[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stomach-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stomach-neoplasm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,45,71,93,119,146,178,202,246,269,289,315,336,373,394],{"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":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100492964","rehabilitation-and-recovery-for-persons-with-esophageal-or-gastric-cancer-100492964",false,"NCT05698992","Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer","Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer - a Clinical Trial Evaluating and Implementing a Model for Evidence-based Cancer Rehabilitation","Inclusion Criteria:\n\n* over 18 years of age\n* esophageal or gastric cancer\n* living in Southern Sweden (Skåne)\n* are planned to undergo curative surgerytreatment at Skåne University Hospital.\n\nExclusion Criteria:\n\n* unable to communicate in the Swedish language\n* suffering from a cognitive impairment that poses a barrier for participating in the study.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","15 Months","OBSERVATIONAL","This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.",[25,26,27,28],"Esophageal Cancer","Esophageal Neoplasms","Gastric Cancer","Stomach Neoplasm",[30,31],"Cancer rehabilitation","Recovery","RECRUITING","2026-05-12",{"date":35,"type":36},"2026-05-15","ACTUAL",{"date":38,"type":36},"2023-02-27",{"date":40,"type":20},"2027-12-31",{"name":42,"class":43},"Region Skane","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":69,"locationsCount":44},"100453458","phase-2-a-phase-2-study-of-neoadjuvant-docetaxel-oxaliplatin-s-1-in-patients-with-unresectable-locally-advanced-or-distant-metastasis-limited-to-lymph-node-gastric-cancer-100453458","NCT05184803","A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically proven metastatic gastric adenocarcinoma patients\n2. As a patient who has been proven by CT to have invasion of surrounding organs (T4) according to the 8th edition of the American Joint Commission (AJCC) or confined to remote lymph nodes, the criteria for lymph node invasion are 8 mm or more in single diameter and central necrosis (rounder), (Refer to Appendix B)\n3. Over 18 years old.\n4. Patients with a life expectancy of at least 3 months.\n5. Patients with 0 or 1 ECOG performance status\n6. As defined in the relevant items below, those who have confirmed appropriate normal organ and bone marrow function:\n\n   * Haemoglobin 9 9.0 g\u002FdL.\n   * Absolute neutrophil count (ANC) \\> 1.5 x 103\u002FmCL (\\> 1,500 per mm3)\n   * Platelet count 100 100 x 109\u002FL\n   * Serum bilirubin 1.5 1.5 x Test Laboratory Upper Limit of Normal (ULN).\n   * AST(SGOT)\u002FALT(SGPT) 2.5 2.5x ULN of test institution.\n   * Measured creatinine clearance (CL) \\> 40 mL\u002Fmin or Cockcroft-Gault formula (Cockcroft and Gault 1976) calculated by or according to 24-hour urine samples for determining creatinine cleaning rates.\n\n     * Male creatinine CL (mL\u002Fmin) = Weight (kg)x (140-age) \u002F 72x Serum creatinine (mg\u002FdL)\n     * Women's creatinine CL (mL\u002Fmin) = Weight (kg)x (140-age) \u002F 72 x Serum creatinine (mg\u002FdL) x 0.85\n7. A patient who has never had chemotherapy before.\n8. Patients who have not previously had radiation therapy experience\n9. Physical, family, social, and geographic conditions for the follow-up of patient conditions required for this study should be free of obstacles in this study.\n10. Evidence of menopause or negative findings of urine or blood pregnancy response should be confirmed in premenopausal women. Women who are premenstrual for more than 12 months without any other medical cause are considered menopause. In addition, if bilateral ovarian resection, bilateral ovariectomy, and hysterectomy are performed, menopause is considered.\n11. Subjects who can provide signed consent, such as compliance with the requirements and taboos specified in the test subject's consent (ICF) and this plan. Written consent must be obtained from the patient and the patient's legal representative prior to implementing the plan-related procedures, including screening evaluation.\n\nExclusion Criteria:\n\n1. When pregnant women, lactating women, or pregnant women do not use appropriate contraception methods.\n2. Cancer other than adenocarcinoma.\n3. Patients with distant metastasis other than lymph nodes or confirmed ascites on abdominal CT before surgery.\n4. History of other carcinomas or presence of pathogenic cancer (excluding non-melanoma skin cancer or cervical epithelial cancer)\n5. Central nervous system metastasis.\n6. Clinically significant intestinal obstruction or gastrointestinal bleeding.\n7. A patient with a history of organ transplantation.\n8. Active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV identified by TB tests according to medical history, physical examination, radiological findings, and regional standards.\n\n   * Tuberculosis: Tuberculosis confirmed by medical history, physical examination, or radiologically active tuberculosis, and tuberculosis tests according to regional standards (excluding active TB, old TB is acceptable)\n   * Hepatitis B: If HBsAg is negative, register, and if HBsAg is positive, HBV DNA test is performed.\n\n     * HBV DNA 500 500iu\u002Fml (or 2500 copies\u002Fml): Excluded\n     * HBV DNA ▶500iu\u002Fml (or 2500 copies\u002Fml): Allow\n   * Hepatitis C: If HCV Ab is negative, register, and if HCV Ab is positive, HCV RNA test is performed.\n\n     * If HCV RNA is positive, I'll exclude it.\n     * If it's HCV RNA's voice, it's allowed.\n   * HIV: HIV Ag\u002FAb : excluding reactive faces, HIV Ag\u002FAb : non-reactive faces registration\n9. Average QTcF (average QT interval for heart rate correction using fridericia formula) \\> 470 ms when calculated with three ECG tests (within 15 minutes at 2-5 minute intervals).\n\n   If -1 test is performed and QTcF \\> 470 ms, 2 additional tests are performed to determine the average QTcF value.\n\n   -If QTcF 4 470 ms after one test, no additional test is performed.\n10. Other serious diseases or medical conditions.\n\n    * Uncurable unstable heart disease, myocardial infarction within 6 months before the start of the study.\n    * A history of neurological or psychiatric diseases including dementia or seizures.\n    * Active, non-regulatory infection.\n    * Clinically serious diarrhea.\n    * Severe high calcium conditions above 12 mg\u002FdL, which are not controlled by phonates.\n    * Other serious medical conditions that may affect participation in this study.\n    * Active random intravascular coagulation.\n11. Patients who other researchers find inappropriate.\n12. In the case of recent corticosteroids (or corresponding) treatment, except for acute hypersensitivity response therapy or low-dose (\\\u003C20 mg methylprednisolone or corresponding) chronic treatment (started 6 months before the start of the study) as preventive therapy,\n13. In addition to the test drug, administration of other clinical research drugs within 4 weeks or in combination.\n14. Combination chemotherapy, hormone therapy, or immunotherapy.","19 Years",{"count":53,"type":20},63,"INTERVENTIONAL",[56],"PHASE2","Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ or distant metastasis. Many assisted chemotherapy has been studied to improve survival rate, and in East Asia, assisted chemotherapy after complete D2 resection is the standard treatment. In the West, on the other hand, preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments. However, due to the limited effect of adjuvant chemotherapy, it has been reported that better clinical course can be improved by increasing anticancer intensity.\n\nIn this context, a large number of prior chemotherapy have been attempted, and prior chemotherapy has several potential effects as follows. (1) Improvement of R0 resection rate due to reduced primary cancer size, (2) early treatment for micro metastasis, (3) evaluation of treatment response rate in patients with measurable lesions, and (4) unnecessary laparotomy can be avoided in patients with biologically aggressive diseases.\n\nBased on the efficacy of chemotherapy in the combination of docetaxel, fluoropyrimidine, and platinum in metastatic gastric cancer, the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel, capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery. DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2. In a total of 49 patients, R0 resection was performed in 31 (63%), and among patients, R0 resection was improved in cases where resection was not possible due to local infiltration (71%) and in cases where para-aortic node metastasis was performed (73%).\n\nWe have reported that docetaxel, oxaliplatin, and S-1 chemotherapy (DOS) as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients. R0 resection was achieved in 97.6% of patients, and pathological complete remission was observed in 19.5%. Based on this, a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 (CSC group) as a preoperative prior chemotherapy compared to S-1 (SC group) as a postoperative adjuvant therapy in gastric cancer of cT2\u002F3N+ or cT4Nany stage, and 0.75% of the CSC group was administered HR. In the patient group undergoing surgery, the R0 resection rate was 95% in the CSC group and 84% in the SC group. In the CSC group, the pathological complete remission rate was 10.4%.\n\nBased on these results, a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes.\n\nPrimary goal: Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.\n\nSecondary objective: safety evaluation, overall survival period, progression-free survival period, pathological complete remission rate, and investigation of biological markers.",[28],[60,61,62],"Neo-adjuvant\u002FAdjuvant","distant metastasis limited to lymph node gastric cancer","unresectable locally advanced gastric cancer","2026-04-02",{"date":65,"type":36},"2026-04-07",{"date":67,"type":36},"2022-03-23",{"date":40,"type":20},{"name":70,"class":43},"Asan Medical Center",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":54,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":44},"100522679","phase-1-trastuzumab-deruxtecant-dxd-and-afatinib-combination-in-her2-low-advanced-gastric-cancer-100522679","NCT06085755","Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer","Ph 1\u002F2 Study of Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer(VIKTORY-2)","Inclusion Criteria:\n\n1. Provision of fully informed consent prior to any study specific procedures.\n2. Patients must be ≥ 19 years of age\n3. Has a pathologically documented advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction with at least one measurable lesion according to the modified RECIST 1.1 are eligible\n4. HER2-low (HER2 1+, HER2 2+ (SISH negative))\n5. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.\n6. ECOG performance status 0-1 with no deterioration between screening and the first dose of study treatment.\n7. Patients must have a life expectancy ≥ 3 months from proposed first dose date.\n8. Patients must have had a washout period of 2 weeks for any prior therapy prior to the start of study drug. The following intervals between the end of the prior treatment and first dose of study drug must be observed:\n\n   * Major surgery ≥ 4 weeks\n   * Radiation Therapy including palliative stereotactic radiation therapy to chest ≥ 4 weeks\n   * Palliative stereotactic radiation therapy to other anatomic areas including whole brain radiation ≥ 2 weeks\n   * Anti-Cancer chemotherapy \\[Immunotherapy (non-antibody based therapy)\\], retinoid therapy, hormonal therapy ≥ 3 weeks\n   * Antibody based anti-cancer therapy ≥ 4 weeks\n   * Targeted agents and small molecules ≥ 2 weeks or 5 half-lives, whichever is longer\n   * Nitrosoureas or mitomycin C ≥ 6 weeks\n   * TKIs approved for treatment of NSCLC ≥1 week (baseline CT scan must be completed after discontinuation of TKI\n   * Chloroquine\u002FHydroxychloroquine ≥ 14 days\n   * Cell-free and CART, peritoneal shunt or drainage of pleural effusion, ascites or pericardial effusion ≥ 2 weeks prior to screening assessment\n9. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:\n\n   * Hemoglobin ≥8.0 g\u002FdL (Red blood cell transfusion is not allowed within 1 week prior to the day)\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (G-CSF administration is not allowed within 2 weeks prior to the day)\n   * Platelet count ≥100 x 109\u002FL (Platelet transfusion is not allowed within 1 week prior to the day)\n   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or \\\u003C 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline\n   * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN\n   * Serum creatinine ≤1.5 x institutional ULN\n   * CrCl 30≥mL\u002Fmin as determined by Cockcroft Gault (using actual body weight)\n   * Serum albumin ≥ 2.5 g\u002FdL\n   * International normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN\n10. Female patients must be using a highly effective method of contraception (refer to the restrictions on P37) during the clinical trial and for 7 months after permanent discontinuation of the study drug. There must be evidence that patients are not breastfeeding, have a negative pregnancy test, or not of childbearing potential by meeting one of the following criteria at screening:\n\n    1. Post-menopausal women defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatment.\n    2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.\n    3. Amenorrhoeic for 12 months and serum follicle-stimulating hormone (FSH), lutenizing hormone (LH) and plasma oestradiol levels in the postmenopausal range for the institution More detailed information is provided in Appendix F (Definition and accepted contraception for women of childbearing age).\n11. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomisation\u002Fenrolment, throughout the study and for 4 months after the last dose of IMP. Preservation of sperm should be considered prior to enrollment in this study.\n12. Mandatory biopsy during the screening window prior to dosing and at progression\n\nExclusion Criteria:\n\n1. Medical history of myocardial infarction within 6 months before registration, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV, Section 17.4), troponin levels consistent with myocardial infarction as defined according to American College of Cardiology (ACC) guidelines, unstable angina, or serious cardiac arrhythmia requiring treatment.\n2. History of (non-infectious) ILD \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n3. Has a pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART). (Drainage and CART are not allowed within 2 weeks prior to screening assessment)\n4. Has uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.\n5. Active hepatitis B or C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1. Subjects with past or resolved hepatitis B virus (HBV) infection who are anti-HBc positive (+) are eligible only if they are HBsAg negative (-). Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n6. Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with treated brain metastases that are no longer symptomatic and who do not require treatment with steroids for at least three weeks may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment\u002Frandomization.\n7. Has clinically significant corneal disease in the opinion of the investigator.\n8. Prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.\n\n   Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than chronic toxicities per the discretion of the investigator, eg, alopecia, peripheral neuropathy, proteinuria, controllable hypertension, and controllable diabetes) not yet resolved to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, Grade ≤1 or baseline. Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to \\[randomization\u002Fenrollment\u002FCycle 1 Day 1\\] and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as:\n   * Chemotherapy-induced neuropathy\n   * Fatigue\n   * Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include:\n\n     1. Hypothyroidism\u002Fhyperthyroidism\n     2. Type 1 diabetes\n     3. Hyperglycaemia\n     4. Adrenal insufficiency\n     5. Adrenalitis\n     6. Skin hypopigmentation (vitiligo)\n9. Any gastrointestinal condition that would preclude adequate absorption of afatinib including but not limited to inability to swallow oral medication, refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.\n10. Active or prior documented autoimmune or inflammatory disorders (including IBD \\[e.g. Chohn's disease, ulcerative colitis or diverticulitis\\], SLE, sarcoidosis syndrome, tuberculosis, Wegener syndrome, myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, at screening. Adjust wording as necessary and consider evaluating at screening for studies with known hepatotoxicity or other relevant requirements, history of organ transplant that requires use of immunosuppressives, glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis within the past 2 years prior to the start of treatment. The following are exceptions to this criterion:\n\n    * Subjects with vitiligo or alopecia, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment; patients with coeliac disease controlled by diet alone and patients without active disease in the last 5 years may be included after consultation with Chief Investigator.\n    * HbsAg carrier without active viral infection and under entecavir prophylaxis will be allowed.\n11. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice). Active or prior documented history of primary immunodeficiency or HIV infection, at screening.\n12. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Note: Subjects previously treated for CNS metastases that are asymptomatic, radiographically and neurologically stable for at least 4 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 4 weeks prior to the first dose of treatment are not excluded.\n13. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≤3 years.\n14. Patient was in receipt of any live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study therapy.\n15. Patients currently receiving (or unable to stop use at least 2 weeks) prior to receiving the first dose of afatinib, medications known to be potent inhibitors of CYP1A2 or strong inducers of CYP3A4 with a narrow therapeutic range\n16. Patient with any of the following cardiac criteria:\n\n    * Mean QT interval corrected for heart rate (QTc) ≥ 470 ms calculated from electrogram (ECG) using Friderecia's correction\n    * Any clinicallly important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block, second degree heart block, PR Interval \\>250 msec.\n    * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncorrectable chronic hypokalaemia, congenital long QT syndrome, family history (first-degree relatives) of long QT syndrome or unexplained sudden death under 40 years of age or concomitant medication known to prolong the QT interval\n    * Uncontrolled hypotension: systolic BP \\\u003C 90 mmHg and\u002For diastolic BP 60 mmHg or clinically relevant orthostatic hypotension, including a fall in blood pressure of \\> 20 mmHg\n    * Atrial fibrillation with a ventricular rate \\>100 bpm on ECG at rest\n    * Symptomatic heart failure (NYHA grade II-IV)\n    * Known reduced LVEF \\\u003C 55%\n    * Prior or current cardiomyopathy\n    * Prior or current acute myocardial infarction\n    * Severe valvular heart disease\n    * Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy)\n    * Stroke or transient ischaemic attack in prior to screening\n    * Acute coronary syndrome within 6 months prior to starting treatment\n17. Any evidence of severe or uncontrolled systemic disease, including active infection (requiring antibiotics, antifungals or antivirals), diabetes type I and II, uncontrolled seizures, bleeding diatheses, severe COPD, severe Parkinson's disease.\n18. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n\n    For unresolved toxicity, A.Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the PI.\n\n    B.Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with Trastuzumab deruxtecan may be included only after consultation with the PI\n19. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n20. History of active primary immunodeficiency\n21. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 7 months after the last dose of Trastuzumab deruxtecan and Afatinib.\n22. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n23. History of allogenic organ transplantation.\n24. Lung criteria:\n\n    * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)\n    * Any autoimmune, connective tissue or inflammatory disorders (e.g. Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the CRF for patients who are included in the study.\n    * Prior pneumonectomy (complete)",{"count":79,"type":20},61,[81,56],"PHASE1","Despite recent advances, the prognosis of patients with advanced gastric cancer remains poor. At present, regimens that combine a platinum and fluorouracil agent either alone or in combination with a third drug such as epirubicin or taxane constitute the most effective treatment option in the first-line metastatic setting, resulting in a median OS of approximately 10 months. In the second-line setting, ramucirumab (a vascular endothelial growth factor receptor 2 antagonist) was recently approved by the United States Food and Drug Administration, and has demonstrated modest activity in patients with advanced gastric or GEJ adenocarcinoma who progressed after first-line platinum- or fluoropyrimidine-containing chemotherapy. Median OS was 5.2 months in the ramucirumab group versus 3.8 months in the placebo group.\n\nAt the updated DCO of 03 June 2020 in the DS8201-A-J202 (DESTINY-Gastric01) study in HER2-positive GC or GEJ adenocarcinoma subjects assigned to T-DXd 6.4 mg\u002Fkg, T-DXd further demonstrated clinically meaningful efficacy. The median OS was 12.5 months for the T-DXd group and 8.9 months for the physician's choice group (HR = 0.60, 95% CI: 0.42, 0.86). In a prespecified subgroup analysis, the percentages of patients with an objective response were analyzed in HER2-low group. The response rate in HER2 2+ was 29% (8 of 28) with T-DXd monotherapy.\n\nRefer to the figure below for the response rate in HER2-low group in previous DESTINY trials.\n\nThis is a two part, phase I\u002FⅡ, open-label, single center study of afatinib in combination with T-DXd, in 2L\u002F3L gastric cancer patients with HER2-low. The study design allows an investigation of combination dose of afatinib with T-DXd, with intensive safety monitoring to ensure the safety of the patients.",[28],"2025-12-08",{"date":86,"type":36},"2025-12-15",{"date":88,"type":36},"2024-09-30",{"date":90,"type":20},"2026-12",{"name":92,"class":43},"Jeeyun Lee",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":54,"phases":101,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":44},"100604405","phase-1-lenvatinib-in-combination-with-nivolumab-plus-chemotherapy-in-metastatic-gastric-cancer-patients-with-malignant-ascites-100604405","NCT07149090","Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites","A Clinical Trial Evaluating the Efficacy and Safety of Lenvatinib, Nivolumab, and Chemotherapy in Metastatic Gastric Cancer With Malignant Ascites.","Inclusion Criteria:\n\n1. Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma\n2. Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT)\n3. PD-L1 combined positive score of ≥5 based on the 28-8 assay\n4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations\n5. Age \\> 19 years at time of study entry\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Life expectancy of \\> 4 months\n8. Body weight \\> 30kg\n9. No existing neuropathy\n10. Adequate normal organ and marrow function as defined below:\n\n    * Hemoglobin ≥9.0 g\u002FdL\n    * Absolute neutrophil count (ANC) 1.5 x (\\> 1500 per mm3)\n    * Platelet count ≥100 (or 75) x 109\u002FL (\\>75,000 per mm3)\n    * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)\n    * AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional ULN\n    * Measured creatinine clearance (CL) \\> 40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance:\n11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n\nExclusion Criteria:\n\n1. Disease progression within 6 months after completion of adjuvant chemotherapy.\n2. Participation in another clinical study with an investigational product during the last 2 weeks\n3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n4. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n5. Major surgical procedure within 28 days prior to the first dose\n6. Unable to take medication orally\n7. Gastrointestinal bleeding\n8. Impaired bowel absorption\n9. History of allogenic organ transplantation\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent\n11. History of another primary malignancy except for\n\n    * Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose and of low potential risk for recurrence\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated carcinoma in situ without evidence of disease\n12. History of active primary immunodeficiency\n13. Active infectious disease\n14. Tuberculosis (based on clinical history, physical examination, radiographic findings, and TB testing in line with local practice)\n15. Hepatitis B (known positive HBV surface antigen (HBsAg) result)\n16. Hepatitis C (patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA)\n17. Human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n18. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible.\n19. Female patients who are pregnant or breastfeeding, as well as male or female patients of reproductive potential who are not willing to use effective contraception from the time of screening until 5 months following the final dose of lenvatinib.\n20. Known allergy or hypersensitivity to the investigational drug or any of its components.\n21. Patients with known deficiency of dihydropyrimidine dehydrogenase (DPD).\n22. Patients with known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.",{"count":79,"type":20},[81,56],"To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.",[104,27,105],"STOMACH NEOPLASM","Gastric Cancer Adenocarcinoma Metastatic",[107,108,109,110],"Stomach Neoplasms","Gastric cancer","Lenvatinib","Advanced Gastric Cancer","2025-11-19",{"date":113,"type":36},"2025-11-20",{"date":115,"type":36},"2025-11-11",{"date":117,"type":20},"2027-07-30",{"name":70,"class":43},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":54,"phases":128,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100453156","omentum-preservation-versus-complete-omentectomy-in-gastrectomy-for-gastric-cancer-100453156","NCT05180864","Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer","OMEGA-2","Inclusion criteria\n\n* Primary resectable gastric adenocarcinoma, clinical stage T1-4aN0-3M0\n* ASA 1-3 (able to undergo surgery)\n* Scheduled for open or minimally invasive (sub)total gastrectomy with modified D2-lymphadenectomy, with or without perioperative chemotherapy\n* Age above 18\n* Able to complete questionnaires in Dutch, English or Italian\n* Written informed consent\n* Esophageal invasion \\\u003C 2 cm defined from the upper margin of the gastric rugae as determined by endoscopy\n\nExclusion Criteria:\n\n* Gastric cancer clinically staged as T1N0\n* Locally advanced gastric cancer requiring multi-visceral resection\n* Pregnancy\n* Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \\\u003C2cm, and gastrointestinal stromal tumor (GIST) \\\u003C2cm), unless no evidence of disease and diagnosed more than three years before diagnosis of gastric cancer, or with a life expectancy of more than five years from date of inclusion\n* Serious concomitant systemic disorders that would compromise the safety of the patient or his\u002Fher ability to complete the study, at the discretion of the investigator\n* Previous gastric or omental surgery, with the exclusion of a gastric perforation Indication for thoracotomy\u002Fthoracoscopy",{"count":127,"type":20},654,[129],"NA","Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits.\n\nThe omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery.\n\nThere is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival.\n\nOMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (\\>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.",[28],[133,134,135],"Gastrectomy","Omentectomy","Survival","2025-08-28",{"date":138,"type":36},"2025-09-04",{"date":140,"type":36},"2024-03-01",{"date":142,"type":20},"2031-01-01",{"name":144,"class":43},"Amsterdam UMC",16,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":54,"phases":156,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100594378","phase-2-18ff-fapi-petct-and-laparoscopy-in-staging-advanced-gastric-cancer-100594378","NCT07018661","[18F]F-FAPI PET\u002FCT and Laparoscopy in Staging Advanced Gastric Cancer","[18F]F-FAPI PET\u002FCT and LAparoscopy in STagIng Advanced Gastric Cancer - a Multicenter Prospective Study","PLASTIC-3","Inclusion Criteria:\n\n* Histologically proven adenocarcinoma of the stomach or the esophagogastric junction (Siewert type III), by gastroscopy;\n* Age greater than or equal to 18 years;\n* Surgically resectable, advanced tumor (cT3-4b, N0-3, M0), as determined on gastroscopy and a contrast-enhanced CT of thorax and abdomen. Intention to perform a gastrectomy, based on a multidisciplinary team meeting and shared decision making;\n* Patients must have given written informed consent;\n* Patients who have recently participated in an interventional study with an investigational medicinal product (IMP) may only participate if an interaction with study procedures is deemed unlikely by the study team (e.g. based on mechanism or washout period).\n\nExclusion Criteria:\n\n* Siewert type I-II esophagogastric junction tumor;\n* Unfit or unwilling to undergo study procedures;\n* Unfit or unwilling to undergo surgery;\n* Pregnancy at time of the \\[18F\\]AlF-FAPI-74 PET\u002FCT scan, due to the investigational PET radiation burden;\n* Incapacitated subjects without decision-making capacity;\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent;\n* Illiterate patients unable to complete the resource use and quality of life questionnaires;\n* Inability to undergo PET\u002FCT scans due to factors such as claustrophobia, weight limits, or the inability to lie flat for the duration of the scan (approximately 30 minutes).",{"count":155,"type":20},250,[56,157],"PHASE3","The goal of this clinical trial is to learn if a new type of scan, FAPI-PET\u002FCT, can help find metastases of gastric cancer. We want to know how well this scan works for this purpose and whether it is less burdensome for patients compared to the methods we currently use to find metastases.\n\nThe main questions it aims to answer are:\n\n* In how many patients can FAPI-PET\u002FCT find metastases, which leads to a change in their treatment plan as decided by their medical team, such as avoiding unnecessary surgeries and changing from treatment meant to cure the disease to treatment focused on comfort (palliative treatment)?\n* In how many patients does FAPI-PET\u002FCT change the diagnostic process as decided by their medical team, like more biopsies or imaging, or changing the type (extent) of surgery needed?\n\nApart from the usual care gastric cancer patients receive, participants will:\n\n* Undergo one additional scan, which will take approximately 2 hours in total (excluding travel time)\n* Complete a number of questionnaires, which will take approximately 4 hours in total",[160,104,27,161],"Locally Advanced Gastric Adenocarcinoma","PET-CT",[163,164,165,166,133,27,167],"FAPI","18F-FAPI-74","PET\u002FCT","Imaging biomarker","Diagnostics","2025-08-20",{"date":170,"type":36},"2025-08-27",{"date":172,"type":36},"2025-07-03",{"date":174,"type":20},"2029-01",{"name":176,"class":43},"Leiden University Medical Center",10,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":54,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":200,"locationsCount":201},"100572406","phase-1-a-phase-ibii-trial-of-neoadjuvant-zolbetuximab-plus-docetaxel-oxaliplatin-and-s-1-chemotherapy-in-patients-with-locally-advanced-gastric-cancer-100572406","NCT06732856","A Phase Ib\u002FII Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer","NEO-CLAUD","Inclusion Criteria:\n\n1. Patients with newly diagnosed, pathologically confirmed, potentially resectable gastric or gastroesophageal junction adenocarcinoma\n2. Subjects who are CLDN18.2 positive (VENTANA 43-14A ≥75%)\n3. Patients with clinical stage T3-4\u002FN0 or T2-4\u002FN+ on CT according to the American Joint Committee on Cancer (AJCC) 8th edition\n4. If suspected by CT, patient who has not been confirmed to have peritoneal seeding by laparoscopy\n5. Subject able to provide signed informed consent form, including compliance with the requirements and contraindications specified in the informed consent form (ICF) and in this protocol\n6. Patients aged 19 years or older at study entry\n7. Patient with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n8. Patient with expected survival \\>12 months\n9. Weight \\>30 kg\n10. Patient without neuropathy A. Grade 1 is allowed based on NCI CTCAE v5.0. B. Grade 2 or higher is excluded based on NCI CTCAE v5.0\n11. Individual with confirmed adequate normal organ and bone marrow function, as defined in the applicable items below:\n\n    * Hemoglobin ≥9.0 g\u002FdL\n    * Absolute neutrophil count (ANC) \\>1.5 x 103\u002FmcL (\\>1,500 per mm3)\n    * Platelet count ≥100 x 109\u002FL\n    * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)\n    * AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional ULN\n    * Measured creatinine clearance (CL) \\>40 mL\u002Fmin or creatinine CL \\>40 mL\u002Fmin as calculated by Cockcroft-Gault formula (Cockcroft and Gault 1976) or based on a 24-hour urine sample for determination of creatinine clearance\n\n      1. Male creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) \u002F 72 x Serum creatinine (mg\u002FdL)\n      2. Female creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) \u002F 72 x Serum creatinine (mg\u002FdL) x 0.85\n12. Evidence of menopause, or negative urine\u002Fblood pregnancy test in premenopausal women; women with amenorrhea for at least 12 months without any other medical cause are considered menopausal. The following age requirements apply:\n\n    * A woman under age 50 is considered menopausal if 1) she has had amenorrhea for at least 12 months without hormone therapy, and 2) her LH and FSH blood levels are at menopausal levels or she has undergone bilateral oophorectomy, hysterectomy, etc.\n    * A woman aged 50 years or older is considered menopausal if\n\n      1. she has had amenorrhea for at least 12 months without hormone therapy, or\n      2. she became menopause after 1 year of amenorrhea following radiation or anticancer treatment, or\n      3. she has undergone bilateral oophorectomy, bilateral salpingectomy, hysterectomy, etc.\n13. Patient who is willing and able to comply with the protocol during the study, including treatments and tests such as scheduled visits, follow-up, etc.\n\nExclusion Criteria:\n\n1. Patient who received investigational product in another clinical study 2 weeks prior to participation in this clinical study\n2. Patient currently enrolled in another clinical study, other than the observational (non-interventional) study or follow-up period of an interventional clinical study.\n3. Concomitant chemotherapy, immunotherapy, biologic or hormonal therapy. Hormonal therapies not related to treatment for cancer (e.g., hormone replacement therapy) are allowed.\n4. Major surgical procedure within 28 days prior to zolbetuximab administration\n5. Distant metastasis including M1 lymph node\n6. Patient unable to take oral medication\n7. Gastric outlet obstruction and\u002For severe gastrointestinal hemorrhage that restricts diet without treatment\n8. Impaired intestinal absorption, including:\n\n   * Intestinal obstruction\n   * Chronic inflammatory bowel disease\n   * Operation history of extended bowel resection\n   * Gastric dumping syndrome\n9. Patient with a history of organ transplant\n10. Uncontrolled intercurrent disease including, but not limited to:\n\n    Ongoing or active infection, congestive heart failure with symptoms, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions accompanied with diarrhea, mental illness or social conditions that prevent compliance with study requirements, significantly increase the risk of adverse reactions, or interfere with written consent\n11. History of other primary malignancy, with the exception of:\n\n    * Patient who is at low risk of recurrence with disease-free status for at least 5 years prior to starting chemotherapy due to curative treatment\n    * Patient who is currently disease-free with cured skin cancer (except melanoma) or lentigo maligna\n    * Patient who is currently disease-free with cured in situ carcinoma\n12. Patient with a history of active congenital immunodeficiency\n13. Active infection, such as tuberculosis, confirmed by history, physical examination, radiographic findings, and TB testing per local standards, or HIV.\n\n    * Tuberculosis: History, physical examination, or radiological findings suggestive of active tuberculosis, or tuberculosis confirmed by tuberculosis testing per local standards (active TB is excluded and old TB is allowed)\n    * For HBV infection, the patient may be enrolled if appropriately treated with antiviral agents, etc.\n    * HIV\n\n      1. HIV Ag\u002FAb: If reactive, exclude\n      2. HIV Ag\u002FAb: If non-reactive, enroll\n14. Pregnant or lactating woman and man or woman of childbearing potential who is unwilling to use effective contraception (from the screening period to 90 days after the last dose of zolbetuximab)\n15. Individual with known allergy and hypersensitivity to the investigational product or its components",{"count":186,"type":20},57,[81,56],"Claudin 18.2 is a promising therapeutic target overexpressed on the surface of gastric cancer cells. The addition of zolbetuximab, the monoclonal antibody targeting Claudin 18.2 to chemotherapy in two recent Phase 3 studies prolonged survival outcomes, indicating that Claudin 18.2 is a valid target in gastric cancer. Asan Medical Center researchers conducted a study on Claudin 18.2 expression in patients with operable gastric cancer and defined moderate to strong claudin expression in more than 75% of tumor cells as Claudin 18.2 overexpression, which was observed in 46.5% of patients with stage I-III tumors. This suggests that zolbetuximab-based treatment may be possible in patients with LAGC.\n\nTherefore, The investigator designed a prospective, multicenter, open-label, Phase Ib\u002FII study to determine the efficacy and safety of zolbetuximab\u002FDOS as neoadjuvant chemotherapy in patients with LAGC.",[28,190],"Gastric (Stomach) Cancer",[192,193,61,62],"NEO-ADJUVANT","ADJUVANT","2025-07-24",{"date":196,"type":36},"2025-07-28",{"date":198,"type":36},"2025-04-04",{"date":40,"type":20},{"name":70,"class":43},2,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":54,"phases":213,"briefSummary":214,"conditions":215,"keywords":229,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":201},"100518299","phase-2-total-neoadjuvant-flot-chemotherapy-in-locally-advanced-gastric-and-gastroesophageal-junction-cancer-100518299","NCT06028737","Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer","Total Neoadjuvant Chemotherapy With 5-fluoruracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial, Phase 2\u002F3","OCTASUR","Inclusion Criteria:\n\n* Tumor spread according to TNM: ≥cT3 and\u002For ≥cN0 and M0 (except of invasion of the common hepatic artery, celiac trunk, proximal part of the splenic artery, aorta, head of the pancreas);\n* Performance status by Eastern Cooperative Oncology Group (ECOG): 0 - 1;\n* Histologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert type 2\u002F3) adenocarcinoma.\n* Differentiation grade: G0 - G4;\n* Tumor localization: cardio-esophageal junction (Siewert 2, 3), cardiac part of the stomach, body of the stomach, antral part of the stomach, pyloric part of the stomach;\n* Tumor extension: esophagus, diaphragm, liver, body and tail of the pancreas, anterior abdominal wall, small and large intestine, distal part of the splenic artery, spleen;\n* Patient agrees to participate in this biomedical study.\n\nExclusion Criteria:\n\n* Presence of another oncological disease at a different site if less than 5 years have passed since radical treatment.\n* Comorbidities or patient conditions that preclude the administration of chemotherapy.","80 Years",{"count":212,"type":20},150,[56,157],"The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery:\n\n1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery.\n2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.",[27,216,217,218,219,220,221,28,222,223,224,225,133,226,227,228],"Stomach Cancer","GastroEsophageal Cancer","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Advanced Gastric Adenocarcinoma","Gastric Neoplasm","Gastrointestinal Cancer","Advanced Gastroesophageal Junction Adenocarcinoma","Advanced Gastric Carcinoma","Chemotherapy","Gastrectomy for Gastric Cancer","Gastric Resection","Gastric (Cardia, Body) Cancer",[230,231,232,133,233,234,235,236,108],"Total neoadjuvant chemotherapy","FLOT","Fluoruracil","Perioperative chemotherapy","Docetaxel","Leucovorin","Gastric resection","2025-04-30",{"date":239,"type":36},"2025-05-06",{"date":241,"type":36},"2025-03-25",{"date":243,"type":20},"2032-12-31",{"name":245,"class":43},"Ukrainian Society of Clinical Oncology",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":255,"conditions":256,"keywords":257,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":44},"100587058","gastric-cancer-textbook-oncological-outcome-and-tumor-board-performance-100587058","NCT06923449","Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance","Gastric Cancer' Textbook Oncological Outcome and Tumor Board Performance - The Experience of a High-volume Italian University Hospital","GaC-TOP","Inclusion Criteria:\n\n* pathology-confirmed diagnosis of gastric adenocarcinoma\n* age 18 years or older\n* surgical candidates with curative intent\n\nExclusion Criteria:\n\n* Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD)\n* previous EMR or ESD (salvage surgery)\n* histologies other than adenocarcinoma (no squamous cell carcinomas, GISTs, sarcomas, lymphomas, etc)\n* unsufficient staging (unclear clinical stage at diagnosis)\n* emergency presentation (obstrucetd, significantly bleeding, perforated gastric cancer)\n* synchronous tumors affecting survival\n* pregnant patients\n* age \\\u003C18years",{"count":155,"type":20},"The goal of this observational, no-profit, spontaneous, retrospective, monocentric study is to compare surgical and oncologic outcomes in patients affected by gastric cancer before and after the institution of the Tumor Board, a multidisciplinary weekly case discussion. The main question it aims to answer is whether the Textbook Outcome (TO) and Textbook Oncological Outcome (TOO) of patients with non-early, non-metastatic gastric cancer undergoing surgical treatment with curative intent have improved before (from January 2018 to November 2019) and after (from December 2019 onwards) the establishment of the Multidisciplinary Tumor Board (MTB) at Fondazione Policlinico Gemelli (FPG).",[28],[27,258,259,260],"Multidisciplinary Tumor Board","Textbook Outcome","Textbook Oncological Outcome",{"date":262,"type":36},"2025-04-11",{"date":264,"type":36},"2024-05-16",{"date":266,"type":20},"2025-06-30",{"name":268,"class":43},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":44},"100576965","prediction-of-drug-response-in-gastric-cancer-based-on-3d-bioprinting-100576965","NCT06792149","Prediction of Drug Response in Gastric Cancer Based on 3D Bioprinting","Research on the Value of Predicting Drug Efficacy Based on 3D Bioprinting for Constructing In Vitro Gastric Cancer Models","Inclusion Criteria:\n\n* More than 18 years old\n* Patients previously diagnosed with gastric cancer or confirmed by pathology as having gastric cancer postoperatively.\n* Patients who have undergone preoperative imaging examinations, including plain and contrast-enhanced CT scans of the chest, abdomen, and pelvis, as well as gastric MRI for tumor staging, and who are planned for preoperative (neo)adjuvant therapy after multidisciplinary team (MDT) discussion; patients with advanced gastric cancer who are confirmed by postoperative pathology to require (neo)adjuvant therapy.\n* The patient or their family members are able to comprehend the research protocol and are willing to participate in this study, providing written informed consent.\n\nExclusion Criteria:\n\n* History of other malignancies or serious medical conditions\n* Inability to provide independent informed consent",{"count":277,"type":20},60,"The therapeutic regimens for adjuvant and neoadjuvant chemotherapy in gastric cancer (GC) predominantly hinge on clinical experience. Consequently, there is an imperative need for preclinical models to facilitate the guidance of individualized medicine. The investigators plan to establish three-dimensional (3D) bioprinted GC models derived from surgically resected tumor tissues of GC patients. These in vitro 3D models will be subjected to treatment with the identical chemotherapy drugs administered to the corresponding patients from whom the models are sourced. The sensitivity of the chemotherapy drugs will be assayed within the in vitro models, and the actual response to chemotherapy in patients will be meticulously evaluated. This observational study aims to substantiate the potential utility of 3D bioprinted tumor models in prognosticating the response to chemotherapy in GC.",[104],"2025-01-19",{"date":282,"type":36},"2025-01-24",{"date":284,"type":36},"2023-10-01",{"date":286,"type":20},"2025-12-31",{"name":288,"class":43},"Peking Union Medical College Hospital",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":296,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":54,"phases":299,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":305,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":44},"100576188","phase-2-use-of-pyrvinium-to-reverse-stomach-precancerous-conditions-100576188","NCT06782048","Use of Pyrvinium to Reverse Stomach Precancerous Conditions","Pyrvinium for Reversal of Precancerous Metaplasia and Dysplasia in the Stomach","Inclusion Criteria:\n\n* The subject is at least 21 years of age.\n* The subject has histologically proven extensive\u002Fmarked intestinal metaplasia and\u002For dysplasia.\n* The subject is willing and able to provide signed and dated patient informed consent form indicating that he\u002Fshe has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* The subject has an active gastric cancer diagnosis.\n* The subject is pregnant.\n* The subject has a high-risk of bleeding complications due to anticoagulants or underlying medical condition such as bleeding disorders in whom biopsies are contraindicated.\n* The subject has impaired renal function.\n* The subject has impaired hepatic function.\n* The subject has fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.\n* The subject has chronic bowel disease.\n* The subject has any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgement of the investigator would make the subject unsuitable for entry into the study.\n* The subject is unwilling or unable to provide signed informed consent.","21 Years",{"count":298,"type":20},50,[56],"This study is carried out to find out if a drug called pyrvinium is able to convert pre-cancerous tissue in the stomach back to healthy tissue, to lower the chances of stomach cancer. Pyrvinium is a drug that has been used for a long time to treat pinworms in children and its anti-cancer properties are currently under investigation. Tests in animals have shown that pyrvinium made unhealthy tissue healthier and stopped some cells from growing in a bad way. Based on preclinical studies, the investigators hypothesise that the proportion of samples with pre-cancerous tissue in the stomach would decrease by 50% after exposure to pyrvinium at the 6-week timepoint, with anticipated durability of the response at the one-year follow-up.",[104],[27,28,303,304],"Intestinal Metaplasia","Pyrvinium","NOT_YET_RECRUITING","2025-01-13",{"date":308,"type":36},"2025-01-17",{"date":310,"type":20},"2025-08",{"date":312,"type":20},"2029-12",{"name":314,"class":43},"National University Hospital, Singapore",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":321,"sex":16,"minAge":17,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":305,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":4},"100501671","exploring-the-difference-between-gastric-cardia-cancer-and-non-cardia-gastric-cancer-based-on-multiomics-100501671","NCT05812287","Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics","Inclusion Criteria:\n\n* Study population signing informed consent form\n* Age: 18-75 years old\n* The study population must underwent endoscopic examination and was confirmed by pathological diagnosis as gastric cancer: including high-level intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.\n\nExclusion Criteria:\n\n* Those who have undergone gastrointestinal surgery within the past 1 year; Patients who have undergone neoadjuvant chemotherapy and have developed tumors in the residual stomach after previous partial gastrectomy.\n* Those who have used proton pump inhibitors, antibiotics, probiotics, and prebiotics daily within the past month, and those who have recently received hormone therapy.\n* People with infectious diseases and other digestive system diseases that interfere with the experimental results, such as inflammatory bowel disease, irritable bowel syndrome, etc.",true,"75 Years",{"count":324,"type":20},120,"This is an observational study with a case control design. This study included patients with gastric cancer confirmed by pathological diagnosis of gastric tissue, and matched the control population according to age, gender, etc. In this study, researchers collected clinical information and multiple biological samples such as saliva, serum, and feces from the study subjects. We combined 16S rRNA sequencing and metabolomics to explore the differences in microbial and metabolic characteristics between gastric cardia cancer and non-cardia gastric cancer for early screening of gastric cancer.",[28],"2023-11-15",{"date":329,"type":36},"2023-11-18",{"date":331,"type":20},"2023-12",{"date":333,"type":20},"2028-12",{"name":335,"class":43},"Qilu Hospital of Shandong University",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":322,"enrollmentInfo":344,"targetDuration":4,"studyType":54,"phases":346,"briefSummary":347,"conditions":348,"keywords":356,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":44},"100525435","phase-2-radiotherapy--chemoimmunotherapy-followed-by-surgery-in-patients-with-limited-metastatic-gastric-or-gej-cancer-100525435","NCT06121700","Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer","Radiotherapy, Chemotherapy and Anti-PD-1 Immunotherapy Followed by Surgical Resection in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Single Arm, Phase II Trial","Miracle-G","Inclusion Criteria:\n\n1. Histopathologically confirmed adenocarcinoma of stomach (G) or gastroesophageal junction (GEJ) (excluding Siewert type I).\n2. Limited metastatic status of disease.\n3. At least one evaluable lesion in CT\u002FMRI according to RESIST 1.1 is required.\n4. The status of HER2 is clear.\n5. pMMR\u002FMSS confirmed by immunohistochemistry or gene test.\n6. Male or female. Patient age ≥ 18 years and ≤ 75 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n8. Physical state or organ function can tolerate the planned treatment of the study protocol, including systematic chemotherapy, immunotherapy with anti-PD-1 monoclonal antibody (mAb), primary lesion radiotherapy, metastatic lesion radiotherapy, and surgical resection of primary and\u002For metastatic lesions.\n9. No previous surgery or antitumor therapies, including chemotherapy, radiotherapy, or immunotherapy, were administered.\n10. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; platelet count ≥ 100×109\u002FL; hemoglobin level ≥ 90 g\u002FL.\n11. Adequate hepatic function: total bilirubin ≤ 1.5×upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \\\u003C 2.5 × ULN in the absence of liver metastases, or \\\u003C 5 × ULN in case of liver metastases; ALP ≤ 2.5×ULN; ALB ≥ 30 g\u002FL.\n12. Adequate renal function: serum creatinine ≤ 1.5×ULN; creatinine clearance rate ≥ 60 ml\u002Fmin.\n13. Adequate coagulation function: INR\u002FPT ≤ 1.5×ULN; APTT ≤ 1.5×ULN.\n14. TSH is within the normal range; if TSH is out of the normal range, FT3 and FT4 should be investigated. If the test results of FT3\u002FFT4 cannot be obtained, T3 and T4 can be accepted. 13. If the level of T3\u002FT4 is normal, the patients can be selected.\n15. Urine test: urine protein\\\u003C2+; if the urine protein≥2+, the 24-hour urine protein quantification must be≤1g.\n16. There is no serious concomitant disease, and the patient's life expectancy is more than 6 months.\n17. Patients agree to sign written informed consent before recruitment.\n18. Patients are willing and able to follow the protocol during the study, including receiving treatment and scheduled follow-up and examination.\n19. Patients are willing to provide samples of blood and tissue.\n20. Female patients should not be pregnant or breast feeding.\n21. Female patients agree to take contraceptive measures during treatment and within 120 days after the last dose of anti-PD-1 mAb or 180 days after the last use of chemotherapy or radiotherapy.\n\nDefinition of the limited metastatic disease:\n\n1. Retroperitoneal lymph node metastases (RPLM) only or at maximum one organ involved with or without RPLM.\n2. There is no peritoneal seeding on diagnostic laparoscopy (P0).\n3. The definition of RPLM includes but is not limited to para-aortal, intra-aorto-caval, parapancreatic or mesenteric lymph nodes. If the duodenum is invaded, retropancreatic nodes are not regarded as M1.\n4. The definition of single organ metastasis in the study is as follows: a) Liver: maximum of 5 metastatic lesions that are potentially resectable and the metastases should be limited to one lobe and not involve important blood vessels or bile ducts. b) Lung: unilateral involvement, potentially resectable. c) Ovary: uni- or bilateral Krukenberg tumors in the absence of macroscopic peritoneal carcinomatosis. d) Adrenal gland: uni- or bilateral metastases. e) Extra-abdominal lymph node metastases, such as supraclavicular or cervical lymph node involvement. f) Bone: localized bone involvement (defined as being within one radiation field).\n5. Other metastatic disease locations are considered, limited by the investigator and confirmed by the multidisciplinary team (MDT).\n\nExclusion Criteria:\n\n1. Patients who have previously received surgery, chemotherapy, radiotherapy or immunotherapy for gastric cancer.\n2. Patients have a history of cancer in the five years before enrollment except for squamous or basal cell carcinoma of the skin that was effectively treated and superficial bladder cancer, cervical carcinoma in situ and breast cancer in situ that was treated by operation.\n3. Pregnant or lactating females or females planning to become pregnant or lactating. Women of childbearing age with a positive pregnancy test or without a pregnancy test in the baseline period. Menopausal women must have stopped menstruating for at least 12 months before being considered to have no chance of pregnancy.\n4. Patients who had sexual activity (with the possibility of childbirth) and were unwilling to use contraception during the study period.