[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-gastric-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,44,77,102,158,189,212,237,261,292,327,350],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100453329","phase-4-pharmacokinetic-study-of-skeletal-muscle-area-based-paclitaxel-infusion-in-patients-with-cancer-100453329",false,"NCT05183126","Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer","Phase IV Single-arm Pharmacokinetic Study of Skeletal Muscle Area-based Paclitaxel Infusion in Patients With Cancer","Inclusion Criteria:\n\n* Planned paclitaxel 80 mg\u002Fm\\^2, 1-hour infusion\n* Evaluable computed tomography (CT) scan, positron emission tomography computed tomography (PET-CT) scan, or MRI scan (e.g. scan of the chest, abdomen, or pelvis for any indication w\u002Fin 1 year)\n* Female\n* ≥ 18 years old\n* Adequate organ function to receive paclitaxel treatment as defined in the protocol\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Concomitant administration of any moderate or strong inducer or inhibitor of CYP2C8, including rifampin or clopidogrel.\n* History of hypersensitivity reaction to paclitaxel or any components of paclitaxel (e.g., Cremophor EL) that precludes continued treatment with standard dose and infusion length\n* Pregnant or nursing\n* Receiving any other dose (i.e., not 80 mg\u002Fm2) or infusion rate (i.e., not 60 minute infusion) either due to toxicity during a previous cycle or any other reason","FEMALE","18 Years",{"count":19,"type":20},22,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The primary objective of this pharmacokinetics study is to compare the maximum concentration level of paclitaxel in patients with low\u002Fsarcopenic skeletal muscle area (SMA), at the end of a 2-3 hour paclitaxel infusion, to the maximum level in patients with normal SMA at the end of a standard 1-hour infusion with the goal of determining whether lengthening the infusion in patients with low\u002Fsarcopenic SMA normalizes the levels to those of patients with normal SMA.",[26,27,28],"Breast Cancer","Metastatic Gastric Cancer","Esophageal Cancer",[30],"pharmacokinetics","RECRUITING","2026-07-01",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2022-03-28",{"date":39,"type":20},"2026-11",{"name":41,"class":42},"University of Michigan Rogel Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100623150","phase-2-symbiotic-gi-16-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-gastroesophageal-cancer-100623150","NCT07392892","Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer","A PHASE 2\u002F3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA","Inclusion Criteria:\n\n* Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.\n* Evidence of locally advanced or metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* No prior systemic therapy for advanced or metastatic disease.\n* Adequate hepatic, liver, and renal function\n* HER-2 negative status based on local testing\n* PD-L1 positive status based on local testing\n\nExclusion Criteria:\n\n* Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis","ALL",{"count":53,"type":20},840,[55,56],"PHASE2","PHASE3","This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\nBe 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests.\n\nThe study has two parts:\n\n* In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it.\n* In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better.\n\nThe treatment will be given in repeated time periods called cycles.",[59,27,60,61],"Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction , or Esophageal Adenocarcinoma","Gastroesophageal Junction Cancer","Esophageal Adenocarcinoma",[63,64,65],"gastric cancer","gastroesophageal junction cancer","esophageal adenocarcinoma","2026-06-10",{"date":68,"type":35},"2026-06-12",{"date":70,"type":35},"2026-05-14",{"date":72,"type":20},"2032-07-21",{"name":74,"class":75},"Pfizer","INDUSTRY",71,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100637801","phase-1-a-phase-i-interventional-open-label-non-randomized-dose-escalation-trial-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-immunogenicity-and-preliminary-anti-tumor-activity-of-autologous-p95her2car-tech2me-t-cells-in-patients-with-selected-advanced-cancers-100637801","NCT07593820","A Phase I Interventional Open-label, Non-randomized Dose-escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients With Selected Advanced Cancers.","Catherine","Inclusion Criteria:\n\n1. Patients must understand and voluntarily sign an informed consent document before any study-related assessments\u002Fprocedures being conducted.\n2. Age ≥ 18 and years at the time of signing the ICF\n3. Patients must be able and willing to comply with the study visit schedule and protocol requirements.\n4. Patients must have a clinical performance of Eastern Cooperative Oncology Group 0 or 1.\n5. Life expectancy ≥12 weeks.\n6. Patients must have histologically or cytologically proven unresectable or metastatic tumors. The disease must be refractory to standard therapy or in the first line if they are unable to receive standard therapy or no standard therapy exists for a particular disease.\n\n   a) Select tumor types: breast, gastric, and endometrial tumors. Other selected solid tumors may be included per investigator discretion if the potential benefit is considered based on the literature updates in HER2\u002Fp95HER2 expression.\n7. Positivity for HER2 expression according to international society guidelines (score in a ISO-certified clinical or equivalent laboratory). To meet study entry eligibility, tumors are required to have at least an intensity score 3+ for HER2 staining following the manufacturer's recommendations\n8. Measurable disease by the RECIST v. 1.1 criteria (See Section 7.2 for details). Note: Lesions previously irradiated should not be selected as target lesions unless there has been demonstrated progression in those lesions;\n9. Patients are considered medically fit enough to undergo all study procedures and interventions and adequate hematological, renal, and hepatic functions defined by:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL.\n   2. An absolute neutrophil count ≥ 1x10E9\u002FL without the support of filgrastim\n   3. Platelets ≥ 100 x10E9\u002FL.\n   4. PT and APTT ≤ 1.5x ULN (unless receiving therapeutic anticoagulation). Note: Subjects receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.\n   5. AST or ALT ≤ 3 x ULN. Patients with liver metastases must have AST and ALT ≤ 5.0 x ULN.\n   6. Total bilirubin \\\u003C 2 mg\u002FdL. Patients with Gilbert's Syndrome must have a total bilirubin ≤ 3.0 mg\u002FdL.\n   7. Serum creatinine \\\u003C 1.5 mg\u002FdL or measured creatinine clearance ≥ 50 ml\u002Fmin calculated using the Cockcroft-Gault glomerular filtration rate estimation: (140 - age) × (weight in kg) × (0.85 if female)\u002F72 × (serum creatinine in mg\u002FdL).\n10. Patients must be seronegative for HIV antibody.\n11. Patients must be seronegative for active hepatitis B (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test), and seronegative for hepatitis C antibody. Patients with a history of hepatitis B virus (HBV) infection and having a negative HBsAg test and a positive antibody to hepatitis B surface antigen (HBsAg) are eligible. Patients with the hepatitis C antibody test positive are eligible only if tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n12. Patients must have blood tests results negative for active tuberculosis, syphilis, herpes simplex virus, cytomegalovirus, HTLV or Epstein-Barr virus infection.\n13. Patients with documented LVEF of ≥ 50%.\n14. Patients with documented FEV1, FVC, and DLCO ≥ 50% tested by a pulmonary function test.\n15. Patients who are of childbearing potential (postmenarcheal who has not reached a postmenopausal state and has not undergone surgical sterilization) or have partners of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 12 months after the infusion of the p95HER2.CAR-TECH2Me product .\n16. Female participants: a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Women of non-childbearing potential (WONCBP).\n    2. Women of childbearing potential (WOCBP), who:\n\n    i) Agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C1% per year from screening until 12 months after the infusion of the p95HER2.CAR-TECH2Me product. Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal occlusion, male sterilization, and copper intrauterine devices.\n\n    ii) Have a negative pregnancy test (blood) within one week before the first study treatment administration (applicable to premenopausal women and women 2 years after the start of menopause (menopause is defined as amenorrhea for \\\u003C 2 years).\n17. Male Participants: during the treatment period and for at least 6 months after the last dose of study treatment, agreement to:\n\n    1. Remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom or a contraceptive method that result in a failure rate of \\\u003C1% per year, with partners who are WOCBP.\n    2. Refrain from donating sperm during the study.\n    3. Inform if his partner gets pregnant during this time.\n18. Adequate expanding p95HER2.CAR-TECH2Me cells as defined by the T cell production manual before preparative lymphodepleting chemotherapy infusion (available autologous transduced T lymphocytes with 15% or more expression of p95HER2.CAR-TECH2Me as determined by flow-cytometry and killing of p95HER2-positive targets 20 % or greater in cytotoxicity assay.)\n19. Any toxicity related to prior systemic therapy must have recovered to grade 1 or less according to NCI-CTCAE v5.0 at least 4 weeks before treatment enrollment, except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy.\n\n    Note: Other Grade 2 AEs that are deemed clinically insignificant by treating physician and in consultation with Medical Monitor are permitted.\n20. Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.\n\nExclusion Criteria:\n\n1. Patients with symptomatic and\u002For untreated brain metastases. Note: Patients with definitively-treated brain metastases will be considered for enrollment after discussion with Medical Monitor if prior to the start of NMA-LD the patient is asymptomatic, clinically stable for ≥3 months, there are no new brain lesions via magnetic resonance imaging (MRI) post-treatment, and the patient does not require corticosteroid treatment.\n2. Patients with leptomeningeal carcinomatosis.\n3. Patients with an active concurrent or history within the past 3 years of invasive malignancy, except for non-melanoma skin cancer, cervical and bladder carcinoma in situ, good prognosis ductal carcinoma in situ of the breast, or prostate carcinoma that is in remission under androgen deprivation therapy for \\> 2 years. Other exceptions may apply and require discussion between the Investigator and the Medical Monitor.\n4. Patients with an active systemic infection requiring anti-infective treatment within 14 days before preparative lymphodepleting therapy.\n5. Patients with active hepatitis B or hepatitis C.\n6. Patients with active autoimmune disease requiring immunosuppressive treatments.\n7. Patients with a history of organ or bone marrow transplantation.\n8. Patients with any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n9. Patients requiring regular treatment with steroids. Note: use of inhaled, topical steroids and use of systemic physiologic corticosteroid replacement therapy are permitted.\n10. Patients with current or history within the last 6 months, as determined by the Investigator, of clinically significant, progressive, and\u002For uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.\n11. Patients with a history of coronary revascularization or ischemic symptoms.\n12. History of idiopathic pulmonary fibrosis or evidence of active pneumonitis (any origin)\n13. Patients with allergies to any of the compounds included in any of the treatment products.\n14. Patients with contraindications for cyclophosphamide and fludarabine at per protocol doses (see Investigator Brochure for details).\n15. Patients who have received any approved anti-cancer cytotoxic, anti-angiogenic and ICB therapy including radiotherapy within 4 weeks before preparative lymphodepleting therapy.\n\n    Exception: palliative radiotherapy for bone metastasis \\> 2 weeks before preparative lymphodepleting therapy, denosumab, bisphosphonates, androgen deprivation therapy for prostate cancer and hormonal therapy for breast cancer.\n16. Patients who have received any non-cytotoxic drug and molecular targeted therapy within 4 weeks before preparative lymphodepleting therapy (or within five half-lives of the investigational product, whichever is shorter).\n17. Patients who have received any investigational agent within 4 weeks before preparative lymphodepleting therapy (or within five half-lives of the investigational product, whichever is shorter).\n18. Patients who have received a live, attenuated vaccination within the 4 weeks before lymphodepleting therapy.\n19. Patients who have undergone major surgery in the previous 3 weeks before lymphodepleting therapy.\n20. Patients who have previously received any investigational cell or gene therapies.\n21. Women of childbearing potential who are pregnant or breastfeeding.\n22. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n23. Other severe, acute, or chronic medical condition or laboratory abnormality that may increase the risk associated with study assessed by the Investigator.",{"count":85,"type":20},15,[87],"PHASE1","This is a phase I, open-label, non-randomized, multicenter, dose-escalation trial designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of autologous p95HER2.CAR-TECH2Me T cells in patients with selected advanced HER2-positive (3+) cancers, including locally advanced, recurrent, or metastatic breast, gastric, endometrial, and other selected solid tumors. The study will also assess pharmacokinetics, pharmacodynamics, and immunogenicity of p95HER2.CAR-TECH2Me following intravenous administration.\n\nTreatment consists of non-myeloablative lymphodepletion chemotherapy with cyclophosphamide and fludarabine administered on Days -4 to -2, followed by a single infusion of p95HER2.CAR-TECH2Me cells on Day 0. The investigational product is a live cell suspension of autologous CAR-T lymphocytes derived from the patient's peripheral blood. Premedication will be administered before cell infusion according to protocol requirements.\n\nThe primary objective of the study is to evaluate the safety and tolerability of p95HER2.CAR-TECH2Me and to identify the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Primary endpoints include the nature and frequency of adverse events, serious adverse events, clinically relevant changes in laboratory parameters, electrocardiograms, vital signs, physical examination findings, and ECOG performance status, as well as the incidence and nature of dose-limiting toxicities. Adverse events will be graded according to NCI CTCAE v5.0, with cytokine release syndrome and neurotoxicity graded according to established consensus criteria.