Locally advanced or metastatic gastric adenocarcinoma
Conditions
Interventions
The group treated with candelinibant:Kadcyla (AK104) in combination with SOX
The group treated with tislelizumab:Tislelizumab combined with SOX
Sponsors
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Before implementing any trial-related procedures, sign the written informed consent form. 2.Male or female, aged 18 years or older and no more than 75 years old; 3.Histologically confirmed gastric adenocarcinoma was diagnosed as locally advanced stage according to the 8th edition of AJCC. It was diagnosed as unresectable locally advanced or metastatic gastric adenocarcinoma based on ultrasound endoscopy or enhanced CT/MRI scans (combined with ultrasound gastroscopy and diagnostic laparoscopy exploration when necessary). 4.Those who have not received systematic treatment for the current disease before are eligible to join the study if they have been free from postoperative adjuvant therapy for more than 6 months. 5.ECOG score of 0-1 points; 6.According to the RECIST 1.1 criteria, there should be at least one measurable lesion; 7.Expected survival time >= 3 months; 8.Adequate organ functions are required for the subjects to meet the following laboratory indicators: 1) Within the past 14 days, without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) should be >= 1.5 x 10^9/L; 2) Within the past 14 days, without blood transfusion, the platelet count should be >= 100 × 10^9/L; 3) Within the past 14 days, without blood transfusion or using erythropoietin, the hemoglobin should be > 9 g/dL; 4) Total bilirubin should be = 60 ml/min; 7) Good coagulation function, defined as the international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; 8) Normal thyroid function, defined as the thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) Cardiac enzyme spectrum should be within the normal range (such as if the study investigator determines that it is a purely laboratory abnormality without clinical significance, it is also allowed to enroll). 9.For the female subjects of childbearing age, they should undergo urine or serum pregnancy tests within 3 days before the administration of the first study drug (on the first day of the 1st cycle), and the results should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-pregnant women are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy. 10.If there is a risk of conception, all subjects (regardless of gender) are required to adopt contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of the chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1.Within five years prior to the first administration, other malignant diseases were diagnosed except for gastric cancer (excluding skin basal cell carcinoma and/or squamous cell carcinoma that have undergone radical cure, and/or carcinoma in situ that has undergone radical resection); 2.It is known that endoscopic examination reveals signs of active bleeding in the lesion. 3.Currently participating in an interventional clinical trial for treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first administration of this drug. 4.The patient has received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another type of stimulatory or synergistic inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 5.Within 2 weeks prior to the first administration, received systemic and systemic treatment with traditional Chinese medicine or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally for controlling pleural effusion) with anti-tumor indications; 6.Within 2 years prior to the first administration, there has been occurrence of active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants). Therapies that are alternative to systemic treatment (such as thyroid hormone, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency) are not regarded as systemic treatment. 7.The study excluded subjects who were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first administration; Note: Administration of physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent drugs) was allowed. 8.Known cases of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9.Known cases of allergy to the drugs used in this study. 10.Those with multiple factors influencing tegafur-oguacitinib (such as inability to swallow and intestinal obstruction, etc.); 11.Before commencing the treatment, there was no sufficient recovery from the toxicities and/or complications caused by any intervention measures (i.e., <=grade 1 or reaching the baseline, excluding fatigue or alopecia); 12.It is known that the history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 13.Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected to be greater than the upper limit of normal value in the laboratory of the research center where the test was conducted); 14.Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 15.Before the first administration (during the 1st cycle, on the 1st day), having received live vaccines within 30 days prior to that.Note: It is permitted to receive the injectable inactivated virus vaccine for seasonal influenza within 30 days before the first administration; however, intranasal attenuated live influenza vaccine is not allowed. 16.Pregnant or lactating women; 17.There exists any serious or uncontrollable systemic disease. 18.There may be medical history or disease evidence, abnormal values of treatment or laboratory tests, or other situations tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS);Overall survival;Safety;Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactGuihua Wang
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed