Advanced HER2-negative gastric cancer with low PD-L1 expression
Conditions
Interventions
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, regardless of gender; 2. Locally advanced inoperable or distant metastatic adenocarcinoma of the stomach or gastroesophageal junction confirmed by pathology; 3. HER2 negative; 4. Have confirmed PD-L1 low expression status (CPS < 5); 5. Have at least 1 measurable lesion meeting RECIST v1.1 criteria; 6. No prior systemic therapy, or neoadjuvant/adjuvant chemotherapy, but disease progression or relapse more than 6 months after the end of treatment; 7. ECOG PS: 0-1 points; 8. Adequate organ function; 9. Expected survival time = 3 months; 10. Women of childbearing age must have taken reliable contraceptive measures or have taken a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive measures during the trial and within 6 months after the last administration of the trial drug. For men, consent to use an appropriate method of contraception during the trial and up to 6 months after the last administration of the trial drug; 11. The study participants voluntarily joined the study and signed the informed consent form, with good compliance and follow-up;
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to any investigational drug and its excipients, or history of severe allergy, or contraindication to the investigational drug; 2. There are cardiovascular and cerebrovascular events that are not well controlled, such as: a. NYHA Grade 2 or higher heart failure; b. unstable angina pectoris; C. Myocardial infarction occurred within 1 years; d. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; e. Cerebral hemorrhage and cerebral infarction (except asymptomatic and untreated lacunar infarction); F. Serious cardiovascular and cerebrovascular events have occurred within 12 months; g. Uncontrollable hypertension, i.e. systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg after monotherapy; h. Patients with a history of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity; i. Stroke or transient ischemic attack within 12 months prior to enrollment; 3. Systemic systemic treatment with ready-for-use traditional Chinese medicine or immunomodulatory drugs with anti-gastric cancer indications (including thymosin, interferon, interleukin, except for topical use to control ascites) within 2 weeks before the first dose; 4. History of interstitial lung disease, non-communicable pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.); 5. Have a history of active immunodeficiency or autoimmune disease, including positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or autoimmune disease; 6. Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection, etc. Patients with a history of active tuberculosis infection = 1 year prior to screening should also be excluded unless evidence can be provided that appropriate treatment has been completed; 7. Presence of brain metastases or pia mater metastases; 8. Clinically significant pleural effusion, pericardial effusion, or ascites requiring multiple drainage within 2 weeks prior to the first dose of study drug; 9. Presence of clinically detectable second primary malignant tumor at the time of enrollment, or other malignant tumors in the past 5 years (except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ); 10. Any major surgical procedure = 28 days prior to the first study drug dose; 11. Prior allogeneic stem cell transplantation or organ transplantation; 12. At present, there are duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation; Or have a history of intestinal perforation or intestinal fistula, but have not recovered after surgical treatment; 13. Have been vaccinated with a live vaccine within 4 weeks (inclusive) before the first dose of study drug; Flu vaccines administered seasonally are usually inactivated vaccines and are therefore allowed; Intranasal vaccine is a live vaccine, so it is not allowed to be used; 14. According to the investigator's judgment, the study participants have other factors that may lead to the forced termination of the study, such as ot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR);Disease control rate (DCR);Objective Response Rate;Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactLian Liu
Qilu Hospital of Shandong University
Outcome results
None listed