\n\nSecondary objectives include evaluation of preliminary anti-tumor activity and survival outcomes. Secondary endpoints include objective response rate, duration of response, progression-free survival according to RECIST v1.1 as assessed by the investigator, and overall survival.\n\nApproximately 15 patients are planned for enrollment over an estimated 36 to 48 months. The total study duration is expected to be approximately 60 months from the time the first subject signs the pre-screening informed consent form until the last subject completes the final study-related follow-up contact.",[27,90,91],"Metastatic Breast Cancer","Endometrial Cancer Metastatic","2026-05-19",{"date":94,"type":35},"2026-05-22",{"date":96,"type":35},"2026-04-29",{"date":98,"type":20},"2041-04-01",{"name":100,"class":42},"Vall d'Hebron Institute of Oncology",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":141,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":110,"type":20},150,[87],"The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,27,131,132,133,134,135,136,137,138,139,140],"Solid Tumor","Advanced Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Cancer","Ovarian Neoplasms","Ovarian Carcinoma","Metastatic Ovarian Carcinoma","Endometrial Neoplasms","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Triple Negative Breast Neoplasms","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[142,143,144,145,146,147],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":150,"type":35},"2026-04-21",{"date":152,"type":35},"2024-09-19",{"date":154,"type":20},"2029-05",{"name":156,"class":75},"NiKang Therapeutics, Inc.",19,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":43},"100617225","phase-2-iparomlimab-and-tuvonralimab-ql1706-combined-with-chemotherapy-for-previously-untreated-advanced-or-metastatic-gastric-or-gastroesophageal-junction-cancer-100617225","NCT07315854","Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer","A Prospective, Single-Center, Exploratory Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy in the Treatment of Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures.\n* Age 18-80 years, gender is not limited.\n* Patients with locally advanced unresectable, recurrent unresectable, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) confirmed by imaging and other examinations, and histopathologically confirmed as adenocarcinoma.\n* Provide a report confirming HER2 overexpression or amplification negativity; defined as IHC 0\u002F1+, or IHC 2+ with FISH\u002FISH negative.\n* No prior systemic therapy for advanced or metastatic GC\u002FGEJC (including anti-HER-2 therapy). Patients who have received adjuvant or neoadjuvant therapy (including chemotherapy, radiotherapy, or chemoradiotherapy) for GC\u002FGEJC are eligible if the time to first recurrence or disease progression is greater than 6 months from the end of the last treatment. Prior use of anti-tumor Traditional Chinese Medicine preparations is allowed but must be discontinued at least 2 weeks before enrollment.\n* ECOG performance status score of 0 or 1.\n* Must have at least one measurable lesion according to RECIST v1.1 definitions.\n* All acute toxicities caused by prior anti-tumor therapy or surgery must have resolved to Grade 0-1 (according to NCI CTCAE v5.0) or to the level specified in the inclusion\u002Fexclusion criteria. Alopecia, fatigue, and hearing loss, or other toxicities considered by the investigator not to pose a safety risk to the subject, are excluded.\n* Adequate organ function (laboratory tests within 7 days prior to treatment):\n\n  * Hematology (No blood transfusion, G-CSF use, or drug correction within 14 days prior to screening):\n  * White blood cell count (WBC) ≥ 3,000\u002Fmm³ (3.0 × 10⁹\u002FL);\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ (1.5 × 10⁹\u002FL);\n  * Platelet count (PLT) ≥ 100,000\u002Fmm³ (100 × 10⁹\u002FL);\n  * Hemoglobin (Hb) ≥ 9.0 g\u002FdL (90 g\u002FL).\n* Biochemistry (No albumin transfusion within 14 days prior to screening):\n\n  * Albumin ≥ 3.0 g\u002FdL (30 g\u002FL);\n  * Creatinine ≤ 1.5 × Upper Limit of Normal (ULN) or Creatinine Clearance ≥ 50 ml\u002Fmin (calculated using the Cockcroft-Gault formula);\n  * Total Bilirubin (BIL) ≤ 1.5 × ULN;\n  * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) levels ≤ 2.5 × ULN; for patients with liver metastases, ≤ 5 × ULN.\n* Coagulation: International Normalized Ratio (INR) ≤ 1.5, Prothrombin Time (PT), and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.\n* Urine: Urine protein \\\u003C 2+; if urine protein is ≥ 2+, 24-hour urine protein quantification must be ≤ 1g.\n* Life expectancy ≥ 3 months.