Gastric Cancer
Conditions
Interventions
Immunotherapy rechallenge group:Adebrelimab +Apatinib + Irinotecan
Sponsors
Renji 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.Histologically or cytologically confirmed gastric adenocarcinoma, locally advanced and unresectable, local recurrence (local lymph node metastasis) or distant metastasis; 3. Progression on or were intolerant to first-line immunochemotherapy: (1)Patients were also eligible if they progressed during initial chemotherapy, or if patients with postoperative recurrence or metastasis progressed during concurrent chemoradiotherapy. (2)For neoadjuvant /adjuvant immunotherapy, if patients progress during the treatment or within six months after treatment, it is considered as a failure of first-line treatment (3)Patients who discontinuation of prior anti-PD-1/PD-L1 immunotherapy due to adverse immune reactions were also eligible. Patients must not experience any grade 3 or more severe immune-related adverse event (irAE). Any unresolved grade 2 irAE. Any toxicity that lead to permanent discontinuation of previous immunotherapy. 4. At least one measurable lesion (according to RECIST 1.1) 5. ECOG:0~1; 6.Expected survival time =3 months; 7.Adequate function of major organs; 8.Women of childbearing age should consent to take contraception measures during the study period and within 6 months after the study ends. Female subjects must be negative serum or urine pregnancy test within 7 days before the recruitment. Female subjects must be non-lactating women. Men should consent to contraception during the study period and for 6 months after the end of the study; 9.All subjects were recruited and signed informed consent on a voluntary basis and were willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study. 10. HER2 was negative based on IHC.
Exclusion criteria
Exclusion criteria: 1.Have any active autoimmune disease or a past history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, etc.); 2.Currently receiving immunosuppressors or systemic hormone therapy for immunosuppressors purposes (dose =10mg/ day, prednisone or other equivalent hormone) and continued use within 2 weeks before recruitment; 3.Patients received treatment with VEGFR inhibitors, such as sorafenib, Sunitinib, Apatinib, etc.; 4. Any of the following conditions that will interfere with oral medications: unable to swallow, having received gastroenterostomy, chronic diarrhea and intestinal obstruction; 5.Patients with any serious and/or uncontrollable medical condition, including: poor blood pressure control (systolic pressure =150 mmHg or diastolic pressure=100 mmHg); having myocardial ischemia or myocardial infarction and arrhythmia of Grade 1 and above (including QT interval = 480 ms) and cardiac insufficiency of Grade 1; Active or uncontrolled severe infection; Liver diseases, such as decompensated liver failure, active hepatitis B (HBV-DNA=104 copy number /mL or 2000 IU/mL), or hepatitis C (positive anti-HCV antibody, HCV-RNA above the lower limit of detection by assay); Urine routine examination indicated urinary protein =++ and confirmed 24-hour urinary protein quantification>1.0 g; 6.Wounds or fractures that have not healed for a long time; 7.Has a tendency to bleed (e.g. active peptic ulcer) or is currently receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or its analogues; 8. Patients who have had an arterial/venous thrombotic event within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism; 9.The probability of tumor invasion of important blood vessels or tumor invasion of important blood vessels is high based on radiological examination, which may lead to fatal bleeding during future study; 10.Pregnant or breastfeeding; 11. Patients with a history of other malignant tumors in the past 5 years (except cured basal cell carcinoma and cervical carcinoma in situ); 12. Patients with a history of psychotropic drug abuse and addiction or mental disorders; 13. Patients who have participated in clinical trials of other drugs in the past 4 weeks; 14. A concomitant disease determined by the investigator to seriously compromise the patient's safety or prevent the patient from completing the study; Other patients deemed unsuitable for participation; 15. Other patients who are considered inappropriate for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactZhang Zizhen; Xia Xiang
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed