gastric or gastroesophageal junction adenocarcinoma
Conditions
Interventions
Experimental group:Adebrelimab, Apatinib, Oxaliplatin, Tigio
Sponsors
Beijing Friendship Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years, expected lifespan > 6 months; 2. Patients diagnosed with gastric cancer or gastroesophageal junction cancer by pathology or cytology, with histological examination confirming primarily adenocarcinoma; 3. Patients diagnosed by doctors as having unresectable gastric or gastroesophageal junction adenocarcinoma using preoperative examinations such as CT, MRI, PET-CT; 4. Patients with unresectable gastric or gastroesophageal junction adenocarcinoma that have potential for conversion therapy, defined as single organ metastasis (e.g., liver metastasis, ovarian metastasis, lung metastasis), retroperitoneal lymph node metastasis, supraclavicular lymph node metastasis, localized peritoneal metastasis, invasion of surrounding organs, and other gastric or gastroesophageal junction adenocarcinoma patients assessed by researchers for feasible conversion therapy; 5. Patients who have not received prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 6. ECOG (Eastern Cooperative Oncology Group) score of 0 to 2; 7. Major organ functions are normal, with no severe blood, heart, lung, liver, kidney dysfunction, or immunodeficiency diseases Laboratory tests meet the following requirements: Hemoglobin >= 90g/L - White blood cells (WBC) >= 3.5×10^9/L Absolute neutrophil count (ANC) >= 1.5×10^9/L Platelets >= 100×10^9/L - ALT, AST <= 2.5 times the upper limit of normal, <= 5 times the upper limit of normal (for those with liver metastasis) Serum total bilirubin <= 1.5 times the upper limit of normal Serum creatinine <= 1.5 times the upper limit of normal 8. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result, and voluntarily use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug; for men, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug; 9. Patients voluntarily join this study and sign the Informed Consent Form (ICF); 10. Expected to have good compliance, able to follow up on efficacy and adverse reactions as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with a positive HER-2 test; 2. It has a variety of factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 3. Known hypersensitivity to adebelimab, apatinib mesylate, oxaliplatin and tigio or drug excipients; or have had a severe allergic reaction to other monoclonal antibodies; or intolerant to radiotherapy toxicity; 4. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); Patients with complete remission of childhood asthma who do not require any intervention in adulthood or vitiligo may be included, but patients requiring medical intervention with bronchodilators are not included; 5. Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBVDNA>=500IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and hepatitis C; 6. Use of immunosuppressive medications, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones at physiologic doses, within 14 days prior to the first dose of study drug; 7. Vaccination with live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study; 8. Concurrent severe infection (e.g., need for intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks prior to the first dose, or unexplained fever > during screening/before the first dose38.5°C; 9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10. There is objective evidence that there is previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.; 11. Patients with hypertension who cannot be reduced to the normal range after 3 months of antihypertensive drug treatment (systolic blood pressure class II.); Unstable or severe angina; Acute myocardial infarction within 6 months; Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; left ventricular ejection fraction (LVEF) 30ml), hemoptysis (bleeding within 4 weeks>5ml) and thromboembolic events (including stroke events and/or transient ischemic episodes) within 12 months; 14. Presence of symptoms of peripheral neuropathy of grade > 2; 15. Participated in other clinical trials or participated in any other drug clinical studies within 4 weeks, or no more than 5 half-lives from the last study drug; 16. Other situations that the investigator deems inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;Adverse Events (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Overall survival (OS);Disease Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactWei Deng
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed