Gastric cancer
Conditions
Interventions
Experimental group:Liposomal irinotecan in combination with Adebrelimab and Apatinib
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Adenocarcinoma of the stomach and gastroesophageal junction confirmed by pathology or histology; 3. Negative HER-2 expression; 4. Failure of previous first-line immunotherapy; 5. ECOG PS: 0~2 points; 6. Life expectancy> 3 months; 7. Normal function of major organs, meeting the following requirements (within 7 days prior to starting study treatment): 1) Hemoglobin [HB]>=90g/L; 2) Absolute neutrophil count [ANC] >=1.5×10^9/L; 3) Platelets [PLT]>=100×10^9/L; 4) serum total bilirubin [TBIL] 50ml/min (Cockcroft-Gault formula); 8. Women of childbearing potential must have a negative pregnancy test (serum or urine) result within 7 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last administration of study drug; For males, should be surgically sterile, or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last administration of study drug; 9. Those who are expected to have good compliance can follow up the efficacy and adverse reactions according to the requirements of the protocol; 10. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received irinotecan treatment before; 2. Patients who have previously used apatinib mesylate and patients who have received targeted drug therapy with vascular endothelial growth inhibitors, such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, pazopanib, regorafenib and anlotinib, etc.; 3. Previous use of PD-L1 inhibitors; 4.5 years or concurrently with other active malignancies; 5. Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) Cardiac insufficiency or cardiac ultrasound examination above grade II according to New York Heart Association (NYHA) standards: LVEF (left ventricular ejection fraction) 450ms (male); QTc>470ms (female) (QTc interval calculated by Fridericia's formula; If the QTc is abnormal, it can be tested three times continuously at an interval of about 2 minutes, and the average value can be taken); 6. Patients with hypertension who cannot be reduced to the normal range with antihypertensive medication (systolic blood pressure > = 140 mmHg or diastolic blood pressure > = 90 mmHg) (based on the average of BP readings obtained by > = 2 measurements), which allows the above parameters to be achieved through the use of antihypertensive therapy; 7. Patients with signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding events CTCAE grade 3 within 4 weeks prior to enrollment with unhealed wounds, ulcers, or fractures; 8. Patients with abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN), and bleeding tendency; 9. Urine routine examination showed urine protein ++, and confirmed that the 24-hour urine protein quantification > 1.0g; 10. Severe diarrhea; 11. Subjects with known active hepatitis B (HBsAg positive and HBV DNA >=103 copy number or >=1000 U/ml); 12. Presence of active autoimmune disease or history of autoimmune disease and possible recurrence; 13. Known history of severe allergy to the study drug; 14. Uncontrolled infection or unexplained fever > 38.5°C at screening; 15. Other patients who are considered by the treating physician to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Security; | — |
Countries
China
Contacts
Public ContactWang Mei
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed