medical intervention by bronchiectasis, etc., except for vitiligo, psoriasis and alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement therapy; 9. Recipients of any organ transplant, including allogeneic stem cell transplants, with exception of transplants requiring no immunosuppression (e.g, corneal transplants, hair transplants); 10. Subjects with any forms of primary immunedeficiency (e.g, severe combined immunodeficiency disease [SCID] and acquired immunodeficiency syndrome [AIDS]) 11 Presence of major acute or chronic infections, including: ? Viral hepatitis, including hepatitis B (HBsAg positive and/or hepatitis B DNA copy number higher than the lower detection threshold of the research center) ? Hepatitis C, etc; HIV antibody test positive; Patients with positive Treponema pallidum antibodies; ? Active bacterial or fungal infections that require systemic treatment; ? Active tuberculosis infection withclinical symptoms, physical examination or imaging, and laboratory findings; 12 Acute exacerbation of chronic obstructive pulmonary disease or other respiratory diseases; 13 Cardiovascular/Cerebrovascular disease with clinical significance, such as cerebrovascular accident/stroke (300mg/d or clopidogrel>75mg/d, etc.); 18 Pregnant or lactating women; 19 Subjects with no/limited capacity for civil conduction, or mental disorders/ poor comp
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Duration of response; | — |
Primary
| Measure | Time frame |
|---|---|
| adverse events;L60c gene copy number in peripheral blood;cytokines;3 months-Objective response rate;3 months-Disease control rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactLi Ning
Shanxi Provincal Cancer Hospital.
Outcome results
None listed