Gastric Cancer
Conditions
Interventions
Test group:PDT + SOX regimen + Apatinib + PD-1 inhibitor, PDT + SOX regimen
Control group:SOX regimen + Apatinib + PD-1 inhibitor, SOX regimen
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed/or clinically diagnosed advanced inoperable gastric adenocarcinoma; 2) Previously receiving or not receiving standard chemotherapy or targeted therapy or immunotherapy; 3) Age = 18 years and not more than 75 years old; 4) Expected survival = 3 months; 5) ECOG score of 0-1; 6) at least one measurable tumour lesion with a long diameter of =10 mm and a short lymph node diameter of =15 mm on spiral CT or a maximum diameter of =20 mm on plain CT or physical examination; 7) no major organ failure; 8) no serious coagulation disorders; 9) can tolerate electronic gastroscopy; 10) Voluntarily enrolled in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with known hypersensitivity to photosensitisers and synthetic monoclonal antibodies or immunosuppressive agents; 2) patients who cannot tolerate local photodynamic surgery or egastroscopy; 3) Patients who have received prior monoclonal antibody therapy and have developed grade 2 or higher irAE; 4) Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months prior to the start of study treatment; 5) Patients with any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (with hormone replacement therapy may be included)); patients with childhood asthma that has been in complete remission and does not require any intervention in adulthood or with vitiligo may be included, and patients who require bronchodilator medical intervention may not be included. Patients who are not eligible for inclusion; 6) patients with congenital or acquired immune deficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (hepatitis C antibody positive with HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and hepatitis C; 7) Patients with severe hepatic encephalopathy; 8) those with significant coagulation mechanism disorders, active bleeding and bleeding tendency; 9) History of other malignant tumours within 5 years (other than adequately treated basal cell carcinoma of the skin and cervical carcinoma in situ); 10) Patients with severe uncontrolled medical illnesses, acute infections, recent history of myocardial infarction (within 3 months) and patients unable to tolerate oncology drugs; 11) Complicated severe infections (e.g., requiring intravenous antibiotics, antifungal or antiviral medications) within 4 weeks prior to the first dose, or unexplained fever >38.5°C during the screening period/prior to the first dose; 12) Pregnancy or breastfeeding, and fertile individuals who refuse to use adequate contraception during the course of this trial; 13) Any condition which, in the opinion of the investigator, may be detrimental to the subject or cause the subject to be unable to fulfil or perform the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| object remission rate;disease control rate;Progression-free survival;Complete remission rate;median overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactHao Chen
Lanzhou University Second Hospital
Outcome results
None listed