[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-or-esophagogastric-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-or-esophagogastric-junction-adenocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100636698","phase-2-neoadjuvant-tislelizumab--lm-302--s-1-or-tislelizumab--sox-for-cldn182-positive-gastricgej-adenocarcinoma-100636698",false,"NCT07569068","Neoadjuvant Tislelizumab + LM-302 + S-1 or Tislelizumab + SOX for CLDN18.2-Positive Gastric\u002FGEJ Adenocarcinoma","Tislelizumab Combined With LM-302 and S-1 Versus Tislelizumab Combined With SOX for Neoadjuvant Treatment of Claudin 18.2-positive Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Prospective, Randomized, Exploratory Study","Inclusion Criteria:\n\n* Patients voluntarily participate in this study and sign the informed consent form;\n* Age ≥ 18 years;\n* Histopathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;\n* HER2 negative;\n* Determined by contrast-enhanced CT and laparoscopy to have radically resectable disease with clinical stage T3-4 N+ M0 (according to the AJCC 8th edition);\n* Claudin 18.2 positive (≥25% of tumor cells showing moderate-to-strong membrane staining);\n* No prior receipt of other targeted therapies against claudin 18.2;\n* ECOG performance status 0-1;\n* Life expectancy ≥ 12 months;\n* Adequate major organ function.\n\nExclusion Criteria:\n\n* Known HER2-positive gastric cancer；\n* Gastroesophageal junction (EGJ) cancer involving the proximal stomach with the tumor center located ≤2 cm from the EGJ；\n* Peritoneal metastasis, positive peritoneal cytology (CY1P0), or retroperitoneal lymph node metastasis (No. 16a2\u002Fb1) or other distant metastases;\n* Presence of unresectable factors, including unresectability due to tumor characteristics, surgical contraindications, or patient refusal of surgery;\n* Prior or concurrent other malignancy, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast;\n* Presence of any of the following cardiac clinical symptoms or diseases:\n\n  * New York Heart Association (NYHA) class ≥2 heart failure or left ventricular ejection fraction (LVEF) \\\u003C50% on color Doppler echocardiography;\n  * Unstable angina;\n  * Resting electrocardiogram (ECG) showing QTc \\>450 ms (male) or QTc \\>470 ms (female);\n  * Resting ECG showing clinically significant abnormalities (e.g., abnormalities in heart rate, conduction, morphology), complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, or PR interval \\>250 ms.\n* History of gastrointestinal perforation, intra-abdominal abscess, or intestinal obstruction within the past 3 months, or evidence of intestinal obstruction by imaging or clinical symptoms;\n* Arterial\u002Fvenous thrombotic events within 6 months before randomization, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism;\n* Known hereditary or acquired bleeding or thrombotic predisposition (e.g., hemophilia, coagulation disorders, thrombocytopenia);\n* Active peptic ulcer, unhealed wound, or bone fracture;\n* Active infection requiring antimicrobial therapy (e.g., antibacterial, antiviral, or antifungal treatment);\n* Active hepatitis \\[hepatitis B: HBsAg positive and HBV DNA ≥500 IU\u002FmL; hepatitis C: HCV antibody positive and HCV viral load \\> upper limit of normal\\]; 13. Congenital or acquired immunodeficiency (e.g., HIV-infected patients);\n* Planned or prior organ or allogeneic bone marrow transplantation;\n* Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia\u002F lung disease requiring steroid therapy, or other pulmonary conditions that may interfere with the assessment and management of immune-related lung toxicity, including pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonia or severe pulmonary dysfunction on screening CT scan;\n* Active pulmonary tuberculosis;\n* Any active autoimmune disease or history of autoimmune disease with potential for relapse \\[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controlled with hormone replacement therapy alone are eligible)\\];\n* Known hypersensitivity to any study drug or excipient;\n* Lactating women;\n* Any other condition that, in the investigator's judgment, may affect the study results or necessitate premature termination of the study, such as alcohol or drug abuse, other serious diseases (including psychiatric disorders) requiring concomitant treatment, significant laboratory abnormalities, or family\u002Fsocial factors that could compromise patient safety.","ALL","18 Years",{"count":19,"type":20},88,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","In this study, the investigators will use Tislelizumab combined with LM-302 and S-1 versus Tislelizumab combined with SOX to treat Claudin 18.2-positive locally advanced gastric or gastroesophageal junction adenocarcinoma.",[26],"Gastric or Esophagogastric Junction Adenocarcinoma",[26,28,29,30,31],"Claudin 18.2","LM-302","Tislelizumab","SOX","RECRUITING","2026-05-01",{"date":35,"type":36},"2026-05-06","ACTUAL",{"date":38,"type":20},"2026-04-21",{"date":40,"type":20},"2029-04-30",{"name":42,"class":43},"Ruijin Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":70,"locationsCount":44},"100635742","phase-2-lm-302-and-s-1-plus-intraperitoneal-paclitaxel-with-or-without-cadonilimab-for-claudin-182-positive-gastric-or-gastroesophageal-junction-adenocarcinoma-with-peritoneal-metastasis-a-prospective-exploratory-study-100635742","NCT07556640","LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: a Prospective, Exploratory Study","LM-302 and S-1 Plus Intraperitoneal Paclitaxel With or Without Cadonilimab for Claudin 18.2-positive Gastric Cancer With Peritoneal Metastasis: a Prospective, Exploratory Study","Inclusion Criteria:\n\n* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma with her 2 (-), and without the history of resection of primary or metastatic lesion;\n* Age ≥ 18 years at registration;\n* Peritoneal metastases from gastric cancer requiring definitive diagnosisby laparoscopy, and without gastric outflow tract obstruction andintestinal obstruction;\n* Claudin 18.2 positive (≥ 25%, moderate to strong staining);\n* Eastern Cooperative Oncology Group (ECOG) score ≤ 1;\n* Expected life expectancy \\> 3 months;\n* Adequate bone marrow, liver, and renal functions.\n\nExclusion Criteria:\n\n* Presence of distant metastases other than peritoneal metastasis at the time of enrollment;\n* Pregnant or breastfeeding women;\n* Prior treatment with Claudin 18.2 targeted therapy;\n* History of other malignancies within the past 5 years, except for cured skin cancer or cervical carcinoma in situ;\n* History of uncontrolled epilepsy, central nervous system disease, or mental disorder that, in the investigator's judgment, may interfere with signing informed consent or compliance with oral medication.\n* Clinically significant active heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or higher congestive heart failure, severe arrhythmia requiring medication, or myocardial infarction within the past 12 months;\n* Upper gastrointestinal obstruction, abnormal physiological function, or malabsorption syndrome that may affect S 1 absorption;\n* Known peripheral neuropathy ≥ NCI CTC AE grade 1. However, patients with loss of deep tendon reflexes (DTR) alone may be included;\n* Organ transplantation requiring immunosuppressive therapy;\n* Severe uncontrolled recurrent infection or other severe uncontrolled concomitant diseases;\n* Moderate or severe renal impairment (creatinine clearance ≤ 50 ml\u002Fmin) or serum creatinine above the upper limit of normal;\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency;\n* Active hepatitis (for hepatitis B: HBsAg positive and HBV DNA ≥ 500 IU\u002Fml; for hepatitis C: HCV antibody positive and HCV viral load \\> upper limit of normal);\n* Psychiatric disorder that makes the patient unable to comply with treatment;\n* Allergy to paclitaxel or any component of the study drugs;\n* History or evidence of any disease, condition, treatment, or laboratory abnormality that could interfere with the study results or the patient's full participation, or any other condition that, in the investigator's opinion, makes the patient unsuitable for enrollment.",{"count":53,"type":20},74,[23],"In this study, the investigators will use LM-302 and S-1 plus intraperitoneal paclitaxel with or without Cadonilimab to treat Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis.",[57,58,26],"Gastric Cancer Stage IV","Peritoneal Metastases From Gastric Cancer",[60,61,28,62,63,26],"Gastric cancer","Peritoneal metastasis","Cadonilimab","Paclitaxel","2026-04-24",{"date":66,"type":36},"2026-04-29",{"date":68,"type":36},"2026-04-17",{"date":40,"type":20},{"name":42,"class":43},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100514404","phase-3-nimotuzumab-combined-with-paclitaxel-for-recurrent-metastatic-gastric-or-esophagogastric-junction-adenocarcinoma-100514404","NCT05978050","Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma","Nimotuzumab Combined With Paclitaxel as Second-line Treatment for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma With EGFR Over-expression: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial","NOTABLE-307","Inclusion Criteria:\n\n* 1\\. Age: 18-75 years old (including boundary value), male or female;\n* 2\\. The physical status score ECOG is 0-1;\n* 3\\. Histopathologically or cytologically confirmed gastric or esophagogastric junction adenocarcinoma;\n* 4\\. Recurrent metastatic disease, previous treatment with first-line standard chemotherapy regimens (including platinum-containing and\u002For fluorouracil regimens) (recurrence or metastasis during adjuvant therapy or within 6 months after completion is considered first-line therapy), or received anti-HER2 therapy, or received immunotherapy, and has been confirmed by the investigator or has a clear disease progression in the medical history;\n* 5\\. At least one evaluable tumor lesion according to the RECIST version 1.1 evaluation criteria;\n* 6\\. Detection of primary or metastatic lesions during the screening period (when multiple specimens exist at the same time, the bulk specimen is preferred over the biopsy specimen, and the metastasis is preferred over the primary lesion) tissue is determined to be EGFR high expression (IHC2+ or IHC3+);\n* 7\\. Estimated survival≥ 12 weeks;\n* 8\\. Have proper organ function, defined as:Total bilirubin ≤ 1.5 times the upper normal limit (ULN); glutamyltransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times ULN in the absence of liver metastases; ALT or AST ≤ 5 times ULN in the presence of liver metastases;Serum creatinine level≤ 1.5 times ULN; neutrophil count ≥1.5×109\u002FL; WBC count≥ 3.0×109\u002FL; platelets≥ 100×109\u002FL; Hemoglobin≥ 90g\u002FL;\n* 9\\. Patients of childbearing age and their spouses are willing to use contraception;\n* 10\\. Women of potential fertility have negative serum hCG within 72 hours prior to randomization (postmenopausal women with amenorrhea for at least 12 months are considered infertile, and women who are known to have undergone tubal ligation are not required to undergo a pregnancy test);\n* 11\\. The subject understands and complies with the study process, voluntarily participates, and signs the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Received the following treatments before this study:\n\n  1. The disease has progressed after previous paclitaxel chemotherapy or molecular targeted drug (anti-EGFR antibody) treatment, or received paclitaxel chemotherapy or molecular targeted drug (anti-EGFR antibody) treatment within 4 weeks before randomization;\n  2. Within 4 weeks before randomization or participating in other therapeutic\u002Fintervention clinical trials or receiving combined treatment prohibited by the protocol;\n* 2\\. Received major surgical treatment, incision biopsy (such as laparotomy) or obvious traumatic injury within 4 weeks before randomization;\n* 3\\. Brain metastases or meningeal metastases;\n* 4\\. Has a history of malignant tumors other than gastric adenocarcinoma or esophagogastric junction adenocarcinoma (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for 5 years);\n* 5\\. Known to have suffered from severe bleeding disorders (such as severe gastrointestinal bleeding) and vasculitis within 3 months before randomization;\n* 6\\. Known to be accompanied by other serious diseases, including but not limited to:\n\n  1. Refractory congestive heart failure (NYHA classification III or IV, see Appendix 2), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or high blood pressure (SBP\\>160mmHg or DBP\\>100mmHg );\n  2. Uncontrolled diabetes;\n  3. Mental illness that affects informed consent and\u002For protocol compliance;\n  4. There are serious diseases that other researchers believe are not suitable for participating in this study;\n* 7\\. Known allergies or contraindications to anti-EGFR antibody preparations, paclitaxel and other components;\n* 8\\. Patients who have previously used immune checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), such as the following adverse events related to immune checkpoint inhibitors and have not recovered to grade 1 And below, not suitable for inclusion: Grade ≥3 ocular adverse events, abnormal liver function in line with Hy's Law standard adverse events, ≥3 neurological toxicity, ≥3 grade colitis, ≥3 grade renal toxicity;\n* 9\\. Those who are known to have third space effusion (including a large amount of pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n* 10\\. Known NCI CTC grade 2-4 peripheral neuropathy;\n* 11\\. Known history of primary or secondary immunodeficiency or current active primary or secondary immunodeficiency;\n* 12\\. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA ≥ 1000 IU\u002Fml or hepatitis C virus (HCV) RNA positive (inactive hepatitis B surface antigen carriers, treated And stable hepatitis B patients \\[HBV DNA \\\u003C1000 IU\u002Fml and cured hepatitis C patients can be selected\\]); Treponema pallidum antibody positive or human immunodeficiency virus antibody positive or any uncontrolled infection By;\n* 13\\. Women of childbearing age who are pregnant, breast-feeding, planning to become pregnant, or who have not taken reliable birth control measures and men in the sexually active period who are unwilling to take birth control measures during the study period and within 3 months after the last medication, and during the above-mentioned specified time Sperm donors;\n* 14\\. Any medical, psychiatric or other condition or situation that the investigator believes that the subject's participation in this clinical research may have a negative impact on the safety of the subject or the reliability of the research data.","75 Years",{"count":81,"type":20},354,[83],"PHASE3","In order to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel as second-line treatment for recurrent metastatic gastric or esophagogastric junction adenocarcinoma with EGFR over-expression, investigators performed a randomized, double-blind, placebo-controlled phase III clinical trial. Patients will be randomized (1:1) to receive nimotuzumab plus paclitaxel in the experimental group and placebo plus paclitaxel in the control group. The primary endpoint of this study was OS, and according to the results of the RAINBOW-Asia gastric cancer phase III clinical study, the mOS of paclitaxel single-agent second-line treatment for gastric cancer was 7.92 months, assuming that the mOS increased to 10.92 months after the addition of nimotuzumab, Using the survival module in the PASS15 software, the two-sided test level was set α=0.05, β=0.20, enrolled for 2 years, followed up for 1.5 years, the dropout rate was 5%, the sample size including interim analysis was 354 cases. The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), patient reported outcome (PRO), and safety.",[26],"2024-08-27",{"date":88,"type":36},"2024-08-28",{"date":90,"type":36},"2024-08-01",{"date":92,"type":20},"2026-03-01",{"name":94,"class":43},"Biotech Pharmaceutical Co., Ltd."]