\n5. Patients with a history of allergies to any drugs that may be used in this study, including chemotherapy drugs.\n6. History of allogeneic stem cell transplantation or organ transplantation.\n7. Vaccinated with live vaccine within 28 days before recruitment.\n8. Immunotherapy (interleukin, interferon, thymine) or other experimental treatment was given 28 days before enrollment.\n9. History of anti-PD-1, PD-L1, PD-L2 or any other specific T-cell costimulation or checkpoint pathway targeted therapy.\n10. History of using steroids (dose \\> 10 mg\u002Fd prednisone) or other systemic immunosuppressive therapy within 14 days before recruitment, except for patients treated with the following regimen: steroids used for hormone replacement (dose \\> 10 mg\u002Fd prednisone); local application of steroids with little systemic absorption; short-term (≤ 7 days) use of steroids to prevent allergy or vomiting.\n11. Patients with weight loss of more than 20% within 2 months before recruitment.\n12. Uncontrolled systemic diseases, including diabetes, hypertension, etc.\n13. Uncontrollable pleural effusion, pericardial effusion, or ascites occurred within two weeks before recruitment.\n14. Failure of important organs (heart, lung, liver, kidney, etc.).\n15. Moderate or severe renal injury \\[creatinine clearance ≤ 50 ml\u002Fmin (according to Cockcroft \\& Gault equation)\\], or SCR \\> ULN.\n16. Dipyrimidine dehydrogenase (DPD) deficiency.\n17. Patients with central nervous system (CNS) disorders or tumors, including brain metastases, peripheral nervous system disorders or psychiatric diseases.\n18. Cerebrovascular accidents occurred within 6 months before recruitment.\n19. Patients with peripheral neuropathy of NCI-CTCAE grade 1, except for those with disappearance of the deep tendon reflex.\n20. Patients with a known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, congestive heart failure, cardiac infarction or cardiac insufficiency within 6 months prior to study recruitment.\n21. Pulmonary embolism occurred within 28 days before enrollment.\n22. Patients who had the following history of pulmonary diseases: interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, or acute lung disease.\n23. Patients with gastrointestinal bleeding or a high risk of bleeding within the first 2 weeks of enrollment.\n24. Patients who experienced gastrointestinal perforation or fistula within 6 months prior to enrollment.\n25. Upper gastrointestinal obstruction, dysfunction or malabsorption syndrome may affect the absorption of oral chemotherapy drugs.\n26. Patients who cannot swallow or take medication orally.\n27. Patients with a history of active autoimmune disease or refractory autoimmune disease.\n28. Severe chronic or active infections requiring systemic antibiotics, antifungal or antiviral therapy, including tuberculosis and AIDS.\n29. Known history of human immunodeficiency virus (HIV) infection.\n30. Patients with untreated chronic hepatitis B or HBV-DNA exceeding 500 IU\u002Fml or HCV-RNA positive.\n31. Alcohol\u002Fdrug abuse and medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the evaluation of the study results.",{"count":345,"type":20},55,[56],"The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients.\n\nParticipants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+\u002FISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.",[349,28,350,351,352,353,354,219,355],"Adenocarcinoma","Gastroesophageal-junction Cancer","Oligometastatic Disease","Metastatic Cancer","Metastatic Gastric Cancer","Adenocarcinoma of the Stomach","Metastatic Adenocarcinoma",[357,358,359,360,361,362,363,364],"gastric cancer","GEJ Cancer","oligometastasis","limited metastatic","hypofractionated radiotherapy","immunotherapy","gastrectomy","metastasectomy","2023-11-07",{"date":367,"type":36},"2023-11-08",{"date":369,"type":36},"2023-01-01",{"date":40,"type":20},{"name":372,"class":43},"Fudan University",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":54,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":44},"100488476","phase-1-capeox-regimen-combined-with-sintilimab-and-bevacizumab-for-gastric-cancer-100488476","NCT05640609","Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer","A Phase Ib\u002FII Trial of Capeox Regimen Combined With Sintilimab and Bevacizumab in First-line Treatment for Recurrent or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Histological or cytological diagnosis confirmed adenocarcinoma of stomach and gastroesophageal junction (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma)\n2. Imaging and surgical evaluation of unresectable recurrent or metastatic patients\n3. The expected survival time was more than 3 months\n4. The age is between 18 and 70 years old, both male and female\n5. No systematic treatment has been given to patients with advanced or metastatic gastric and esophagogastric junction adenocarcinoma.If the patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy and chemotherapy), the last treatment must be completed at least 6 months before randomization, and there is no recurrence or disease progression at the time of treatment.Palliative radiotherapy was allowed, but it must be completed at least 2 weeks before the first study treatment.Subjects were allowed to receive anti-tumor traditional Chinese medicine preparations in the past, but they must be discontinued at least 2 weeks before randomization\n6. Eastern Cooperative Oncology Group(ECoG) - 1 physical status\n7. At least one lesion can be evaluated according to RECIST 1.1 criteria\n8. It can provide pathological tissues or fresh pathological tissues that are filed within 6 months after the signature of informed consent for screening, and can obtain the test results. For the slices filed within 6 months before randomization, it should be confirmed that no systematic treatment (including adjuvant \u002F neoadjuvant therapy) has been received after obtaining the samples\n9. The function of the main organs is normal, that is to say, it meets the following standards:\n\n   1. Blood routine examination (no blood transfusion within 14 days before screening)\n   2. Hemoglobin ≥ 90 g \u002F L;\n   3. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL;\n   4. Platelet count ≥ 75×109\u002FL; Blood biochemical test (albumin was not used within 14 days before screening)\n   5. Albumin ≥ 28 g \u002F L;\n   6. Total bilirubin ≤ 1.5×Upper limit of normal value (ULN);\n   7. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3×ULN; If there is liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 5×ULN\n   8. Creatinine ≤ 1.5×ULN;Coagulation function:\n   9. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN;\n   10. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN\n10. For sections filed in the first 6 months of randomization, it should be confirmed that no systematic treatment (including adjuvant \u002F neoadjuvant therapy) has been received since sample acquisition\n11. Acute toxicity caused by previous anti-tumor treatment or surgery was relieved to grade 0-1 (according to ncictcae 5.0) or to the level specified in the inclusion \u002F exclusion criteria\n12. Female subjects of childbearing age were required to conduct a serum pregnancy test within 3 days before the start of the study, and the results were negative, and they were willing to use a medically recognized high-efficiency contraceptive method (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study drug;For male subjects whose partners are women of childbearing age, they should be sterilized by surgery or agree to use effective contraceptive methods during the study and within 3 months after the last study administration\n13. With my consent and signed the letter of understanding, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedures\n\nExclusion Criteria:\n\n1. HER2 + (or HER2 +) is known to be positive\n2. Gastric cancer known as squamous cell carcinoma, undifferentiated or other tissue types, or adenocarcinoma mixed with other tissue types\n3. There are uncontrolled or symptomatic active central nervous system (CNS) metastases, which can be characterized by clinical symptoms, brain edema, spinal cord compression, cancer metastasis, malignant meningitis, leptomeningeal disease, and \u002F or progressive growth.Patients with CNS metastases can be enrolled in the study if they are adequately treated and their psychiatric symptoms can return to baseline level at least 2 weeks before randomization (except for residual signs or symptoms related to CNS treatment).In addition, subjects were required to discontinue corticosteroids or receive prednisone (or equivalent other corticosteroids) at least 2 weeks before randomization, or to receive a stable or gradually reduced dose of prednisone (or equivalent) at least 2 weeks before randomization\n4. There were hydrothorax and ascites which could not be controlled by puncture and drainage within 14 days before the random;Pericardial effusion with clinical symptoms or moderate or above\n5. The weight of the subjects decreased by more than 20% in the first two months of randomization\n6. The following treatments or drugs were received before randomization: a) major surgery was performed within 28 days before randomization (tissue biopsy and peripherally inserted central catheter operation peripherally inserted central venous catheter （PICC） for diagnosis are allowed; b) immunosuppressive drugs were used within 7 days before randomization,Does not include nasal and inhaled corticosteroids or physiological doses of systemic hormones (i.e. no more than 10 mg \u002F D of nisone or other corticosteroids with equivalent physiologic doses);c) Live attenuated vaccine was administered within 28 days before randomization or within 60 days after the end of drug treatment;d) Antineoplastic therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy or tumor embolization) within 28 days before randomization\n7. Any other malignant tumor was diagnosed within 3 years before entering the study, except basal cell carcinoma of skin or squamous or superficial bladder cancer, carcinoma in situ of cervix, intraductal carcinoma of breast and papillary thyroid carcinoma that can be treated locally and cured.