[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100575532","phase-1-phase-i-study-of-bc008-1a-injection-in-patients-with-advanced-solid-tumors-100575532",false,"NCT06773507","Phase I Study of BC008-1A Injection in Patients With Advanced Solid Tumors","An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics and Preliminary Efficacy of BC008-1A Injection in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Cohort 1:\n\n   Patients with inoperable, locally advanced or metastatic esophageal squamous cell carcinoma confirmed by histopathology or cytology. Those who have failed standard treatment or have no effective standard treatment available; Patients can provide the results of PD-L1 expression status within 1 year or agree to provide archived pathological tissues or fresh tissues within 1 year for testing.\n\n   Cohort 2:\n\n   Patients with non-small cell lung cancer (squamous cell carcinoma and adenocarcinoma) confirmed by histology or cytology, who have failed standard treatment or have no effective standard treatment available; Patients can provide archived pathological tissues or fresh pathological tissues within 1 year for PD-L1 testing, and the PD-L1 Tumor Proportion Score (TPS) ≥ 1%.\n2. Sign a written informed consent form before any study-specific procedures and be able to follow the visit schedules and related procedures stipulated in the protocol.\n3. Male or female patients aged ≥ 18 years old.\n4. Expected survival time ≥ 12 weeks.\n5. According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), there should be at least one measurable tumor lesion shown by CT or MRI examination (lesions that have not received radiotherapy before). If a lesion located in the irradiated area that has received radiotherapy previously clearly shows progression meeting the RECIST 1.1 criteria, such lesion can be regarded as a measurable lesion.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status score is 0 or 1.\n7. Have sufficient hematopoietic, liver and kidney functions and meet the following laboratory test results before enrollment (no use of any cell growth factors, platelet or red blood cell transfusions, etc. within 1 week before the first dose of study treatment):\n\n   Basically normal hematopoietic system: Absolute Neutrophil Count (ANC) ≥ 1.5 × 109\u002FL, Platelet (PLT) ≥ 90 × 109\u002FL, Hemoglobin (Hb) ≥ 90 g\u002FL; Basically normal liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN (for subjects with liver metastases, Total Bilirubin ≤ 2.5 × ULN), Alanine Transaminase (ALT) ≤ 2.5 × ULN, Aspartate Transaminase (AST) ≤ 2.5 × ULN (for subjects with liver metastases, ALT ≤ 5 × ULN, AST ≤ 5 × ULN), Alkaline Phosphatase ≤ 2.5 × ULN (for subjects with liver or bone metastases, Alkaline Phosphatase ≤ 5 × ULN), Plasma Albumin (ALB) ≥ 28 g\u002FL; Basically normal kidney function: Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); Basically normal coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN or Prothrombin Time (PT) ≤ 1.5 × ULN or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator judges that INR, PT and APTT are all within the safe and effective treatment range without clinical conditions of active bleeding or increased bleeding risk).\n8. Female subjects of childbearing age or male subjects whose partners are women of childbearing age must take effective contraceptive measures throughout the treatment period and within 6 months after the treatment period.\n\nExclusion Criteria:\n\n1. Having been previously exposed to any anti-TIGIT drugs.\n2. Currently participating in another interventional clinical study, except for participation in observational (non-interventional) clinical studies or being in the survival follow-up stage of an interventional study.\n3. Having received any investigational drugs within 4 weeks prior to the first administration of the study drug.\n4. Having an autoimmune disease or a history of autoimmune diseases or related symptoms.\n5. Having received the last anti-tumor treatment within 4 weeks before the first administration of the study drug: systemic chemotherapy (the washout period for oral fluorouracil drugs is 2 weeks, and that for mitomycin C and nitrosourea drugs is 6 weeks), endocrine therapy, targeted therapy (the washout period for small molecule targeted therapy is 2 weeks or 5 half-lives, whichever is longer), immunotherapy, tumor embolization or treatment with traditional Chinese herbal medicines with anti-tumor indications, etc.\n6. Having been treated with corticosteroid drugs or other immunosuppressive agents within 4 weeks before the first administration of the study drug.\n7. Having received a live attenuated vaccine within 4 weeks before the first administration of the study drug or planning to receive it during the study period.\n8. Having toxicity that has not recovered to grade 0 or 1 according to the NCI-CTCAE v5.0 caused by previous anti-tumor treatment within 4 weeks before the first dose of study treatment (excluding alopecia, fatigue or vitiligo), having unstable neuropathy or \\> grade 2 neuropathy induced by previous anti-tumor treatment, including having unresolved immune-related adverse events (irAE) after receiving immunotherapy and those who have experienced irAE ≥ grade 3.\n9. Having a history of pneumonia requiring steroid treatment, or having interstitial lung disease (including both past and present medical history).\n10. Currently having an active infection (e.g., acute bacterial infection, tuberculosis, active hepatitis B\u002Fhepatitis C, pulmonary infection, etc.).\n11. Known to have central nervous system (CNS) metastasis and\u002For spinal cord compression and\u002For carcinomatous meningitis, or having a history of leptomeningeal carcinoma.\n12. Being positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and having HBV DNA higher than the upper limit of the normal value of the study center, or being judged by the doctor to have active hepatitis, being infected with hepatitis C virus (HCV), or being positive for human immunodeficiency virus (HIV) antibody, or being positive for Treponema pallidum antibody (Tp-Ab).\n13. Having poorly controlled cardiac clinical symptoms or diseases, such as uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris or having had a myocardial infarction within 6 months before enrollment in the trial, or having poorly controlled arrhythmia (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women, with the QTc interval calculated by the Fridericia formula), etc.\n14. Having a cardiac function classification (NYHA) of grade III or IV, and having a left ventricular ejection fraction (LVEF) \\\u003C 50% at rest.\n15. Having suffered from other malignant tumors within five years (except for completely cured or curable cancers, such as basal cell skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, or any type of carcinoma in situ that has been completely resected, such as carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, etc.).\n16. Being allergic to the components or excipients of the experimental drug, antibody drugs or any other therapeutic proteins (such as fresh frozen plasma, human serum albumin, cytokines or interleukins, etc.), or having a severe allergy history, or being suspected of having a severe allergic reaction (NCI-CTCAE v5.0 ≥ grade 3).\n17. Having a history of alcoholism, drug addiction or drug abuse within 1 year before screening.\n18. Having a clear history of neurological or psychiatric disorders in the past, such as epilepsy, dementia, or being poorly compliant.\n19. Pregnant or lactating women.\n20. Other circumstances that the investigator deems unsuitable for participation in this study.","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this study is to learn if BC008-1A given 900mg or 1200mg intravenously once every 3 weeks is safe and effective to treat patients with advanced esophageal cancer or advanced non-small cell lung cancer. It will also learn about the safety and pharmacokinetics of BC008-1A.",[26,27],"Advanced Esophageal Cancers","Advanced Non-small Cell Lung Cancer (NSCLC)",[29,30,31,32],"PD-1","TIGIT","Esophageal Cancer","non-small cell lung cancer","RECRUITING","2025-07-07",{"date":36,"type":37},"2025-07-09","ACTUAL",{"date":39,"type":37},"2025-05-12",{"date":41,"type":20},"2027-06",{"name":43,"class":44},"Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100575530","phase-1-bc008-1a-injection-for-recurrent-cns-who-g4-glioma-100575530","NCT06773481","BC008-1A Injection for Recurrent CNS WHO G4 Glioma","A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Subjects With Recurrent CNS WHO Grade 4 Glioma.","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form;\n2. Recurrent CNS WHO grade 4 glioma: Subjects with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment and have no surgical plan;\n3. Male or female aged ≥ 18 years old;\n4. Expected survival time ≥ 12 weeks;\n5. According to the RANO criteria, there is at least one measurable intracranial tumor lesion;\n6. KPS ≥ 70;\n7. Have sufficient hematological function, liver function and renal function, and meet the following laboratory test results before enrollment (withoutusing any cell growth factors, platelet and red blood cell transfusion or other blood transfusion treatments within 1 week before the first dose of study treatment):\n\n   * Basically normal liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN (patients with known Gilbert disease with serum bilirubin level ≤3 × ULN can be included), alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN;\n   * Basically normal renal function: Creatinine (Cr) ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin;\n   * Basically normal coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant treatment, the investigator judges that INR, PT and APTT are within the safe and effective treatment range and there is no clinical condition of active bleeding or increased bleeding risk);\n   * Basically normal hematological system: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (without granulocyte colony-stimulating factor treatment), platelet (PLT) ≥ 100 × 10\\^9\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL, white blood cell count ≥ 2.0 × 10\\^9\u002FL, lymphocyte count ≥ 0.5 ×10\\^9\u002FL.\n8. Female subjects of childbearing age or male subjects whose partners are women of childbearing age need to agree to take effective contraceptive measures during the trial period (from signing the ICF to 6 months after the last dose).\n\nExclusion Criteria:\n\n1. Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs;\n2. Having suffered from other malignant tumors and currently requiring treatment (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin that have been adequately treated);\n3. Having an autoimmune disease or a history of autoimmune diseases or related symptoms;\n4. Subjects who cannot undergo MRI (such as those with a pacemaker implanted, non-removable metal dentures, claustrophobia, etc.);\n5. Subjects who have received chemotherapy (those who have used nitrosourea drugs within 42 days before the first receipt of the experimental drug cannot be enrolled), radiotherapy, biotherapy, endocrine therapy, targeted therapy, tumor-treating fields therapy, immunotherapy or other anti-tumor treatments such as anti-tumor Chinese patent medicines within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter), or subjects who have received any clinical study treatment and the interval from the first use of the study drug is ≤ 28 days;\n6. Subjects with tumor lesions involving the brainstem, spinal cord or leptomeningeal dissemination and metastasis;\n7. Those who have used corticosteroids within 1 month before participating in the trial and have received systemic treatment with a daily dose higher than 3 mg of dexamethasone or an equivalent dose of other hormones;\n8. The toxicity caused by previous anti-tumor treatments has not decreased to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities judged by the investigator to have no safety risks, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.);\n9. Those who have received live attenuated vaccines within 4 weeks before the first administration of the study drug or plan to receive them during the study period;\n10. Subjects with active infections at present (such as acute bacterial infections, tuberculosis, pulmonary infections, etc.);\n11. Those who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and whose HBV DNA is higher than the upper limit of the normal value of the site, or those judged by doctors to have active hepatitis, hepatitis C virus (HCV) infection, or those who are positive for human immunodeficiency virus (HIV) antibody, or those who are positive for Treponema pallidum antibody (Tp-Ab);\n12. Those with cardiac clinical symptoms or diseases that are not well controlled, such as uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris or myocardial infarction occurring within 6 months before enrollment in the trial, or poorly controlled arrhythmias (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women, with the QTc interval calculated by the Fridericia formula), etc.;\n13. Cardiac function classified as grade III or IV according to the New York Heart Association (NYHA) classification;\n14. Those who are allergic to the components or excipients of the experimental drug, antibody drugs or any other therapeutic proteins (such as fresh frozen plasma, human serum albumin, cytokines or interleukins, etc.), or those with a history of severe allergies and suspected to have severe allergic reactions (NCI-CTCAEv5.0 ≥ grade 3);\n15. Those with a clear history of neurological or mental disorders in the past, such as dementia, and with poor compliance;\n16. Those with epilepsy and\u002For increased intracranial pressure that are difficult to control by drugs;\n17. Pregnant or lactating women;\n18. Other situations that the investigator deems unsuitable for participating in this study.",{"count":54,"type":20},40,[23],"The purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.",[58,59,60,61,62],"Glioma","Glioma Tumor Recurrence","Glioma, Recurrent High Grade","Glioblastomas (GBM)","Glioblastoma WHO Grade IV",[64,29,30,65,66],"glioma","bispecific antibody","glioblastoma",{"date":36,"type":37},{"date":69,"type":37},"2025-04-07",{"date":71,"type":20},"2026-12",{"name":43,"class":44},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100575517","phase-1-bc001-in-combination-with-sintilimab-and-xelox-in-the-treatment-of-her-2-negative-advanced-or-metastatic-gastric-cancer-or-gastroesophageal-junction-adenocarcinoma-100575517","NCT06773312","BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of BC001 in Combination with Sintilimab and XELOX in the Treatment of HER-2 Negative Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC\u002FGEJ).","Inclusion Criteria:\n\n1. Subjects must be able to understand and voluntarily sign the written informed consent.\n2. Subjects must be willing and able to complete the study procedures and follow-up examinations.\n3. Male or female subjects aged between 18 and 75 years old (including 18 and 75 years old).\n4. HER-2 negative patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC\u002FGEJ) (according to the 8th edition of AJCC\u002FUICC TNM staging) confirmed by histopathology or cytopathology, who have never received systemic treatment before (the time interval from the end of previous neoadjuvant treatment\u002Fadjuvant treatment to the recurrence of the disease \\> 6 months will be regarded as untreated).\n5. According to RECIST version 1.1, there must be at least one measurable tumor lesion shown by CT or MRI examination.\n6. Subjects with normal oral intake.\n7. ECOG (Eastern Cooperative Oncology Group) performance score of 0 - 1.\n8. Expected survival period is greater than 3 months.\n9. There is no serious hematological, hepatic or renal function abnormality, meeting the following laboratory test results: the absolute neutrophil count (ANC) should be ≥1.5×10⁹\u002FL, platelet (PLT) ≥100×10⁹\u002FL, and hemoglobin (HGB) ≥90g\u002FL; Serum creatinine (Cr) ≤1.5× the upper limit of normal range (ULN). When Cr \\> 1.5×ULN, , and creatinine clearance rate (Ccr)≥ 60mL\u002Fmin(calculated according to the Cockcroft - Gault formula); the qualitative urine protein should be ≤1 +, or if the qualitative urine protein ≥2 +, the 24-hour urine protein \\\u003C 1g; total bilirubin (TBIL) ≤1.5×ULN or ≤3×ULN (for patients with liver cancer or liver metastases), alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤3.0×ULN or ≤5×ULN (for patients with liver cancer or liver metastases), alkaline phosphatase (ALP) ≤2.5×ULN or ≤5×ULN (for patients with liver cancer or liver metastases); the international normalized ratio (INR) or prothrombin time T (PT) ≤1.5×ULN, and the activated partial thromboplastin time (APTT) ≤1.5×ULN.\n10. Male or female subjects should take effective contraceptive measures during the treatment period and within 6 months after the last dose administration.\n\nExclusion Criteria:\n\n1. Subjects who have undergone major organ surgical operations (excluding needle biopsy) or had significant trauma within 4 weeks prior to the first use of the study drug, or who need to undergo elective surgeries during the trial period.\n2. Subjects whose original lesions have invaded the central nervous system (CNS) with symptoms, are unstable or require high-dose steroids (≥10mg dexamethasone or equivalent dose) to achieve control.\n3. Subjects suffering from other primary malignancies, except for malignancies with low metastasis risk and low death risk (5-year survival rate \\> 90%), such as malignancies that have been cured and have not relapsed within 3 years before enrollment in the study; completely resected basal cell and squamous cell skin cancers; completely resected carcinomas in situ of any type.\n4. Subjects with active infections (such as viral, bacterial or fungal infections) that require systemic treatment.\n5. Subjects currently suffering from interstitial lung disease (except for radiation-induced pulmonary fibrosis that does not require hormone treatment).\n6. Subjects with a history of active bleeding within the past 4 weeks or at risk of gastrointestinal perforation, or with a history of recent surgeries that have not healed or with a history of wound complications caused by surgical operations.\n7. Subjects who had gastrointestinal bleeding within 3 months prior to the use of the study drug and without evidence verified by endoscopy or colonoscopy that they have recovered; subjects with severe gastrointestinal diseases within 2 weeks prior to the use of the study drug.\n8. Subjects with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: Having severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, grade II - III atrioventricular block, etc.; Having suffered from acute coronary syndrome, congestive heart failure, aortic dissection, stroke\u002FTIA or other grade 3 or above cardiovascular and cerebrovascular events within 6 months prior to the first dose administration; Having heart failure of New York Heart Association (NYHA) class \\> II or left ventricular ejection fraction (LVEF) \\\u003C 50%; Having a baseline QTcF interval corrected for heart rate calculated by the Fridericia formula \\> 450 msec (for males) and \\> 470 msec (for females); Having any factors that increase the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or using any concomitant drugs known to prolong the QT interval.\n\n   Having a diastolic blood pressure ≥ 100 mmHg or a systolic blood pressure ≥ 160 mmHg after standardized treatment.\n9. Subjects who have received treatments such as colony-stimulating factors and erythropoietin within 2 weeks prior to the use of the study drug.\n10. Subjects who have been vaccinated with live vaccines within 4 weeks prior to the use of the study drug. Live vaccines include but are not limited to the following: measles, mumps, rubella, varicella\u002Fzoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG) and typhoid vaccines. Seasonal influenza vaccines for injection are usually inactivated virus vaccines, so their use is permitted; intranasal influenza vaccines (e.g., FluMist) are attenuated live vaccines and are not permitted for use.\n11. Subjects who are currently receiving long-term treatment with non-steroidal anti-inflammatory drugs (such as indomethacin, ibuprofen, etc.) or antiplatelet drugs (such as clopidogrel, ticlopidine, dipyridamole, etc.) (the use of aspirin is permitted with a maximum daily dose of 325mg).\n12. Subjects with a known history of liver diseases of significant clinical significance, including active hepatitis (hepatitis B surface antigen positive and the copy number of HBV DNA \\> the normal value of the testing unit; hepatitis C virus antibody positive and the copy number of HCV RNA \\> the normal value of the testing unit), hepatic encephalopathy, hepatorenal syndrome, liver function at Child-Pugh grade B or more severe cirrhosis.\n13. Subjects with a history of human immunodeficiency virus infection or suffering from other acquired or congenital immunodeficiency diseases.\n14. Subjects who are preparing for or have previously received tissue\u002Forgan transplantation.\n15. Subjects known to be allergic to the study drugs, monoclonal antibodies and other therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukins, etc.).\n16. Subjects known to have alcohol and\u002For drug dependence.\n17. Female subjects with a positive blood pregnancy test or those who are breastfeeding.\n18. Subjects with known signs of active bleeding in the lesions.\n19. Subjects with pleural effusion, pericardial effusion or ascites that are uncontrollable and require repeated drainage or medical intervention. Only those with a small amount of ascites shown by imaging but without symptoms can be enrolled.\n20. Subjects known to have dihydropyrimidine dehydrogenase (DPD) deficiency (or those who have experienced grade 3 or above mucosal toxicity during previous fluorouracil-containing treatments).\n21. Subjects with cardiac obstruction, pyloric obstruction or persistent and repeated vomiting (defined as vomiting ≥ 3 times within 24 hours).\n22. Subjects who had intestinal obstruction or the following diseases within 3 months prior to the first use of the study drug: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection accompanied by chronic diarrhea), Crohn's disease, ulcerative colitis.\n23. Subjects with a history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment; subjects who need to use vitamin K antagonists for anticoagulation or need to use heparin at a therapeutic dose (prophylactic dose is acceptable) during the study period.\n24. Subjects who need to use systemic immunosuppressive therapy within 14 days prior to the first use of the study drug or during the study period, except for the following situations: intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injection); physiological doses of systemic corticosteroids (≤10mg\u002Fday prednisone or equivalent dose); short-term (≤7 days) use of steroids for the prevention or treatment of non-autoimmune allergic diseases.\n25. Subjects judged by the researcher as being unsuitable for participating in this study for other reasons.","75 Years",{"count":19,"type":20},[23],"The goal of this clinical trial is to learn the efficaty and safety of BC001 in combination with Sintilimab and XELOX in treating patients with advanced or metastatic GC\u002FGEJ.\n\nParticipants will:\n\nBe administered with BC001, Sintilimab and Oxaliplatin once every three weeks for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.\n\nTake Capecitabine once daily in the first two weeks of each three-week treatment cycle for up to 24 months or until disease progression as per RECIST 1.1 or withdrawal from this study.",[85,86],"Advanced or Metastatic Gastric Cancer","Gastroesophageal Junction Adenocarcinoma",[88,89,90],"gastroesophageal junction adenocarcinoma","VEGFR2","gastric cancer","2025-03-07",{"date":93,"type":37},"2025-03-10",{"date":95,"type":37},"2025-02-28",{"date":97,"type":20},"2027-04",{"name":43,"class":44},""]