[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gcgejc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gcgejc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,72,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100645253","phase-1-phase-ibiia-open-label-study-to-evaluate-safety-tolerability-and-antitumor-activity-of-hcb101-in-combination-with-multiple-agents-in-subjects-with-advanced-gastric-or-gastro-esophageal-gej-adenocarcinoma-100645253",false,"NCT07680569","Phase Ib\u002FIIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Gastric or Gastro-esophageal (GEJ) Adenocarcinoma","HCB101 GC GEJ","Inclusion Criteria:\n\n1. Subjects are able to understand and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, including study visits and study-related procedures.\n2. Male and female subjects of ≥18 years of age, inclusive, at the time of signing the informed consent.\n3. With histologically\u002Fcytologically confirmed diagnosis of advanced gastric and gastro-esophageal adenocarcinoma as described below:\n\n   • Unresectable locally advanced, or metastatic HER2 (-) gastric or GEJ adenocarcinoma cancer, whose tumors are CLDN 18.2 positive (defined as ≥ 75% of tumor cells demonstrating moderate to strong membranous CLDN 18.2 immunohistochemical staining using an FDA-approved test ( http:\u002F\u002Fwww.fda.gov\u002FCompanionDiagnostics).\n4. Must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n5. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at Screening.\n6. Have a life expectancy of ≥12 weeks (according to the Investigator's judgment).\n7. Have adequate organ function, as indicated by the following laboratory parameters below (had not received a blood transfusion, apheresis infusion, erythropoietin, granulocyte colony-stimulating factor, and other relevant medical support within 14 days before the administration of the first dose of study intervention).\n\n   1. Absolute neutrophil count ≥1.5 × 109\u002FL\n   2. Platelets ≥100 × 109\u002FL\n   3. Hemoglobin ≥9.0 g\u002FdL\n   4. Total bilirubin ≤1.5 × upper limit of normal (ULN), \\\u003C3.0 × ULN if known Gilbert's disease\n   5. Alanine aminotransferase and aspartate aminotransferase ≤3× ULN and ≤5× ULN for subjects with liver metastasis\n   6. Creatinine clearance ≥30 mL\u002Fmin (using Cockcroft Gault equation)\n   7. Coagulation: International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5× ULN (The INR applies only to subjects who do not receive therapeutic anticoagulation)\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test during the Screening Period (within 7 days before the first dose of the study intervention).\n9. Subjects must have tumors that are not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).\n10. Subjects must not have received any prior systemic anti-cancer and immune checkpoint inhibitor therapy.\n\nExclusion Criteria:\n\n1. Medical Conditions:\n\n   1. With a known history of hypersensitivity to any components of the study intervention.\n   2. Subjects who have other malignancies requiring treatment within 2 years before the first dose of study intervention will be excluded, except for radically treated locally curable basal or squamous cell skin cancer and other malignancies that have been treated with no relapse within 2 years.\n   3. Primary tumor in the central nervous system (CNS), or active or untreated CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate, provided they are clinically stable for at least 28 days and have no evidence of new or enlarging brain metastases and no requirements for high-dose corticosteroids 14 days before dosing with study intervention. Subjects on low-dose corticosteroids (\\\u003C20 mg prednisone or equivalent per day) may participate.\n   4. Clinically significant cardiovascular condition, including\n\n      1. History of congestive heart failure (New York Heart Association Class \\>2), with only heart failure with preserved ejection fraction (HFpEF) included;\n      2. History of unstable angina within 6 months before the first dose of study intervention;\n      3. New-onset angina or myocardial infarction within 6 months before the first dose of study intervention;\n      4. New-onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within 6 months before the first dose of study intervention and still in unstable condition and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed, provided the condition is stably controlled.\n   5. History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QT interval corrected for heart rate using Fridericia's correction \\[QTcF\\] \\>470 msec at Screening, pacemaker installation, or previous diagnosis of congenital long QT syndrome).\n   6. Any previous treatment-related toxicities which have not recovered to ≤ Grade 1 as evaluated by National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 or baseline, except alopecia and anemia (Note: subjects with chronic Grade 2 toxicities which are well managed and stable may be eligible per the discretion of the Investigator, e.g., Grade 2 chemotherapy-induced neuropathy.)\n   7. With known inherited or acquired bleeding disorders or bleeding diathesis.\n   8. Have RBC transfusion dependence defined as requiring more than 2 units of RBC transfusions every 28 days over a period of 3 months before Screening.\n   9. With a previously documented diagnosis of hemolytic anemia or Evans Syndrome in the last 3 months.\n2. Prior\u002FConcomitant Therapy\u002FTreatment\n\n   1. Subjects who have undergone major surgery or radical radiotherapy within 28 days before the first dose of study intervention.\n   2. Subjects who have undergone palliative radiotherapy within 14 days before the first dose of study intervention.\n   3. Subjects who have used a radioactive drug (Strontium, Samarium, etc.) within 56 days before the first dose of the study intervention.\n   4. Subjects who have undergone any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy, and herbal\u002Falternative therapies with anti-cancer indications or targeted therapy) within 14 days or 5 half-lives, whichever is longer, before the first dose of the study intervention.\n   5. Subjects who have used herbal medication within 14 days before the first dose of the study intervention.\n   6. Subjects who are active using of vitamin K antagonist anticoagulant like warfarin. Use of low molecular weight heparin and factor Xa inhibitors will be permitted on a case-by-case basis. Daily low dose of aspirin use (≤ 100 mg\u002FQD) is allowed.\n   7. Subjects who have received any treatment targeting the CD47 or SIRPα pathway.\n3. Participation in another clinical study with an investigational product administered in the last 14 days or 5 half-lives (whichever is longer) before receiving the first dose of study intervention. An investigational device was used within 28 days before the first dose of study intervention.\n4. Reproductive and breastfeeding\n\n   1. Women of reproductive potential who are unable to use effective contraception during treatment and for 6 months after the last dose.\n   2. Women who are breastfeeding during treatment and for 6 months after the last dose.\n5. Infections:\n\n   1. An uncontrolled acute infection, an active infection requiring systemic treatment, or subjects who have received systemic antibiotics within 14 days before the first dose of the study intervention (Note: prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as there is no violation of the requirement of concomitant medications).\n   2. Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome or positive HIV testing having CD4+ T-cell counts \\\u003C350 cells\u002FµL or subjects with unknown HIV infection status who are unwilling to undergo HIV testing.\n   3. Known active hepatitis B or C. Subjects with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during Screening must be further tested for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) titer (excluding subjects with a DNA titer of more than 2500 copies \\[cps\\]\u002FmL or 500 IU\u002FmL) and HCV ribonucleic acid (RNA) (excluding subjects with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, i.e., subjects with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 cps\u002FmL or 500 IU\u002FmL) and hepatitis C infected subjects who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled. Note: If the lower detection limit of the HBV DNA assay is higher than 2500 cps\u002FmL or 500 IU\u002FmL, the subjects with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled.\n   4. Active tuberculosis or latent tuberculosis infection (LTBI).\n6. Known to have a history of alcoholism or drug abuse.\n7. Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the Investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.\n8. Subjects with current pneumonitis or a history of severe pneumonitis, including but not limited to immune-related pneumonitis or radiation-induced pneumonitis.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is an open-label, dose-escalation and dose-expansion phase Ib\u002FIIa clinical study to evaluate the safety, tolerability, and preliminary efficacy of HCB101 in combination therapies in subjects with gastric or GEJ adenocarcinoma. A total of about 40 subjects will be enrolled in this study.\n\nPart-I: Dose-Escalation Phase (Phase Ib)\n\nThis phase includes Screening, Treatment, and Follow-up Periods:\n\nScreening Period: Screening period is up to 28 days (D-28 to D-1) prior to receiving the first dose of HCB101.\n\nTreatment Period: This period includes repeat dosing treatment period (42 days per cycle). During the treatment period, subjects from different cohorts will receive HCB101 in combination therapy. Treatment will continue until one of the following occurs: unacceptable adverse event (AE), radiographic or clinically documented disease progression, withdrawal of consent, loss to follow-up, death, or termination of the study, whenever occurs first.\n\nFollow-up Period: This period will include Safety and Survival Follow-up Visits. After the last dose in the study, subjects are required to undergo a Safety Follow-up Visit, which will take place 30 (±7) days after the last dose of HCB101, and they will also undergo the Survival Follow-up Visit every 8 weeks (±14 days).\n\nThe end of treatment (EOT) Visit will coincide with the subject has permanently terminated the study intervention. If the EOT Visit is performed within the time window for the Safety Follow-up Visit, re-examination is not required.\n\nDose Escalation Criteria The study includes four planned dose levels of HCB101(8 mg\u002Fkg, 12 mg\u002Fkg, 18 mg\u002Fkg and 24 mg\u002Fkg) The maximum tolerated dose (MTD) will be determined using the standard 3+3 method.\n\nTo enhance safety during dose escalation, a staggered dosing approach will be applied. The second subject in each dose level should receive treatment staggered by at least 5 days after the first subject has received the 1st dose, provided that no significant safety concerns have been observed.\n\n1. Dose Escalation: The trial begins with the lowest dose, escalating in a stepwise manner. The observation period for dose limiting toxicities (DLT) is from the start of the first dose to day 28 post-dose. The next dose cohort may proceed only after the previous cohort has completed the 28-day DLT observation period and it is confirmed that the subjects are safely tolerated.\n2. Initial Cohort: Each dose cohort initially enrols three subjects. If none of these three subjects experience a DLT during the observation period, the next dose cohort will be enrolled.\n3. One DLT in a Cohort (1\u002F3): If one out of three subjects experience a DLT, an additional three subjects will be enrolled at that dose level, totally six subjects.\n\n1\\) Two or More DLTs (2+\u002F6): If one or more of the additional three subjects experience a DLT (resulting in two or more DLTs at this dose level), dose escalation will stop, and the previous dose will be designated as the MTD, or the SRC may decide to use an intermediate dose for further investigation.\n\n2\\) No Additional DLTs (1\u002F6): If none of the additional three subjects experience a DLT (resulting in one DLT out of six), the trial will proceed to the next higher dose level.\n\n4\\) Two or More DLTs in a Cohort (≥2\u002F3): If two or more out of three subjects experience a DLT, dose escalation will conclude, and the previous dose will be considered the MTD, or the SRC may determine whether to use an intermediate dose for the next level of investigation.\n\n5\\) \\*Maximum Dose Level: If the dose escalation reaches the highest level of 24 mg\u002Fkg without establishing an MTD, the MTD and\u002For the (potential) RP2D or effective dose may be confirmed based on safety, tolerability and efficacy data obtained. Additionally, it may be decided whether new dose levels are required for further escalation studies.\n\nAfter all subjects in each dose level have completed the DLT assessment, the SRC will decide whether to proceed with dose escalation, explore intermediate\u002Fhigher doses, terminate the dose escalation study, proceed with a dose extension study or adjust the tumor type for dose extension, etc., based on the data obtained on safety, tolerability and antitumor activity (if required), etc. The SRC may also adjust the dose and frequency of administration, etc.; the SRC may also decide during a dose escalation whether to adjust the tumor type enrolled. Based on the provision of a reasonable basis, appropriate methods may be used to combine the pre-adjustment data with the post-adjustment data, or with data obtained from studies conducted by HCB101.\n\nDuring the dose-escalation phase, if a subject does not experience a Grade ≥ 2 AE related to the trial treatment (including HCB101 or in combination with standard-of-care drugs), intra-subject dose escalation is permitted after the DLT evaluation period. A maximum of two intra-individual dose escalations per subject is allowed.",[27],"GC\u002FGEJC",[29,30,31],"HCB101","GC","GEJC","NOT_YET_RECRUITING","2026-07-01",{"date":35,"type":36},"2026-07-02","ACTUAL",{"date":38,"type":20},"2026-06",{"date":40,"type":20},"2027-12",{"name":42,"class":43},"Kaohsiung Medical University Chung-Ho Memorial Hospital","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100629411","phase-2-disitamab-vedotin-combined-with-sox-regimen-versus-sox-alone-as-adjuvant-therapy-for-her2-moderatehigh-expressing-stage--gastric-cancer-a-prospective-multicenter-randomized-phase--clinical-trial-100629411","NCT07474324","Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate\u002FHigh Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial","Inclusion Criteria:\n\n* Aged between 18 and 75 years.\n* Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status.\n* No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery.\n* Histopathologically confirmed gastric adenocarcinoma.\n* Pathological stage III gastric and gastroesophageal junction adenocarcinoma patients (according to the 8th edition of the American Joint Committee on Cancer \\[AJCC\\] staging system).\n* HER2 moderate-to-high expression (IHC 3+ or 2+).\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n* Expected survival time ≥ 3 months.\n* Able to understand the study protocol, voluntarily participate in the study, and provide written informed consent;\n* Good compliance and able to cooperate with the treatment regimen specified in this study;\n* Possesses complete imaging and pathological clinical data;\n* Adequate organ and bone-marrow function.\n\nExclusion Criteria:\n\n* Primary stage III gastric or gastroesophageal-junction adenocarcinoma not histologically or cytologically confirmed;\n* Unable to receive disitamab vedotin or SOX chemotherapy;\n* Unable to comply with the required follow-up schedule;\n* Unable to accept the treatment regimen specified in this protocol;\n* Unable or unwilling to undergo mandated response assessments (e.g., CT imaging);\n* Active autoimmune disease;\n* History of psychoactive-substance abuse that cannot be discontinued, or any severe\u002Funcontrolled psychiatric disorder, or any severe\u002Funcontrolled systemic disease;\n* Any concomitant condition that, in the investigator's opinion, poses significant risk to the subject or could compromise study completion;\n* Other malignancies within 5 years before screening, except adequately treated cancers considered cured (e.g., thyroid cancer, cervical carcinoma in situ, basal\u002Fsquamous-cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery);\n* Lactating women;\n* Prior neoadjuvant therapy or intra-operative intraperitoneal chemotherapy.","75 Years",{"count":52,"type":20},124,[24],"This is a prospective, multicenter, randomized, phase II clinical trial intended to enroll patients with HER2-moderate\u002Fhigh-expressing, pathologically staged stage III gastric cancer who have undergone D2 or more extensive surgery. The study aims to evaluate the preliminary efficacy and safety of disitamab vedotin combined with the SOX regimen versus SOX alone as post-operative adjuvant therapy.",[27],[57,58,59,60],"adjuvant therapy","Gastric Adenocarcinom","RC48","SOX","RECRUITING","2026-03-11",{"date":64,"type":36},"2026-03-16",{"date":66,"type":20},"2026-03-15",{"date":68,"type":20},"2030-12-31",{"name":70,"class":43},"The First Affiliated Hospital with Nanjing Medical University",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":71},"100568663","phase-2-mecapegfilgrastim-combined-with-adebrelimab-and-chemotherapy-as-neoadjuvant-therapy-in-resectable-gcgejc-100568663","NCT06684158","Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC\u002FGEJC","Mecapegfilgrastim Combined With Adebrelimab and Chemotherapy as Neoadjuvant Therapy in Resectable GC\u002FGEJC: A Prospective, Randomized, Multicenter, Phase 2 Study.","Inclusion Criteria:\n\n* 1.Subjects aged 18-75 years (including 18 and 75 years old);\n* 2.Subjects who understand the study procedures and content, and voluntarily sign the written informed consent form;\n* 3.Subjects with HER2-negative or HER2 status unknown gastric or gastroesophageal junction adenocarcinoma, clinically staged as T3-4a\u002FN+M0 locally advanced gastric cancer by ultrasound gastroscopy, CT\u002FMRI and other imaging evaluations.\n* 4.Subjects who have not received prior systemic therapy.\n* 5.Subjects with Eastern Cooperative Oncology Group Performance Status score (ECOG PS score): 0-1;\n* 6.Subjects with life expectancy ≥ 12 months;\n* 7.Subjects with good major organ function, that is, the relevant investigation indicators within 14 days before enrollment meet the following requirements: haemoglobin ≥ 90 g\u002FL ; neutrophil count \\> 1.5 × 109\u002FL; platelet count ≥ 100 × 109\u002FL; total bilirubin ≤ 1.5 × ULN (upper limit of normal); alanine transaminase (ALT) or aspartate transaminases (AST) ≤ 2.5 × ULN; endogenous creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula); cardiac ultrasound doppler assessment: left ventricular ejection fraction (LVEF) ≥ 50%;\n* 8.Subjects with thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3\u002FFT4) within the normal range or with slight and clinically insignificant abnormalities;\n* 9.Subjects weighing more than 40 kg, or with BMI \\> 18.5;\n\nExclusion Criteria:\n\n* 1.Subjects with a history of or concurrent with other tumors malignant, except for cured early-stage tumors, including basal cell carcinoma of the skin and carcinoma in situ of the cervix, and early-stage tumors such as stage I lung cancer and stage I rectal cancer that have received radical treatment and are judged by the investigator not to affect the subject's life in the short term.\n* 2.Subjects who have participated in other drug clinical studies within 4 weeks;\n* 3.Subjects with a history of haemorrhage, the severity of any grade ≥ 3 haemorrhage event according to CTCAE 5.0 criteria within 4 weeks prior to screening;\n* 4.Prior to screening, there were known highly suspected distant metastases, such as suspected peritoneal nodules, suspected cancerous ascites, and no laparoscopic confirmation;\n* 5.Subjects with hypertension that cannot be well controlled with single-drug therapy (blood pressure systolic \\> 140 mmHg, blood pressure diastolic \\> 90 mmHg); subjects with a history of unstable angina pectoris; subjects newly diagnosed with angina pectoris within 3 months before screening or with myocardial infarction within 6 months before screening; arrhythmia (including QTcF: male ≥ 450 ms, female ≥ 470 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association class ≥ II cardiac insufficiency;\n* 6.Subjects with long-term unhealed wounds or incompletely healed fractures;\n* 7.Subjects whose imaging shows that the tumor has invaded the periphery of major blood vessels, or the investigator judges that the subject's tumor has a very high possibility of invading major blood vessels during treatment, causing fatal haemorrhage;\n* 8.Subjects with abnormal coagulation function and haemorrhagic diathesis (must meet the following criteria within 14 days before enrollment: INR within the normal range without the use of anticoagulants); subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) is allowed for prophylactic purposes, provided that the international normalized ratio (INR) of prothrombin time is ≤ 1.5;\n* 9.Subjects with a history of arterial\u002Fvenous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischaemic attack), deep vein thrombosis (excluding venous thrombosis caused by previous chemotherapy catheterization that has been judged to be cured by the investigator) and pulmonary embolism, etc.;\n* 10.Subjects whose urinalysis test showing protein urine ≥ ++ and confirmed 24-hour protein urine quantification \\> 1.0 g;\n* 11.Subjects with a history of immune targeted therapy;\n* 12.Subjects with a history of immunodeficiency, or suffering from other acquired or immunodeficiency congenital diseases, or history of organ transplant;\n* 13.Subjects with pneumonia, non-infectious pneumonia, interstitial pneumonia and other subjects who need to use corticosteroids;\n* 14.Subjects with a history of severe chronic autoimmune diseases, such as systemic lupus erythematosus; a history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease; a history of chronic diarrheal diseases such as irritable bowel syndrome; a history of nodular disease or tuberculosis; active hepatitis B, hepatitis C, and HIV infection; well-controlled non-serious immune diseases such as dermatitis, arthritis, and psoriasis can be enrolled. Subjects with a hepatitis B virus titer \\\u003C 2000 copy\u002FmL can be enrolled.\n* 15.Subjects with hypersensitivity to humanized or murine monoclonal antibodies;\n* 16.Subjects with a history of mental drug abuse who are unable to abstain or who have a mental disorder;\n* 17.Subjects who do not follow doctor's advice, do not take medicine as prescribed, or have incomplete data, which may affect the judgment of efficacy or safety;\n* 18.Subjects with serious concomitant diseases that, in the judgment of the investigator, endanger the subject's safety or affect the subject's completion of the study;",{"count":80,"type":20},70,[24],"This study is a prospective, randomized ，multicencter, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The purpose of this study is to assess the safety and efficacy of Mecapegfilgrastim Combined With Adebrelimab and 5- fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT)） as Neoadjuvant Therapy in Resectable gastric and gastroesophageal junction cancer",[27],"2024-11-10",{"date":86,"type":36},"2024-11-12",{"date":88,"type":20},"2024-11-30",{"date":90,"type":20},"2027-12-01",{"name":70,"class":43},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":71},"100554992","phase-2-a-phase-ii-trial-of-perioperative-adebrelimab-combined-with-xelox-in-resectable-locally-advanced-gastricgastroesophageal-junction-cancer-gcgejc-100554992","NCT06506292","A Phase II Trial of Perioperative Adebrelimab Combined With XELOX in Resectable Locally Advanced Gastric\u002FGastroesophageal Junction Cancer (GC\u002FGEJC)","Inclusion Criteria:\n\n1. Patients voluntarily enrolled in the study and signed an informed consent form\n2. 18-75 years old, male and female gender are not limited\n3. Gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction as determined by pathologic histology\n4. Clinical staging of II-III\u002FT3-4aNxM0 (AJCC 8th edition cTNM staging of gastric cancer)\n5. Clinically judged to be surgically resectable\n6. have at least one measurable lesion (according to the requirements of RECISTv1.1, the long diameter of spiral CT scan of this measurable lesion is ≥10mm or the short diameter of enlarged lymph node is ≥15mm)\n7. No other anti-tumor therapy has been received\n8. ECOG score:0\\~1\n9. Good function of major organs\n10. No active hepatitis B virus (HBV) infection\n11. Women of childbearing potential must have had a negative blood pregnancy test within 3 days prior to randomization and be willing to use an appropriate method of contraception during the trial and for 6 months after completion of treatment. For men, surgical sterilization or agreement to use an appropriate method of contraception during the study and for 3 months after completion of treatment.\n\nExclusion Criteria:\n\n1. patients who are pregnant or breastfeeding\n2. Received prior anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy\n3. other malignant tumor (except basal or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer) within the past 5 years\n4. Uncontrolled pleural effusion, pericardial effusion or ascites\n5. Clinically determined to be inoperable or with distal metastasis\n6. Severe cardiovascular disease, such as symptomatic coronary artery disease, class ≥II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, within 12 months prior to enrollment.\n7. Complicated upper gastrointestinal tract obstruction\u002Fbleeding or digestive dysfunction or malabsorption syndrome\n8. History of gastrointestinal perforation in the 6 months prior to enrollment\n9. Severe uncontrolled co-infection or other severe uncontrolled concomitant disease, moderate or severe renal impairment\n10. Have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Grade II or higher cardiac insufficiency according to the New York Heart Association (NYHA) criteria (see Appendix 5) or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) \\< 50%; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year prior to the initiation of study treatment; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc\\>450ms (men); QTc\\>470ms (women) (QTc interval calculated by the Fridericia formula; in case of QTc abnormality, three consecutive measurements can be taken at 2-minute intervals and averaged)\n11. have an allergic reaction to the drugs used in the study\n12. Use of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding topical glucocorticosteroids by nasal, inhalational, or other routes or physiologic doses of systemic glucocorticosteroids (i.e., no more than 10 mg\u002Fday of prednisone or equivalent doses of other glucocorticosteroids), or use of hormones for the prevention of contrast allergy\n13. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n14. current concomitant interstitial pneumonitis or interstitial lung disease, or a prior history of interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or other conditions that may interfere with the determination and management of immune-related pulmonary toxicity such as pulmonary fibrosis, mechanized pneumonitis (e.g., occlusive bronchiectasis), pneumonias, drug-associated pneumonias, idiopathic pneumonias, or active pneumonitis as seen on screening chest computed tomography (CT) maps Evidence of or severely impaired lung function in subjects with a history of radiation pneumonitis in the permitted radiation field, active tuberculosis\n15. presence of active autoimmune disease or history of autoimmune disease with potential for relapse (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, and hypothyroidism \\[subjects who can be controlled by hormone replacement therapy only are eligible for enrollment\\]); subjects with a dermatological condition that does not require systemic treatment such as vitiligo psoriasis, alopecia areata, controlled type I diabetes mellitus treated with insulin or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; asthmatics requiring medical intervention with bronchodilators may not be included\n16. Immunosuppressive or systemic hormone therapy for immunosuppression within 14 days prior to initiation of study treatment (doses \\>10 mg\u002Fday of prednisone or other equipotent hormone)\n17. severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia; therapeutic antibiotics given orally or intravenously within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infection or exacerbation of COPD are eligible for study participation))\n18. Patients with congenital or acquired immune deficiency (e.g., HIV-infected)\n19. Use of immunosuppressive medications within 4 weeks prior to the first dose of study drug\n20. live attenuated vaccine within 4 weeks prior to the first dose or plan to receive live attenuated vaccine during the study period\n21. previous treatment with other anti-PD-1 antibodies or other immunotherapy against PD-1\u002FPD-L1;\n22. permitted palliative radiotherapy to non-target lesions for symptom control, which must have been completed at least 2 weeks prior to initiation of study treatment use, with no recovery from radiotherapy-induced adverse events to ≤ CTCAE grade 1\n23. received other experimental drug therapy within 28 days prior to initiation of study treatment\n24. In the judgment of the investigator, the patient has other factors that may affect the results of the study or cause this study to be forced to be terminated in midstream, such as alcoholism, drug abuse, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the patient\\'s safety.",{"count":99,"type":20},25,[24],"To observe and evaluate the efficacy and safety of adebrelimab combination chemotherapy regimen in the perioperative treatment of surgically resectable gastric cancer\u002Fadenocarcinoma of the gastroesophageal junction.",[103,104,27],"Adebrelimab (SHR-1316)","XELOX","2024-07-11",{"date":107,"type":36},"2024-07-17",{"date":109,"type":36},"2024-07-01",{"date":111,"type":20},"2027-08-01",{"name":113,"class":43},"Tianjin Medical University Cancer Institute and Hospital"]