[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric--gastroesophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric--gastroesophageal-junction-adenocarcinoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,41,82,105,129,150,174,198,220,240,257,278,304],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100641077","mmr-status-modulates-the-predictive-value-of-lymphatic-invasion-for-lymph-node-metastasis-in-gastric-cancer-100641077",false,"NCT07625735","MMR Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer","Mismatch Repair (MMR) Status Modulates the Predictive Value of Lymphatic Invasion for Lymph Node Metastasis in Gastric Cancer","Inclusion Criteria:\n\n1. Upfront surgery cohort\n\n   * Patients who underwent radical surgery for gastric cancer at Zhongshan Hospital, Fudan University.\n   * Patients who did not receive neoadjuvant chemotherapy, radiotherapy, immunotherapy, or other antitumor treatments that may affect the pathological assessment of the primary tumor or lymph node metastasis before surgery.\n   * Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after surgery, including Siewert type II and III tumors only.\n   * Patients with definite pathological assessment of lymphatic invasion and regional lymph node status.\n   * Patients with available and definite MMR status.\n2. ESD cohort\n\n   * Patients who underwent ESD for gastric cancer at Zhongshan Hospital, Fudan University.\n   * Patients with pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma after ESD, including Siewert type II and III tumors only.\n   * Patients with complete post-ESD pathological information, including histological type, depth of invasion, tumor size, ulcerative findings, lymphatic invasion status, venous invasion status, horizontal margin status, and vertical margin status.\n   * Patients with available and definite MMR status.\n\nExclusion Criteria:\n\n1. Upfront surgery cohort\n\n   * Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.\n   * Patients who received neoadjuvant treatment before surgery, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or other systemic antitumor treatments.\n   * Patients with missing postoperative pathological information, resulting in inability to determine lymphatic invasion or regional lymph node metastasis status.\n   * Patients with missing or indeterminate MMR status.\n   * Patients with concurrent malignancies that may interfere with the determination of the origin of lymph node metastasis.\n2. ESD cohort\n\n   * Patients with other pathological types, such as gastric squamous cell carcinoma or neuroendocrine carcinoma.\n   * Patients with missing post-ESD pathological information that precludes eCURA classification, eCURA risk score calculation, or assessment of lymphatic invasion status.\n   * Patients with missing or indeterminate MMR status.","ALL","18 Years","95 Years",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","Brief Summary\n\nLymph node metastasis (LNM) is a key factor influencing treatment decisions and prognosis in patients with gastric cancer. Lymphatic invasion (LI) is an important pathological predictor of LNM and a core component of the eCURA risk scoring system after endoscopic submucosal dissection (ESD) for early gastric cancer. However, whether LI has the same predictive value for LNM across different mismatch repair (MMR) statuses remains unclear. Compared with proficient mismatch repair (pMMR) gastric cancer, deficient mismatch repair (dMMR) gastric cancer has distinct molecular pathological features and an immune-enriched tumor microenvironment. In early gastric cancer, if LI is associated with a lower LNM risk in dMMR tumors than in pMMR tumors, existing LI-based eCURA risk assessment may overestimate LNM risk in patients with dMMR early gastric cancer and consequently affect decisions regarding additional surgery after ESD. Therefore, this study aims to systematically evaluate the impact of MMR status on the association between LI and LNM using upfront-surgery and post-ESD additional-surgery cohorts from our center, and to explore the potential clinical value of MMR status in refining eCURA-based risk stratification for early gastric cancer.",[25,26,27,28],"Gastric \u002F Gastroesophageal Junction Adenocarcinoma","Mismatch Repair Deficient or MSI-High Solid Tumors","Lymph Node Metastasis","Lymphatic Invasion","NOT_YET_RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-18","ACTUAL",{"date":35,"type":21},"2026-07-01",{"date":37,"type":21},"2027-07-31",{"name":39,"class":40},"Shanghai Zhongshan Hospital","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100576736","phase-1-a-phase-1-first-in-human-study-of-okn4395-and-pembrolizumab-in-patients-with-solid-tumors-100576736","NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate",{"count":50,"type":21},146,"INTERVENTIONAL",[53],"PHASE1","The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[56,57,58,59,60,61,62,63,64,65,66,67,68,69,25],"Solid Tumours","Sarcoma","HNSCC","Non Small Cell Lung Cancer","NSCLC","Colorectal Cancer (CRC)","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma","Leiomyosarcoma (LMS)","Gastric Cancer (GC)","Gastric Cancer Adenocarcinoma Metastatic","RECRUITING","2026-06-09",{"date":73,"type":33},"2026-06-11",{"date":75,"type":33},"2025-01-23",{"date":77,"type":21},"2028-09",{"name":79,"class":80},"Epkin","INDUSTRY",10,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":51,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100632074","phase-3-feasibility-of-circulating-tumor-dna-based-minimal-residual-disease-guided-adjuvant-therapy-in-locally-advanced-gastric-cancer-with-neoadjuvant-treatment-100632074","NCT07508956","Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment","Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment: An Open-Label, Randomized, Multi-Centered Phase III Trial","MRD-ATLAS-III","Inclusion Criteria:\n\n1. Able to provide written informed consent (ICF) and capable of understanding and agreeing to comply with the study requirements and assessment schedule;\n2. Male or female aged ≥ 18 years;\n3. Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, with clinical TNM stage (according to the 8th edition of the AJCC\u002FUICC clinical TNM staging system for gastric cancer; see Appendix 1) of cIIB-IVA, and the primary gastric tumor assessed as amenable to radical resection;\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 2), fit to undergo surgical treatment with no contraindications to surgery;\n5. Capable of providing adequate tumor tissue obtained via gastroscopy (or other means) prior to neoadjuvant treatment for whole-exome sequencing;\n6. Females of childbearing potential must have a negative pregnancy test within 7 days before initiation of neoadjuvant treatment. Males and females of childbearing potential must agree to use adequate contraception during the study period and for 24 months after the last dose of study treatment (see Appendix 3);\n7. Hematologic and biochemical parameters meeting the following criteria prior to neoadjuvant treatment:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n   * Platelet count (PLT) ≥ 75 × 10⁹\u002FL\n   * Hemoglobin (Hb) ≥ 80 g\u002FL\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN)\n   * Serum creatinine (Cr) ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m²\n   * Serum albumin (ALB) ≥ 30 g\u002FL\n   * For subjects not receiving anticoagulant therapy: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; for subjects receiving anticoagulant therapy: PT within the expected therapeutic range for the anticoagulant;\n8. No prior anticancer therapy for the current study-related tumor prior to initiation of neoadjuvant treatment.\n\nExclusion Criteria:\n\n1. Patients deemed by the investigator to have significant contraindications to or intolerance of neoadjuvant\u002Fadjuvant therapy;\n2. Female patients of childbearing potential who have not undergone surgical sterilization or are not using adequate contraceptive measures, pregnant or lactating women, or male patients planning to father a child within a short period;\n3. Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active hemorrhage, diabetes mellitus, etc.;\n4. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis, human immunodeficiency virus (HIV) infection, etc.;\n5. Prior history of malignancy or current presence of another malignancy, except for completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast with at least 5 years without recurrence;\n6. Other conditions deemed by the investigator to render the patient unsuitable for study participation.",{"count":91,"type":21},304,[93],"PHASE3","For locally advanced gastric adenocarcinoma\u002Fesophagogastric junction adenocarcinoma, the currently recommended treatment strategy per clinical guidelines is radical gastrectomy combined with perioperative therapy (including chemotherapy, immunotherapy, etc.). This approach involves several cycles of neoadjuvant therapy prior to surgery, followed by the surgical procedure, and then several cycles of adjuvant therapy post-surgery. This regimen is generally considered to offer favorable efficacy, ultimately leading to improved survival outcomes for patients. However, some patients are unable to complete the prescribed postoperative adjuvant therapy due to factors such as poor physical condition after surgery or cumulative treatment toxicity. Findings from the retrospective SPACE-FLOT study preliminarily suggest that for patients with a favorable response to neoadjuvant therapy, postoperative adjuvant therapy may not confer additional survival benefit, while potentially increasing the risk of treatment-related adverse events. Therefore, the investigators aim to utilize the latest technological approaches to identify patients who could safely forgo adjuvant therapy, enabling personalized treatment decisions, reducing unnecessary treatment, and thereby maximizing patients' long-term survival benefits.\n\nTo achieve this objective, the investigators have identified circulating tumor DNA (ctDNA) testing as a potential solution. ctDNA refers to DNA fragments released by tumor cells into the extracellular space (e.g., into the bloodstream). By drawing a small amount of peripheral blood and analyzing the ctDNA within, it is possible to detect minimal residual disease (MRD) that is difficult to identify through conventional imaging methods (such as CT or MRI) after treatment. MRD is considered a critical factor that may lead to tumor recurrence. Utilizing ctDNA to detect MRD enables a convenient and accurate assessment of tumor status and treatment efficacy, thereby offering the potential for personalized treatment.\n\nColorectal cancer represents a cancer type where ctDNA testing has been applied early and is relatively mature. In the field of colorectal cancer, the GALAXY study confirmed that ctDNA positivity can effectively predict patient survival outcomes, with superior performance to other traditional indicators. The study also found that patients with postoperative ctDNA MRD positivity tended to benefit from postoperative adjuvant chemotherapy, whereas those with ctDNA MRD negativity often did not derive such benefit. Subsequently, another randomized controlled trial (the DYNAMIC study) revealed that using ctDNA MRD to guide postoperative adjuvant chemotherapy strategies could effectively reduce unnecessary chemotherapy without adversely impacting patient survival outcomes.\n\nIn the field of gastric cancer, studies such as MENCA-GC, CRITICS, and PLAGAST have all demonstrated that postoperative ctDNA can effectively predict patient prognosis in the treatment model of radical gastrectomy combined with perioperative therapy. Additionally, preliminary findings from the ongoing MRD-GATE study indicate that in treatment models without preoperative neoadjuvant therapy (i.e., surgery followed by adjuvant therapy), utilizing ctDNA MRD to guide postoperative adjuvant treatment can also reduce unnecessary chemotherapy without compromising patient survival outcomes.\n\nThis study focuses on patients with locally advanced gastric cancer, integrating the latest clinical research advancements, and aims to fill the research gap concerning the efficacy of using ctDNA MRD to guide adjuvant therapy within the context of radical gastrectomy combined with perioperative therapy. This holds significant importance for optimizing treatment strategies and maximizing patient benefits.",[25],"2026-06-04",{"date":98,"type":33},"2026-06-08",{"date":100,"type":21},"2026-06-01",{"date":102,"type":21},"2032-03-31",{"name":39,"class":40},1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":104},"100634374","safety-and-efficacy-of-ct0494bcp-in-participants-with-advanced-gastricesophagogastric-junction-adenocarcinoma-100634374","NCT07538856","Safety and Efficacy of CT0494BCP in Participants With Advanced Gastric\u002FEsophagogastric Junction Adenocarcinoma","A Clinical Trial Exploring the Safety and Efficacy of CT0494BCP CAR-T Cell Injection in Participants With Advanced Gastric\u002FEsophagogastric Junction Adenocarcinoma","Inclusion Criteria:\n\nVolunteer to participate in the clinical trial; I fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures; Age 18-70 years (inclusive), male or female; Participants with pathologically confirmed advanced gastric\u002Fesophagogastric junction adenocarcinoma; Failed at least second-line treatment (if the first-line treatment includes three drugs including taxanes \\[or anthracyclines\\], platinum and fluoropyrimidines, the participants can also be enrolled into the trial as eligible as assessed by the investigator); Participant's tumor tissue sample is CLDN18.2 positive by immunohistochemistry (IHC) staining (expression intensity ≥ 2 + and% positive tumor cells ≥ 40%); Estimated survival \\> 12 weeks; Measurable tumor lesions according to RECIST v1.1; ECOG performance status 0 \\~ 1;\n\nUnless otherwise specified, participants should meet the following criteria before clearing the lymphoma (local laboratory results that do not meet the following criteria are allowed to perform a re-examination within one week; if they still do not meet the criteria, they cannot clear the lymphoma):\n\nBlood routine: neutrophil (NE) ≥ 1.5 × 109\u002FL, lymphocyte (LY) 0.5 × 109\u002FL, platelet (PLT) ≥ 75 × 109\u002FL, hemoglobin (Hb) ≥ 9.0 g\u002FdL (no transfusion, platelet transfusion, cell growth factor \\[except recombinant erythropoietin\\] and other supportive treatment within 14 days before detection); Blood biochemistry: endogenous creatinine clearance ≥ 50 mL\u002Fmin (using Cockcroft-Gault formula), alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN; Serum lipase and amylase ≤ 2 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; AST, ALT and alkaline phosphatase ≤ 5 × ULN if there is bone metastasis or liver metastasis; Prothrombin time (PT) prolongation ≤ 4 s. 10. Female participants of childbearing potential must have a negative serum pregnancy test at screening and be willing to use a highly effective and reliable method of contraception for 1 year after the last dose of study treatment. The available methods are: bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusion; Or approved oral, injected or implanted hormonal methods of birth control; Or barrier contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository; Male participants who are sexually active with a female of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control, such as a condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, or to use a contraceptive method for their partner (see Inclusion Criterion # 10). All men absolutely refrain from donating sperm for 1 year after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females;\n2. HIV, Treponema pallidum, HCV serology positive (HCV antibody positive but HCV-RNA negative can be included), Epstein-Barr virus (EBV) DNA (plasma or whole blood) positive, cytomegalovirus (CMV) DNA positive;\n3. Any uncontrolled active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA above the lower limit of the laboratory test in our center), and other bacterial, viral or fungal infections requiring drug treatment. Participants who use drugs to prevent infection and can continue the trial as judged by the investigator;\n4. Known HER2-positive (defined as IHC3 +, or IHC2 + with amplification by FISH);\n5. Clinically significant abnormal thyroid function as judged by the investigator (serum thyroid hormone determination includes at least FT3, FT4 and serum thyroid stimulating hormone TSH), but patients with hypothyroidism whose disease is under stable control as assessed by the investigator can enter the trial;\n6. Toxic reactions caused by previous treatment have not recovered to CTCAE v6.0 ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this trial;\n7. Received anti-tumor treatment for the disease under study within 2 weeks prior to CLL, including but not limited to surgery, systemic chemotherapy (or within 5 half-lives of the drug, whichever is shorter), radiotherapy, intervention, etc., or received anti-PD-(L) 1 monoclonal antibody therapy or CLDN18.2 targeted therapy or other non-marketed clinical trial drugs within 4 weeks prior to CLL (or within 5 half-lives of the drug, whichever is shorter);\n8. Ongoing use of glucocorticoids within 7 days prior to CLL. Recent or current use of inhaled or topical dermal glucocorticoids and physiologic replacement therapy doses of glucocorticoids were not excluded;\n9. Vaccination with live attenuated vaccines within 4 weeks prior to CLL or planned during the trial;\n10. Participants with known active autoimmune disease, including but not limited to psoriasis or rheumatoid arthritis, or other conditions requiring chronic use of immunosuppressive therapy;\n11. Previous allergies to immunotherapy, tocilizumab, cyclophosphamide, fludarabine or nab-paclitaxel and other related drugs, allergies to components of CT0494BCP such as albumin, DMSO or other severe allergies;\n12. Previously received any genetic engineering modified cell therapy (including CAR-T, TCR-T cells, etc.);\n13. Presence of known or suspected central nervous system metastases;\n14. Central type or extensive lung metastasis, or extensive liver metastasis, or extensive bone metastasis;\n15. The longest diameter of a single target lesion \\> 4 cm before CLL (lymph node lesion is short axis);\n16. Participants with high risk of bleeding or perforation, such as deep and large ulcer in primary lesion, or anastomotic recurrence with full-thickness tumor invasion, or tumor lesion invasion into large vessels, as detected by CT\u002FMRI or combined with gastroscopy;\n17. Participants with current unstable or active ulcers, active gastrointestinal bleeding, or a history of major gastrointestinal bleeding within 3 months;\n18. Participants who require anticoagulation therapy such as warfarin or heparin;\n19. Participants who are receiving or anticipate the need to receive long-term antiplatelet therapy during the trial;\n20. Abdominal\u002Fpleural effusion with clinical symptoms or requiring special treatment, such as repeated drainage, abdominal\u002Fpleural drug perfusion, etc. (participants with small amount of ascites\u002Fpleural effusion that can be detected by imaging examination or controllable as assessed by the investigator can be considered for enrollment);\n21. Participants with a history of organ transplantation or who are awaiting organ transplantation;\n22. Participants who have had major surgery or significant trauma within 4 weeks prior to CLL, or anticipate the need for major surgery during the trial;\n23. Other conditions not suitable for participation in this trial as assessed by the investigator prior to CLL, including but not limited to: Poorly controlled diabetes with severe complications, poorly controlled hypertension (blood pressure \\> 160 mmHg\u002F100 mmHg), hypertension requiring vasopressor drugs or symptomatic hypotension, cardiac insufficiency (including left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%), myocardial infarction within the past 6 months, arrhythmia or unstable angina poorly controlled by drug therapy, pulmonary embolism, severe chronic obstructive pulmonary disease, interstitial lung disease, clinically significant abnormal pulmonary function test, gastrointestinal obstruction or perforation within the past 3 months, severe inflammatory state (e.g. Increased neutrophils and\u002For C-reactive protein); Medical discussion with the sponsor is recommended if necessary;\n24. Inability or unwillingness of the participant to comply with the protocol requirements as assessed by the investigator;\n25. Blood oxygen saturation ≤ 95% (finger oxygen detection method is accepted, without oxygen inhalation);\n26. Participant has signs of central nervous system disease or clinically significant abnormal neurological examination results or psychiatric disorders;\n27. Patients with other incurable malignant tumors in the past 3 years or at the same time, except for cervical cancer in situ, skin basal cell carcinoma and other very low-grade tumors.","70 Years",{"count":114,"type":21},50,"To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric\u002Fesophagogastric junction adenocarcinoma (G\u002FGEJA) To evaluate preliminary efficacy of CT0494BCP To evaluate the cellular metabolism kinetics of CT0494BCP The investigational drug in this study is CT0494BCP cells, including CT0494 cells and CT7095 cells. Dose escalation will be performed according to the Bayesian optimal interval (BOIN) design principle (refer to the dose escalation principle in Section 4.1 Study Design Description and the flow chart of BOIN design in Figure 2 for details) and dose expansion. In the dose escalation phase, CT0494 cells were tentatively assigned to 3 escalating doses of 3.0 × 108, 4.5 × 108 and 6.0 × 108, respectively, and CT7095 cells were tentatively assigned to 2 escalating doses of 1.5 × 108 and 3.0 × 108, respectively. If the exploratory dose is not identified as a possible recommended dose (RD), a possible RD may be explored by escalating to a higher dose or tapering to a lower dose at the discretion of the investigator and sponsor in consultation. Dose groups, number of subjects per dose group, and other escalation or de-escalation decisions may be adjusted during the study based on available data.",[117,25],"Gastric",[119],"CT0494BCP","2026-04-13",{"date":122,"type":33},"2026-04-20",{"date":124,"type":21},"2026-04",{"date":126,"type":21},"2028-03",{"name":128,"class":40},"Beijing GoBroad Hospital",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":51,"phases":139,"briefSummary":133,"conditions":140,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100627526","phase-3-a-study-of-ak104-sc-in-combination-with-oxaliplatin-and-capecitabine-xelox-versus-ak104-iv-in-combination-with-xelox-in-participants-with-unresectable-locally-advanced-or-metastatic-gastric-adenocarcinoma-or-gastroesophageal-junction-adenocarcinoma-100627526","NCT07449780","A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","A Randomized, Open-Label, Multicenter, Phase I\u002FIII Clinical Study to Evaluate the Pharmacokinetics, Efficacy and Safety of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Regimen Versus AK104 (IV) in Combination With XELOX Regimen as First-Line Treatment for Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).\n2. Unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction (GEJ).\n3. Participants have not received prior systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.\n4. Adequate organ and bone marrow function.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.\n6. Measurable disease by RECIST 1.1.\n\nExclusion Criteria:\n\n1. Receipt of systemic non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymic peptides, etc.) within 2 weeks prior to the first dose.Receipt of Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose.\n2. Deep venous thrombosis within 3 months before first treatment.\n3. Uncontrolled arterial hypertension.\n4. Bleeding events within the last 1 months.\n5. Prior treatment with immune checkpoint inhibitors.\n6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.","75 Years",{"count":138,"type":21},422,[93],[25],"2026-02-27",{"date":143,"type":33},"2026-03-04",{"date":145,"type":21},"2026-03-31",{"date":147,"type":21},"2028-02-15",{"name":149,"class":80},"Akeso",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":51,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100612891","phase-2-factors-influencing-immunotherapy-response-in-dmmrmsi-h-gastricgastroesophageal-junction-adenocarcinoma-100612891","NCT07259473","Factors Influencing Immunotherapy Response in dMMR\u002FMSI-H Gastric\u002FGastroesophageal Junction Adenocarcinoma","Factors Influencing Immunotherapy Response in Mismatch Repair Deficiency (dMMR) \u002F Microsatellite Instability-High (MSI-H) Gastric\u002FGastroesophageal Junction Adenocarcinoma","Pre-CATALIS","Inclusion Criteria:\n\n* Male or female, aged 18 to 85 years.\n* Histologically confirmed gastric cancer or adenocarcinoma of the esophagogastric junction (only Siewert types II and III are included).\n* dMMR status confirmed by immunohistochemistry (IHC) or MSI-H status confirmed by PCR\u002FNGS.\n* Tumor clinical staging meeting the following criteria:\n\ncT≥2, any N, M0, assessed by the investigator as potentially resectable and planned for preoperative treatment followed by surgery.\n\n* Willing to receive treatment with immune checkpoint inhibitors (including, but not limited to, various PD-1 inhibitors, PD-L1 inhibitors, CTLA-4 inhibitors, PD-1\u002FCTLA-4 bispecific antibodies, etc.), which may be combined with or without standard chemotherapy regimens for gastric cancer.\n\nExclusion Criteria:\n\n* Tumor histology other than adenocarcinoma, such as squamous cell carcinoma, neuroendocrine carcinoma, etc.\n* Presence of central nervous system metastases and\u002For leptomeningeal carcinomatosis.\n* Prior antitumor therapy directed at the current gastric cancer (excluding palliative gastrointestinal bypass surgery performed to relieve obstructive symptoms).","85 Years",{"count":160,"type":21},15,[162],"PHASE2","dMMR\u002FMSI-H is a key molecular subtype of gastric cancer, found in 8-22% of cases. It is typically associated with older age, female sex, distal tumor location, and intestinal histology (Lauren classification). While this subtype predicts better survival in locally advanced disease, its prognostic role in metastatic settings is less clear.\n\nNotably, dMMR\u002FMSI-H tumors are often resistant to conventional chemotherapy. Conversely, they demonstrate exceptional sensitivity to immunotherapy. This has led to effective strategies using immune checkpoint inhibitors, either alone or combined with chemotherapy, in both neoadjuvant and advanced disease settings.\n\nHowever, key challenges remain. Prospective data are largely from Western populations, leaving the efficacy in Asian patients-who bear a high disease burden-less defined. Furthermore, about half of dMMR\u002FMSI-H patients exhibit primary or acquired resistance to immunotherapy. A deeper understanding of the tumor-immune dynamics during treatment is crucial to uncover resistance mechanisms and improve patient outcomes.",[25,26,165],"Immunotherapy","2026-01-02",{"date":168,"type":33},"2026-01-07",{"date":170,"type":21},"2026-01-31",{"date":172,"type":21},"2029-12-30",{"name":39,"class":40},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":51,"phases":184,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":197,"locationsCount":104},"100612730","phase-2-feasibility-of-circulating-tumor-dna-based-minimal-residual-disease-guided-adjuvant-therapy-in-locally-advanced-gastric-cancer-with-neoadjuvant-treatment-an-adaptive-trial-mrd-atlas-100612730","NCT07257380","Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric Cancer With Neoadjuvant Treatment: An Adaptive Trial (MRD-ATLAS)","MRD-ATLAS","Inclusion Criteria:\n\n1. Be able to provide a written informed consent form (ICF), and understand, agree to, and comply with the study requirements and assessment schedule.\n2. Male or female aged 18 to 79 years.\n3. Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ), with clinical TNM staging (per the 8th edition of the AJCC\u002FUICC Clinical TNM Staging for Gastric Cancer) as clinical Stage cIII to cIVa, and the primary gastric cancer lesion assessed to be amenable to curative resection.\n4. ECOG PS ≤ 2, tolerable to surgical treatment, no surgical contraindications.\n5. Females of childbearing potential must have a negative pregnancy test within 7 days prior to initiating neoadjuvant treatment. Males of reproductive potential and females of childbearing potential must agree to use adequate contraceptive measures during the study and for 24 months after the last dose of study medication.\n6. Prior to neoadjuvant treatment, complete blood count (CBC) and biochemical tests must meet the following criteria: a) Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL; b) Platelet Count (PLT) ≥ 75 × 10⁹\u002FL; c) Hemoglobin (Hb) ≥ 80 g\u002FL; d) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × Upper Limit of Normal (ULN); e) Serum Creatinine (Cr) ≤ 1.5 × ULN, or Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m²; f) Serum Albumin (ALB) ≥ 30 g\u002FL; g) For subjects not receiving anticoagulant therapy: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; for subjects receiving anticoagulant therapy: PT value must be within the expected therapeutic range for the anticoagulant used.\n7. No antitumor treatment for the tumor involved in the current study has been administered prior to the initiation of neoadjuvant treatment.\n\nExclusion Criteria:\n\n1. Subjects for whom investigators consider that there are obvious contraindications to (neo)adjuvant treatment or who cannot tolerate (neo)adjuvant treatment.\n2. Females of childbearing potential who have not undergone surgical sterilization or do not use adequate contraceptive measures, pregnant or lactating females, and males who plan to impregnate their partners in the near term.\n3. Any severe or uncontrolled systemic disease, including but not limited to uncontrolled hypertension, active bleeding, diabetes mellitus, and others.\n4. Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral therapy, including but not limited to tuberculosis (TB), human immunodeficiency virus (HIV) infection, and others.\n5. History of previous malignant tumors or other malignant tumors currently present, except for basal cell or squamous cell skin cancer, superficial bladder cancer, prostatic\u002Fcervical\u002Fbreast carcinoma in situ, and other such tumors that have been completely resected with no recurrence for at least 5 years.