Gastric and Gastro-oesophageal Junction Adenocarcinoma
Conditions
Interventions
Experimental:Adebelizumab in combination with chemotherapy (up to 6 cycles):
XELOX: Oxaliplatin 130mg/m^2 iv d1 q3w
Capecitabine 1000mg/m^2 po bid d1-14.
Adebrelimab: 1200mg, iv, 30min, q3w.
Maintenance therapy with Adebelizumab until disease progression or intolerable toxicity (up to 2 years).
Sponsors
Affiliated Hospital of Hebei University of Engineering
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age:18 to 80 years old, male or female; 2.Adenocarcinoma of the Gastric and Gastro-oesophageal Junction confirmed by histopathological examination; 3.Locally advanced unresectable, recurrent or metastatic; 4.HER-2 negative; 5.PD-L1 CPS>=5; 6.At least one measurable lesion (according to RECIST 1.1 criteria); 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 8.Expected survival >= 3 months; 9.Normal functioning of major organs, i.e. meeting the following criteria: (1)Blood tests: a.HB >= 90 g/L; b.ANC >= 1.5×10^9/L; c.PLT >= 80×10^9/L; (2)Biochemical examination: a.ALB >= 30g/L; b.ALT and AST = 50%; 11.Women of childbearing potential must have had a negative pregnancy test (serum or urine) within 14 days prior to enrolment and have volunteered to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug; for men, they should have been surgically sterilised or have agreed to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug; 12.Participants were willing to join in this study, good adherence and written informed consent.
Exclusion criteria
Exclusion criteria: 1.Signs of active bleeding from a known lesion (except for positive fecal occult blood); 2.Cardia and pylorus obstruction; 3.HER2 positive; 4.Previous systemic therapy for advanced or metastatic adenocarcinoma of the Gastric and Gastro-oesophageal Junction; 5.Currently participating in an interventional clinical study treatment, or have received another investigational drug or been treated with an investigational device within 4 weeks prior to the first administration of the drug; 6.Known allergy (grade 3 or higher) to any monoclonal antibody or component of a chemotherapeutic agent; 7.Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways; 8.Received live attenuated vaccine within 4 weeks prior to the first dose of study treatment or planned to receive it during the study period; 9.Major surgical procedure (craniotomy, open thoracic or open abdominal surgery) within 4 weeks prior to the first dose of study treatment or anticipation of the need for major surgery during study treatment; 10.Immunosuppressive or systemic hormone therapy for immunosuppression within 14 days prior to initiation of study treatment (dose >10mg/day prednisone or other equipotent hormone); 11.Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose of the drug; 12.Subjects with congenital or acquired immune deficiency (e.g. HIV-infected); 13.In the judgement of the investigator, the subject has other factors that may affect the results of the study or lead to the forced termination of the study, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory abnormalities, accompanied by family or social factors, etc., that would affect the subject's safety; 14.Pregnant or breastfeeding women; 15.History or evidence of disease that may interfere with the results of the trial, prevent the subject from participating in the study in its entirety, abnormal values on treatment or laboratory tests, or other conditions that in the opinion of the investigator make enrolment inappropriate The investigator believes that there are other potential risks that make participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival ;Event-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactCheng Chen
Affiliated Hospital of Hebei University of Engineering
Outcome results
None listed