\n* Women of childbearing potential must undergo a serum or urine pregnancy test within 7 days before starting treatment, with a negative result, and must not be lactating. All enrolled patients must use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.\n\nExclusion Criteria:\n\n* Known squamous cell carcinoma, undifferentiated carcinoma, other histological types of gastric cancer, or mixed gastric cancer containing other histological types.\n* Active malignant tumors within the past 2 years, other than the tumor under study. Exceptions include subjects with locally curable cancers (that have been cured), such as basal or squamous cell skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix or breast.\n* Participation in a study of an investigational drug or receipt of investigational treatment or use of an investigational device within 4 weeks prior to the first dose.\n* Enrollment in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study (defined as \\>4 weeks since the last dose of the previous clinical study or \\>5 half-lives of the study drug).\n* Untreated Central Nervous System (CNS) metastases, or uncontrolled or symptomatic active CNS metastases. Patients with fully treated CNS metastases may be enrolled if neurological symptoms have returned to baseline levels at least 4 weeks prior to enrollment (excluding residual signs or symptoms related to CNS treatment). Additionally, subjects must have discontinued corticosteroids or be on a stable or tapering dose of prednisone ≤ 10 mg\u002Fd (or equivalent dose of other corticosteroids) for at least 4 weeks prior to enrollment.\n* Pleural effusion or ascites that remains uncontrolled despite puncture and drainage within 14 days prior to enrollment; symptomatic or moderate-to-large pericardial effusion.\n* Weight loss of more than 20% within 2 months prior to enrollment.\n* Received the following treatments or medications prior to enrollment:\n\n  * Major surgery within 28 days prior to enrollment (tissue biopsy for diagnosis and PICC\u002Fport implantation are allowed).\n  * Use of immunosuppressive drugs within 14 days prior to enrollment, excluding nasal\u002Finhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤ 10 mg\u002Fd prednisone or equivalent).\n  * Vaccination with live attenuated vaccines within 28 days prior to enrollment or planned during the study period and within 60 days after the end of study drug treatment.\n  * Local anti-tumor therapy (e.g., radiotherapy or tumor embolization) within 28 days prior to enrollment.\n* Diagnosed with any other malignant tumor within 5 years prior to entering the study, except for cured cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma amenable to local treatment.\n* Presence of any active, known, or suspected autoimmune disease. Subjects in a stable state not requiring systemic immunosuppressive therapy are allowed, such as Type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia).\n* Prior treatment with any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.\n* Significant clinical bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment; gastrointestinal perforation and\u002For fistula within 6 months prior to enrollment; arterial\u002Fvenous thromboembolic events within 6 months prior to enrollment, such as cerebrovascular accident (including TIA, cerebral infarction), deep vein thrombosis, and pulmonary embolism (except for those with gastric cancer bleeding\u002Fperforation where symptoms disappeared after surgical resection).\n* Major vascular disease within 6 months before the start of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).\n* Severe, unhealed, or dehisced wounds, active ulcers, or untreated fractures.\n* Presence of \\> Grade 1 peripheral neuropathy.\n* History of intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment, including incomplete obstruction related to the underlying disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. Patients with incomplete obstruction\u002Fobstruction syndrome at initial diagnosis who have symptom relief after definitive (surgical) treatment may be enrolled.\n* Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia, etc.).\n* Known history of active tuberculosis.\n* Known allergy to the study drug or any of its excipients; or history of severe allergic reactions to other monoclonal antibodies.\n* HIV infection or known Acquired Immunodeficiency Syndrome (AIDS); untreated active hepatitis (Hepatitis B defined as HBV-DNA ≥ 500 IU\u002Fml; Hepatitis C defined as anti-HCV positive and HCV RNA above the lower limit of detection) or co-infection with Hepatitis B and C.\n* Poorly controlled clinical cardiac symptoms or diseases, such as: (1) NYHA Class II or higher cardiac insufficiency or LVEF \\\u003C 50% on echocardiography; (2) Severe\u002Funstable angina; (3) Myocardial infarction within 12 months prior to enrollment; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) Symptomatic congestive heart failure; (6) QTc \\> 480 ms.