\n6. Other circumstances that investigators deem inappropriate for study participation.","79 Years",{"count":183,"type":21},90,[162],"Standard treatment for locally advanced gastric cancer currently involves surgery combined with chemotherapy administered both before and after the operation. However, post-surgery (adjuvant) chemotherapy often causes severe side effects, and it is unclear if all patients truly benefit from it. Recent research, such as the SPACE-FLOT study, suggests that patients who respond well to pre-surgery treatment might not actually benefit from further aggressive treatment after surgery; in these cases, additional therapy may only increase the risk of side effects without improving survival.\n\nTo address this, researchers are investigating circulating tumor DNA (ctDNA) testing, which detects microscopic traces of cancer (Molecular Residual Disease, or MRD) in the blood. The utility of ctDNA is supported by extensive research:\n\nIn Colorectal Cancer: The GALAXY study demonstrated that ctDNA status accurately predicts patient survival and identifies who benefits from chemotherapy. Furthermore, the DYNAMIC study showed that using ctDNA to guide treatment decisions significantly reduced the use of unnecessary chemotherapy without compromising patient survival.\n\nIn Gastric Cancer: Studies such as MENCA-GC, CRITICS, and PLAGAST have confirmed that post-surgery ctDNA is a strong predictor of patient prognosis. Additionally, the MRD-GATE study provided preliminary evidence that ctDNA-guided strategies can reduce unnecessary chemotherapy in the adjuvant setting.\n\nBuilding on this evidence, this study applies ctDNA testing to the standard perioperative treatment model for gastric cancer. The primary objective is to determine if a ctDNA-guided strategy can identify patients who can safely forgo post-surgery chemotherapy, thereby reducing treatment toxicity and unnecessary usage, without sacrificing long-term survival outcomes.",[25],[25,188,189,190],"Circulating Tumor DNA","Minimal Residual Disease","Perioperative treatment","2025-11-20",{"date":193,"type":33},"2025-12-02",{"date":195,"type":21},"2025-12-30",{"date":172,"type":21},{"name":39,"class":40},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":51,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100605356","phase-4-comparing-the-efficacy-and-safety-of-different-postoperative-adjuvant-regimens-in-patients-with-resectable-adenocarcinoma-of-the-esophagogastric-junction-who-underwent-radical-surgery-after-neoadjuvant-chemotherapy-combined-with-immunotherapy-and-achieved-pcr-in-postoperative-pathology-100605356","NCT07161453","Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology","A Multicenter, Prospective, Real-world Study Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender not restricted;\n2. Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;\n3. HER2 overexpression or amplification results are negative;\n4. Subjects who have received neoadjuvant chemotherapy for GC\u002FGEJC before, and have undergone at least 3-4 cycles;\n5. Having undergone radical surgical treatment and with postoperative pathological result reaching pCR\n6. After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.\n\nExclusion Criteria:\n\n* 1\\) Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types; 2) Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency; 3) Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and\u002For had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 4) Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated); 5) Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;",{"count":206,"type":21},500,[208],"PHASE4","This study is to evaluate the efficacy and safety of different postoperative adjuvant regimens in patients with resectable adenocarcinoma of the esophagogastric junction who underwent radical surgery after neoadjuvant chemotherapy combined with immunotherapy and achieved pCR in postoperative pathology",[25],"2025-08-30",{"date":213,"type":33},"2025-09-08",{"date":215,"type":21},"2025-09-30",{"date":217,"type":21},"2027-12-31",{"name":219,"class":40},"Liaoning Cancer Hospital & Institute",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":51,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100604412","phase-4-comparing-the-efficacy-and-safety-of-chemotherapy-combined-with-or-without-immunotherapy-as-postoperative-adjuvant-regimens-in-patients-with-resectable-gastric-canceradenocarcinoma-of-the-esophagogastric-junction-after-radical-surgery-100604412","NCT07149181","Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as Postoperative Adjuvant Regimens in Patients With Resectable Gastric Cancer\u002FAdenocarcinoma of the Esophagogastric Junction After Radical Surgery","A Multicenter, Prospective, Real-world Study Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as Postoperative Adjuvant Regimens in Patients With Resectable Gastric Cancer\u002FAdenocarcinoma of the Esophagogastric Junction After Radical Surgery","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender not restricted;\n2. Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;\n3. HER2 overexpression or amplification results are negative;\n4. After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.\n\nExclusion Criteria:\n\n1. Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types;\n2. Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency;\n3. Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and\u002For had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding;\n4. Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated);\n5. Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;",{"count":228,"type":21},1000,[208],"This study is to evaluate the efficacy and safety of chemotherapy combined with or without immunotherapy as postoperative adjuvant regimens in patients with resectable gastric cancer\u002Fadenocarcinoma of the esophagogastric junction after radical surgery",[25],"2025-08-23",{"date":234,"type":33},"2025-08-29",{"date":236,"type":21},"2025-08-31",{"date":238,"type":21},"2028-09-30",{"name":219,"class":40},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":51,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":255,"leadSponsor":256,"locationsCount":4},"100603131","phase-4-comparing-the-efficacy-and-safety-of-chemotherapy-combined-with-or-without-immunotherapy-as-an-adjuvant-treatment-after-radical-surgery-for-patients-with-resectable-adenocarcinoma-of-the-esophagogastric-junction-of-gastric-cancer-100603131","NCT07132528","Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer","A Multicenter, Prospective, Real-world Study Comparing the Efficacy and Safety of Chemotherapy Combined With or Without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender not restricted;\n2. Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;\n3. HER2 overexpression or amplification results are negative;\n4. Subjects who have received neoadjuvant chemotherapy for GC\u002FGEJC before, and have undergone at least 3-4 cycles;\n5. After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.\n\nExclusion Criteria:\n\n1. Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types;\n2. Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency;\n3. Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and\u002For had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding;\n4. Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated);\n5. Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;",{"count":228,"type":21},[208],"This study is to evaluate the efficacy and safety of chemotherapy combined with or without Immunotherapy as an Adjuvant Treatment After Radical Surgery for Patients With Resectable Adenocarcinoma of the Esophagogastric Junction of Gastric Cancer",[25],"2025-08-17",{"date":253,"type":33},"2025-08-20",{"date":236,"type":21},{"date":238,"type":21},{"name":219,"class":40},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":51,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":104},"100602769","phase-2-assessing-iparomlimab-and-tuvonralimab-in-recurrent-or-metastatic-msi-hdmmr-gastric-cancer-100602769","NCT07127822","Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H\u002FdMMR Gastric Cancer","A Randomized, Controlled, Non Inferiority Phase II Clinical Study Comparing Iparomlimab and Tuvonralimab With Standard Chemotherapy Combined With PD-1\u002FPD-L1 Monoclonal Antibody as First-line Treatment for MSI-H\u002FdMMR Recurrent\u002FMetastatic Gastric Cancer","Inclusion Criteria:\n\n1\\. Voluntarily willing to participate in the study and sign the written informed consent form 2. Age ≥18 years male or female . 3. Expected survival time ≥ 3 months 4. Patients with unresectable locally advanced, recurrent, or metastatic gastric\u002Fgastroesophageal junction adenocarcinoma diagnosed by histological or cytological examination: 5. Confirmed by PCR or next-generation sequencing(NGS) as microsatellite instability-high(MSI-H) . Patients with mismatch repair defecient identified by immunohistochemistry need to undergo PCR\u002FNGS verification as MSI-H before treatment 6. Patients should not receive systematic anti-tumor treatment before, and for those who have received induction chemotherapy, concurrent radiochemotherapy, or neoadjuvant\u002Fadjuvant chemotherapy for curative purposes, the recurrence time must be at least 6 months from the end of the last treatment; 7. Agree to provide archived tumor tissue specimens or fresh tissue samples of primary or metastatic lesions within 3 years; If the patinet is unable to provide tumor tissue samples, they can be enrolled after evaluation by the researcher, provided that they meet other inclusion and exclusion criteria; 8. Patients must have at least one measurable lesion defined by RECIST 1.1. 9. European Cooperative Oncology Group (ECOG) ≤1 10. No severe cardiac dysfunction, left ventricular ejection fraction ≥ 50%; 11. Patients must meet the following criteria at screening and before preconditioning (baseline). If any laboratory test result is abnormal referring to the following criteria,\n\n1. Hematology: neutrophils (NE) ≥1.5×109 per liter, , platelets (PLT) ≥100×109per liter and hemoglobin (Hb) ≥8.0 g\u002FdL.\n2. Blood chemistry: creatinine clearance ≥50 mL\u002Fmin, Creatinine (Cr) ≤ 1.5 × ULN, alanine aminotransferase (ALT) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, aspartate aminotransferase (AST) ≤2.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 5 × ULN）, total bilirubin (TB) ≤1.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 3 × ULN）,\n3. International normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 12. Urinary protein ≤ 2+or \\\u003C 1000mg\u002F24h; 13. Women of childbearing potential must have negative serum pregnancy test result at screening and before preconditioning and agree to use an effective and reliable contraceptive method for at least 1 year after the last study treatment. Te acceptable methods include bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Previous use of PD-1\u002FPD-L1 monoclonal antibodies, CTLA-4 monoclonal antibodies, or monoclonal and bispecific drugs containing the aforementioned targets;\n3. Existence of any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma in which subjects require bronchodilators for medical intervention cannot be included); However, the following diseases are allowed to be included: vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment;\n4. Patients who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppressive goals (calculated as prednisone, dose\\>10mg\u002Fday or other therapeutic hormones) and continue to use it within 2 weeks of the first administration;\n5. Patients with uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;\n6. Patients with uncontrollable symptoms of brain metastasis, spinal cord compression, malignant meningitis, or brain or pia mater diseases detected by CT or MRI examination during screening within 4 weeks before the first administration\n7. Patients who have received non systematic anti-tumor therapy within 3 weeks prior to the start of treatment, including but not limited to surgery, radiation therapy, interventional therapy, and anti-tumor traditional Chinese medicine treatment (based on the indications in the Chinese medicine instructions, and may also be enrolled after a 2-week washout period). Patients whose adverse events caused by previous treatment (excluding hair loss) have not recovered to ≤ CTCAE grade 2 are not within the above range;\n8. Patients with any severe and\u002For uncontrolled illnesses, including:\n\n1\\) Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg) 2) Patients who experience unstable angina, myocardial infarction, ≥ grade 2 congestive heart failure, or arrhythmia requiring treatment within 6 months of initial administration (including QTc ≥ 480ms); 3) Active or uncontrolled severe infection (≥ CTCAE grade 2 infection); 4) A history of clinically significant liver disease, including viral hepatitis, known as a carrier of hepatitis B virus (HBV), must exclude active HBV infection, i.e. HBV DNA positive (\\>2000 IU\u002FmL); Known hepatitis C virus infection (HCV) and HCV RNA positivity (\\>1 × 103 copies\u002FmL), or other decompensated liver diseases or chronic hepatitis requiring antiviral therapy; 5) HIV test positive 6) Poor control of diabetes (fasting blood glucose ≥ CTCAE level 2); 9. Patients who have experienced severe infections (CTCAE\\>grade 2) within the first 4 weeks of randomization, such as severe pneumonia, bacteremia, sepsis, tuberculosis, etc; Indications of pulmonary infection or active pulmonary inflammation within the first 2 weeks of randomization; 10. Patients with a history of allergies to recombinant humanized antibodies who are allergic to any excipient components of the drug; 11. History of autologous or allogeneic stem cell transplantation; 12. Patients with a history of serious neurological or psychiatric disorders, including but not limited to: dementia, depression, epileptic seizures, bipolar disorder, etc; 13. Patients diagnosed as active malignant tumor within the first 3 years of randomization, except for the following cases: radical skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ and\u002For radical resection of carcinoma in situ, which the researchers think can be included; 14. Patients who plan to receive live vaccines within 28 days prior to randomization; 15. Researchers evaluate situations where participation in this clinical trial is inappropriate due to complications or other reasons.",{"count":265,"type":21},106,[162],"A randomized controlled phase II study exploring first-line treatment options for recurrent\u002Fmetastatic MSI-H gastric cancer",[25,269],"MSI-H Cancer","2025-08-15",{"date":251,"type":33},{"date":273,"type":21},"2025-09-01",{"date":275,"type":21},"2028-12-31",{"name":277,"class":40},"Peking University",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":136,"enrollmentInfo":285,"targetDuration":4,"studyType":51,"phases":287,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":4},"100600050","pucotenlimab-combined-with-chemotherapy-as-perioperative-treatment-for-locally-advanced-gastroesophageal-junction-carcinoma-100600050","NCT07092449","Pucotenlimab Combined With Chemotherapy as Perioperative Treatment for Locally Advanced Gastroesophageal Junction Carcinoma","Pucotenlimab Combined With Chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin) in the Perioperative Treatment of Locally Advanced Gastroesophageal Junction Tumors, A Multi-center Prospective Study","Inclusion Criteria:\n\n1. Informed Consent Provide written informed consent for the clinical study and biobank before any study-related procedures.\n2. Age and Gender Male or female patients aged 18 to 75 years.\n3. Disease Diagnosis Histologically confirmed resectable locally advanced gastroesophageal junction tumor.\n\n   cTNM staging of cT2N+M0 or cT3-4bNxM0 based on endoscopic ultrasonography, contrast-enhanced CT\u002FMRI (with endoscopic ultrasonography, diagnostic laparoscopy, or PET-CT as needed), corresponding to locally advanced gastroesophageal junction tumor per AJCC 9th edition, and deemed resectable by the investigator.\n4. Prior Treatment History No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy\u002Fchemotherapy, immunotherapy, etc.\n5. Surgical Eligibility Agree to receive radical surgery and have no surgical contraindications as judged by surgeons.\n6. Target Lesion Assessment At least one lesion (untreated with radiotherapy) meets RECIST 1.1 target lesion (TL) criteria.\n\n   Tumor assessment must be performed via CT or MRI within 28 days before treatment.\n7. Performance Status ECOG score of 0-1.\n8. Life Expectancy Expected survival ≥ 3 months.\n9. Organ Function Requirements\n\nLaboratory parameters must meet the following within 14 days:\n\nAbsolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL (without granulocyte colony-stimulating factor use).\n\nPlatelets ≥ 100×10⁹\u002FL (without blood transfusion). Hemoglobin \\> 9 g\u002FdL (without blood transfusion or erythropoietin use). Total bilirubin ≤ 1.5×ULN; if total bilirubin \\> 1.5×ULN, direct bilirubin must be ≤ ULN.\n\nAST and ALT ≤ 2.5×ULN. Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n\nCoagulation function: INR or PT ≤ 1.5×ULN. No severe thyroid dysfunction (as judged by the investigator). Cardiac function: NYHA class \\\u003C 3; left ventricular ejection fraction ≥ 50%. 10. Contraceptive Measures and Pregnancy Testing\n\nFor female subjects of childbearing potential:\n\nNegative urine or serum pregnancy test within 3 days before the first study drug administration (Cycle 1, Day 1). If urine test is inconclusive, a blood test is required.\n\nNon-childbearing potential is defined as postmenopausal for ≥1 year, surgically sterilized, or having undergone hysterectomy.\n\nAll subjects (male and female) at risk of conception must use contraception with an annual failure rate \\\u003C 1% throughout treatment and for 120 days after the last study drug administration (or 180 days after the last chemotherapy dose).\n\nExclusion Criteria:\n\n1. Diagnosed with malignant diseases other than gastroesophageal junction tumors within 5 years before the first administration (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ after radical resection);\n2. Known endoscopic evidence of active bleeding in the lesion;\n3. Known evidence of distant metastasis;\n4. Currently participating in therapeutic interventions of an interventional clinical study, or having received other drug therapies for malignant gastroesophageal junction tumors within 4 weeks before the first administration;\n5. Having previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.), or chemotherapy (including but not limited to S-1);\n6. Having received systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding those used locally to control pleural effusion) within 2 weeks before the first administration;\n7. Having had active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, glucocorticoids or immunosuppressants) within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment;\n8. Receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other forms of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (≤ 10 mg\u002Fday of prednisone or equivalent drugs) is allowed;\n9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n10. Known history of allergy to putlizumab, chemotherapeutic drugs used in this study or their components;\n11. Before starting treatment, not having fully recovered from toxicities and\u002For complications caused by any interventions (i.e., ≤ Grade 1 or returning to baseline, excluding fatigue or alopecia);\n12. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibodies);\n13. Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number greater than the upper limit of normal of the laboratory in the research center);\n\nNote: Hepatitis B subjects meeting the following criteria can also be enrolled:\n\n1\\) HBV viral load \\\u003C 1000 copies\u002Fml (200 IU\u002Fml) before the first administration, and subjects should receive anti-HBV treatment during the entire study period of chemotherapeutic drug treatment to avoid viral reactivation; 14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); 15. Having received a live vaccine within 30 days before the first administration (Cycle 1, Day 1); Note: Administration of inactivated viral vaccines for seasonal influenza within 30 days before the first administration is allowed; however, intranasal attenuated live influenza vaccines are not allowed; 16. Pregnant or lactating women; 17. Having any severe or uncontrollable systemic diseases, such as:\n\n1. Significant and severely symptomatic abnormalities in resting electrocardiogram in terms of rhythm, conduction or morphology, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias or atrial fibrillation;\n2. Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥ 2;\n3. Any arterial thrombosis, embolism or ischemia occurring within 6 months before enrollment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;\n4. Poorly controlled hypertension with medication;\n5. A history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or currently having clinically active interstitial lung disease;\n6. Active pulmonary tuberculosis;\n7. Having active or uncontrolled infections requiring systemic treatment;\n8. Having clinically active diverticulitis, abdominal abscess, intestinal obstruction;\n9. Liver diseases such as decompensated liver disease, acute or chronic active hepatitis;\n10. Poorly controlled diabetes;\n11. Patients with mental disorders who cannot cooperate with treatment; 18. Known dihydropyrimidine dehydrogenase deficiency; 19. Patients with gastrointestinal obstruction, or physiological dysfunction or malabsorption syndrome; Evidence of medical history, diseases, treatments or abnormal laboratory test values that may interfere with the study results, prevent the subjects from participating in the study throughout the process, or other situations that the researcher deems unsuitable for enrollment, or the researcher deems that there are other potential risks that make the subject unsuitable for participating in this study.",{"count":286,"type":21},30,[288],"NA","This study is a prospective, multicenter, single-arm clinical trial.\n\nThe study intends to enroll patients with pathologically or cytologically confirmed resectable locally advanced gastroesophageal junction tumors (cT2N+M0 and cT3-4bNxM0) who have not received prior systemic therapy. After signing the informed consent and being screened to meet the inclusion and exclusion criteria, patients will receive 3 cycles of Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin). Preoperative imaging evaluations will be performed 3 to 6 weeks after the final dose administration to assess the efficacy of neoadjuvant therapy and the feasibility of radical resection. Efficacy evaluation will be performed after radical surgery for locally advanced gastroesophageal junction tumors.",[291,25,292,293],"Gastroesophageal Junction","Neoadjuvant Chemoimmunotherapy","Adjuvant Therapy",[295],"A Prospective Observational Study of Putilimab Combined with Chemotherapy in the Perioperative Treatment of Locally Advanced Gastroesophageal Junction Tumors","2025-07-22",{"date":298,"type":33},"2025-07-29",{"date":300,"type":21},"2025-08-01",{"date":217,"type":21},{"name":303,"class":40},"Tang-Du Hospital",{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":51,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":104},"100547319","phase-2-study-of-the-second-line-treatment-of-advanced-gastric--gastroesophageal-junction-adenocarcinoma-with-cadonilimab-and-fruquintinib-combined-with-paclitaxel-albumin-100547319","NCT06406426","Study of The Second-line Treatment of Advanced Gastric \u002F Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin","An Open and Exploratory Study of The Second-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin","Inclusion Criteria:\n\nSigned written informed consent prior to enrollment. Age 18-80 years. Negative for HER2 Diagnosis confirmed by histological examination and\u002For cytological examination combined with imaging assessment of advanced metastatic gastric\u002Fgastroesophageal junction adenocarcinoma.\n\nFailure of previous first-line therapy. Group A (immunotherapy naive ): patients who have failed prior chemotherapy with first-line standard therapy. Group B (immunotherapy rechallenge): patients who had previously failed PD-1\u002FL1 antibody combined chemotherapy in the first line.\n\nECOG score: 0 to 1. At least one measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to iRECIST criteria).\n\nAdequate organ function with. Routine blood: Absolute Neutrophil Count (ANC) 1.5 × 109\u002FL, Platelets (Platelet, PLT) ≥ 100 × 109\u002FL, Hemoglobin (HGB) ≥ 90 g\u002FL.\n\nLiver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; serum albumin ≥30 g\u002FL; after conventional hepatoprotective treatment meeting the above criteria, and can be stable for at least 1 week after evaluation by the investigator can be enrolled.\n\nRenal function: Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmi (applying the standard Cockcroft-Gault formula).\n\nCoagulation function: International Normalized Ratio (INR) ≤ 1.5 \u002FPT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation therapy, as long as PT and INR are within the range drawn up by anticoagulant drugs.\n\nA predicted survival of ≥ 3 months. Female patients must be non-pregnant and non-lactating and are required to use a medically approved form of contraception (e.g., IUD, pill or condom) during study treatment and for at least 120 days after study completion, and are not allowed to donate eggs to another person or freeze them for fertilization and propagation during this period.\n\nExclusion Criteria:\n\nSymptomatic brain metastases. Known MSI-H\u002FdMMR. A prior history of a primary tumor outside of the gastric\u002Fgastroesophageal junction in 3 years Active autoimmune disease or autoimmune disease with potential for recurrence such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; subjects with vitiligo or complete remission of asthma in childhood and adult who do not require any intervention afterwards can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.\n\nSubjects with any severe and\u002For uncontrolled disease. including. Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL) Having ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470ms) and ≥ grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification) Active or uncontrolled severe infection (≥ CTCAE grade 2 infection) requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection Active hepatitis (transaminases do not meet the inclusion criteria, hepatitis B reference: HBV DNA ≥ 1000 IU\u002Fml or ≥ 10\\^4 copies\u002Fml; hepatitis C reference: HCV RNA ≥ 1000 IU\u002Fml or ≥ 10\\^4 copies\u002Fml; after nucleotide based antiviral therapy below the above criteria, can be enrolled); chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002Fml, who must receive concomitant antiviral therapy during the trial to be enrolled.\n\nThose with renal failure requiring hemodialysis or peritoneal dialysis. Those with a history of immunodeficiency, including HIV-positive or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the start of study treatment, except for replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency); receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Doses \\>10 mg\u002Fday of prednisone or other equivalent hormone and within 2 weeks of the first dose and still continuing Those with a history of active tuberculosis Those who fail to control and still require repeated drainage of ascites, pericardial effusion, pleural effusion.\n\nResearch treatment related to. Patients who have undergone major organ transplantation Those who have undergone major surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to the start of study treatment; or have a long-standing untreated wound or fracture History of live attenuated vaccination within 14 days prior to the start of study treatment or planned live attenuated vaccination during the study History of severe hypersensitivity reactions following the use of monoclonal antibodies; known hypersensitivity to active ingredients or excipients such as envafolimab, lenvatinib, etc., of this study drug Those who are participating or have participated in other clinical studies within 4 weeks prior to the start of the study Those who have received taxanes, anti-angiogenic agents, and dual immunotherapy during first-line treatment.\n\nThose with a history of severe allergy. Women who are pregnant or breastfeeding At risk for bleeding, or with coagulation disorders, or undergoing thrombolytic therapy Those with a history of psychotropic substance abuse and unable to abstain or with psychiatric disorders Subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or subjects for whom other reasons are deemed to exist that make them unsuitable for enrollment In the judgment of the investigator, subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or subjects for whom other reasons are deemed to exist that make them unsuitable for enrollment.","80 Years",{"count":313,"type":21},40,[162],"This study is a prospective, open-label, two-arm exploratory Phase II clinical trial aimed at observing and evaluating the efficacy and safety of combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin as second-line treatment for advanced gastric\u002Fesophagogastric junction adenocarcinoma. Patients meeting the inclusion criteria were divided into two groups based on whether they had received PD-1\u002FL1 antibody treatment in the first line: Group A (immunotherapy-naive group - patients who had previously failed standard chemotherapy in the first line) and Group B (immunotherapy rechallenge group - patients who had previously failed PD-1\u002FL1 antibody combined chemotherapy in the first line). All patients received combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin until intolerable toxic reactions occurred, disease progression, withdrawal of informed consent by the subject, loss to follow-up, death, other conditions judged by the investigator to require termination of treatment, or termination of the study, whichever occurred first. The maximum duration of paclitaxel-albumin treatment was 6 cycles, and cadonilimab treatment did not exceed 1 year. Clinical tumor imaging evaluations were conducted every 8 weeks during treatment using RECIST v1.1 criteria, and safety assessments were performed using CTCAE 5.0, recording adverse events within 30 days from the first dose to the end of treatment.",[25],"2024-05-06",{"date":319,"type":33},"2024-05-09",{"date":321,"type":21},"2024-05-01",{"date":323,"type":21},"2026-09-01",{"name":325,"class":40},"Fudan University"]