Gastric Cancer
Conditions
Interventions
experimental group:SHR-1210 combined with irinotecan and apatinib
Sponsors
Southern Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Local advanced unresectable, recurrent or metastatic adenocarcinoma of the gastric and gastroesophageal junction confirmed by histopathology; 2) Disease progression or intolerable adverse reactions after previous first-line treatment; 3) At least one measurable or evaluable lesion (according to the RECIST 1.1 standard); 4) Patients agreed to provide blood samples and previously stored tumor tissue samples or biopsy to collect tumor tissue for tumor microenvironment detection; 5) Aged 18 - 75 years; 6) ECoG score is 0 or 1; 7) Estimated survival time >= 3 months; 8) The laboratory test values within 7 days before enrollment meet the following standards: 9) Blood routine test: neutrophil count (ANC) >= 1.5 x 10^9 / L, platelet count (PLT) >= 100 x 10^9 / L, hemoglobin (Hgb)>= 80g / L; 10) Liver function: Patients without liver metastasis: TBIL = 50ml / min (calculated according to Cockcroft Gault formula); 12) Coagulation function: international standard ratio (INR) or prothrombin time (PT) < 1.5 times ULN; if the subject is undergoing anticoagulant treatment, Pt should be within the range of anticoagulant drugs; 13) Within 28 days before enrollment, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study drug use and within 6 months after the last administration. If the female spouse of male subjects is of childbearing age, the above contraceptive requirements should also be followed; 14) The patients voluntarily participated in the study, signed the informed consent, and were able to follow the visit and related procedures specified in the program.
Exclusion criteria
Exclusion criteria: 1) At the same time, he participated in other intervention clinical studies (unless he participated in the observation study or was in the follow-up stage of the intervention study), and had received second-line treatment; 2) He has previously received PD-1, PD-L1, PD-L2, CTLA4, CD137 antibody therapy or any other antibody or drug therapy with T cell co stimulation or immunocheckpoint pathway as the specific target; 3) Known allergy to any monoclonal antibody or excipient; 4) Two weeks before the first administration, Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) were received; 5) Major surgery was performed within 4 weeks prior to the first administration or is expected to be performed during the study treatment; 6) Receive live attenuated vaccine within 4 weeks before the first administration or during the study treatment period; Note: it is allowed to receive inactivated vaccine for injection against seasonal influenza within 4 weeks before the first administration, but it is not allowed to receive live attenuated vaccine; 7) Received solid organ or blood system transplantation; 8) Active, known or suspected autoimmune diseases or related medical history in the past 2 years (patients with vitiligo, psoriasis, alopecia or Graves' disease who do not need systematic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement treatment and type I diabetes who only need insulin replacement treatment can be included in the group); 9) Immunosuppressive drugs were used within 4 weeks before the first administration, excluding local glucocorticoids or systemic glucocorticoids of physiological dose (i.e. not more than 10mg / day prednisone or other glucocorticoids of equivalent dose) of nasal spray, inhalation or other routes, or hormones used to prevent the allergy of the imaging agent; 10) Known history of primary immunodeficiency; 11) Known history of active tuberculosis; 12) Known human immunodeficiency virus (HIV) infection history (i.e. HIV antibody positive); 13) Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmias; 14) Prior to the first administration, there was toxicity (excluding alopecia, asthenia and asymptomatic laboratory abnormalities) of level 0 or level 1 (NCI CTCAE version 4.03) caused by previous anti-tumor treatment and not recovered to level 0 or level 1 of general adverse event terminology of the National Cancer Institute; 15) Symptomatic central nervous system metastasis is known; 16) Within 5 years before the first administration, other malignant tumors were diagnosed, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and radical resection of carcinoma in situ; 17) Active infection requiring treatment or systemic anti infective drugs used 7 days before the first administration; 18) Acute or chronic active hepatitis B: HBV load >= 500 copies / ml; 19) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the study; 20) Known presence of mental illness or substance abuse that may affect compliance with test requirements; 21) acute or chronic active hepatitis C: positive for HCV antibody; 22) pregnant or lactating women; 23) there are medical history, disease, treatment or laboratory abnorma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival time; | — |
Countries
China
Contacts
Public ContactShi Min
Southern Hospital of Southern Medical University
Outcome results
None listed