\n8. There is any active, known or suspected autoimmune disease.Subjects who were in a stable state and did not need systemic immunosuppressive therapy were allowed to be included, such as type I diabetes mellitus, hypothyroid diabetes mellitus requiring hormone replacement therapy only, and skin diseases without systemic treatment (e.g., vitiligo, psoriasis and alopecia)\n9. Previously received anti-PD-1 \u002F PD-L1 antibody, anti-CTLA-4 antibody or other drugs acting on T-cell co stimulation or examination cell co stimulation or checkpoint pathway\n10. There were significant bleeding symptoms or bleeding tendency in 3 months before random;Gastrointestinal perforation and \u002F or gastrointestinal fistula occurred within 6 months before randomization;Arteriovenous thrombosis events occurred in the first 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc\n11. Major vascular disease (e.g. aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis) within 6 months before the start of study treatment\n12. Severe, unhealed or dehiscent wounds and active ulcers or untreated fractures\n13. There were peripheral neuropathy \\> 1 grade\n14. If the symptoms of ileus (ileus) at the beginning of the study (with or without complete parenteral nutrition treatment) and symptoms of ileus were resolved at the time of initial diagnosis or complete parenteral nutrition treatment, or if the patient did not have the symptoms of ileus at the time of initial diagnosis \u002F treatment, or had not received complete parenteral nutrition treatment,Patients may be admitted to the study\n15. Interstitial lung disease, non infectious inflammation or uncontrollable systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia, etc.)\n16. Known allergy to the study drug or any of its excipients, or severe allergic reactions to other monoclonal antibodies\n17. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)\n18. Untreated active hepatitis B was defined as HBV-DNA ≥ 500 IU \u002F ml;Hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method;Or combined with hepatitis B and C co infection\n19. In the first 6 months, the following conditions occurred: myocardial infarction, severe \u002F unstable angina pectoris, New York Heart Association （NYHA ）grade 2 or above cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure\n20. Hypertension was poorly controlled by drug therapy (systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg)\n21. Systemic use of antibiotics for more than 7 days in 4 weeks before randomization, or fever of unknown origin \\> 38.5 ° C during screening period \u002F before first administration (fever due to tumor can be included in the group according to the judgment of the researcher)\n22. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n23. Participated in any other drug clinical study within 4 weeks before randomization, or no more than 5 half-life from the last study\n24. A history of psychotropic substance abuse or abuse is known\n25. The presence of other laboratory abnormalities with severe physical or mental illness may increase the risk of participating in the study, or interfere with the results of the study and patients considered unsuitable for the study","70 Years",{"count":186,"type":20},[81,56],"The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. This is a one-arm, open and prospective phase II clinical study. Recruit patients who have been diagnosed with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction and have not received systematic treatment.",[28],"2023-05-12",{"date":387,"type":36},"2023-05-16",{"date":389,"type":36},"2023-03-10",{"date":391,"type":20},"2026-11-01",{"name":393,"class":43},"West China Hospital",{"id":395,"slug":396,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":401,"maxAge":210,"enrollmentInfo":402,"targetDuration":4,"studyType":54,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":305,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":4},"100413055","laparoscopic-vs-open-distal-gastrectomy-after-neoadjuvant-chemotherapy-100413055","NCT04658589","Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy","A Multicenter Prospective Phase II Comparative Study of Laparoscopic Versus Open Distal Gastrectomy After Neoadjuvant Chemotherapy for the Treatment of Locally Advanced Gastric Cancer Patients","Inclusion Criteria:\n\n1. Patients who voluntarily expressed their consent to participate in this trial by signing a written 'Subject Consent Form.'\n2. Patients whose gastric adenocarcinoma located in the middle or lower part of the stomach is histologically confirmed and deemed possible to perform a radical distal gastrectomy surgery.\n3. Patients who come under T2\u002FN(+)M0, T3\\~4a\u002FN(- or +) M0 according to the 8th edition of the TNM classification.\n\nExclusion Criteria:\n\n* Methodologies\n\n  1. Patients less than 20 years old or older than 80 years old\n  2. Eastern Cooperative Oncology Group(ECOG) ≥ 2\n  3. Patients with a surgery experience due to a neoplasm in the stomach.\n  4. Patients with complications due to gastric cancer (acute hemorrhage, gastric outlet obstruction or perforation)\n  5. Patients with distant metastases (M1) including distant lymph nodes (Retropancreatic, para-aortic, periportal, retroperitoneal, or mesenteric lymph nodes)\n  6. Patients without distant metastases but who are, according to a surgeon's judgment, unqualified for radical gastrectomy because of invasions to adjacent organs (T4b).\n  7. In the case of localized conglomerated metastatic lymph nodes\n  8. Patients who received surgery or radiation therapy for a primary cancer developed in another organ or those with active\u002Fsynchronous double cancer in recent 5 years.\n  9. Patients who participated in another clinical trial or was administered with a different investigational drug in 30 days prior to randomization.\n  10. Patients who had any of the following in 6 months before the trial recruitment: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.\n  11. Patients with a previous experience of uncontrolled seizure, central nervous system or psychological disorders whose conditions are clinically significant to the extent that they are unable to express consent to participate in the trial and oral drug administration is not possible.\n  12. Patients with uncontrolled active infection or sepsis.\n  13. Patients who had deep vein thrombosis in recent 4 weeks before the beginning of the trial recruitment.\n  14. Patients with serious acute or chronic disease that can degrade the patient's ability to participate in the trial or impede the interpretation of the trial results.\n  15. Pregnant or breast-feeding patients. Fertile female patients who are positive in pregnancy test.\n\n      Drug Administration for Neoadjuvant Chemotherapy\n  16. Inadequate functions of marrow or organs:\n\n      I. Absolute Neutrophil Count (ANC) \\\u003C 1.5 x 109\u002FL II. Platelet (PLT) \\\u003C 100 x 109\u002FL III. Hemoglobin (Hb) ≤ 9 g\u002FdL IV. AST\\> 2.5 x ULN, ALT\\> 2.5 x ULN V. ALP \\> 2.5 x ULN VI. Total Bilirubin (T. Bil) \\> 1.5 x ULN VII. Serum creatinine (Cr) \\> 1.5 x ULN\n  17. Patients who have peripheral neuropathy with clinical signs of Grade≥2 (NCI CTCAE v4.03) or with absence of deep tension reflex (DTR).\n  18. Patients with hypersensitivity history of the investigational drug (5-FU, Oxaliplatin, Docetaxel).\n  19. Patients who are on treatment with warfarin or coumarin anticoagulants.\n  20. Patients who are on immunosuppressive therapy.\n  21. Patients who are receiving co-medication with Cytochrome P450 2A6 inducer, inhibitor, and substrate.","20 Years",{"count":403,"type":20},238,[129],"The study was designed as single-country, multi-center, open-labelled, randomized (1:1), phase II trial.\n\n238 patients with medically and technically operable advanced gastric adenocarcinoma in middle or distal 1\u002F3 of stomach are enrolled and randomly assigned to laparoscopic gastrectomy group and open gastrectomy group. 4 cycles of mFLOT chemotherapy will be conducted before and after gastrectomy.\n\nThe primary objective of this study is comparison of D2 lymph node dissection compliance rate between open surgery group and laparoscopic surgery group after neoadjuvant chemotherapy.",[28],"2020-12-07",{"date":409,"type":36},"2020-12-08",{"date":411,"type":20},"2021-01",{"date":90,"type":20},{"name":414,"class":43},"Chonnam National University Hospital"]