\n* Systemic use of antibiotics ≥ 7 days within 4 weeks prior to enrollment, or unexplained fever \\> 38.5°C during screening\u002Fbefore first dose (fever due to tumor causes is allowed per investigator judgment).\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Participation in any other drug clinical study within 4 weeks or 5 half-lives prior to enrollment.\n* Known history of psychotropic drug abuse or drug addiction.\n* Presence of other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of participation, interfere with study results, or render the patient unsuitable for the study in the opinion of the investigator.","80 Years",{"count":167,"type":20},32,[55],"The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer.\n\nThe main questions it aims to answer are:\n\n1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will：\n\n1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks.\n2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles.\n3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity.\n4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.",[171,60,172,27],"Gastric Cancer (GC)","Advanced Gastric Cancer",[174,175,176,177,178,179,129],"Iparomlimab and Tuvonralimab","QL1706","Advanced or Metastatic Gastric Cancer","PD-1\u002FCTLA-4 Bispecific Antibody","Immunotherapy","Chemotherapy Combination","2026-01-02",{"date":182,"type":35},"2026-01-06",{"date":184,"type":35},"2025-11-04",{"date":186,"type":20},"2029-12-31",{"name":188,"class":42},"Beijing Friendship Hospital",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":101},"100600854","phase-2-safety-and-efficacy-of-shr2554-combined-with-other-antitumor-therapies-in-gastric-or-gastro-oesophageal-junction-adenocarcinoma-100600854","NCT07102901","Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma","A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.\n2. Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening.\n3. Is willing to provide an adequate tumor sample.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.\n\nExclusion Criteria:\n\n1. Presence of dysphagia or other factors impairing oral administration of SHR2554.\n2. Has previously been treated with any enhancer of zeste homolog inhibitors.\n3. Uncontrolled or significant cardiovascular disease.\n4. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n5. Has active autoimmune diseases requiring systemic corticosteroids\u002Fimmunosuppressants.\n6. History of known hypersensitivity to SHR2554 or excipients.\n7. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.\n8. Diagnosis of other malignancies within 5 years prior to the first dose of investigational product.\n9. Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected\u002Fconfirmed ILD, or clinically significant pulmonary disease history.\n10. Psychological, social, familial, or geographical factors that would prevent regular follow-up.","75 Years",{"count":198,"type":20},351,[55],"This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.",[172,27,202],"Gastroesophageal Junction Adenocarcinoma","2025-09-09",{"date":205,"type":35},"2025-09-10",{"date":207,"type":35},"2025-09-05",{"date":209,"type":20},"2027-12",{"name":211,"class":75},"Jiangsu HengRui Medicine Co., Ltd.",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":196,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":43},"100575144","cytoreductive-gastrectomy-after-systemic-therapy-versus-systemic-therapy-alone-for-limited-metastasis-gastric-cancer-100575144","NCT06768463","Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer","Cytoreductive Gastrectomy After Systemic Therapy Versus Systemic Therapy Alone For Limited Metastasis Gastric Cancer: An Open-label Randomized Controll Trial","CYGAS-GC","Inclusion criteria General criteria\n\n* Age 18-75\n* GCLM detected on surgical exploration and demonstrated by histology or cytology\n* Localized peritoneal carcinomatosis (P1 or P2 score), according to the classification of the Japanese Research Society for Gastric Cancer\n* Liver metastasis lesions of maximum diameter ≤5 cm\n* Para-aortic lymph node metastasis below the coeliac axis or above the inferior mesenteric artery (lymph node 16a1\u002Fb2 of maximum diameter≥1cm)\n* Bilateral or unilateral Krukenberg tumors were allowed and considered 1 incurable organ site\n* The accepted patient has two metastases\n* Baseline Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 1\n* Basic laboratory tests demonstrating adequate bone marrow function (neutrophil count \\> 1500mm3, haemoglobin \\> 8g\u002FdL, platelet count \\> 100,000\u002Fmm3), adequate liver function (bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within upper limits of normal), adequate renal function (serum creatinine within the upper limit of normal)\n* Expected survival \\> 3 months\n* Able to tolerate enteral nutrition and adequate mental capacity to give informed consent\n* Completed 4 cycles of first-line standard-of systemic therapy\n* Repeat diagnostic laparoscopy after first-line treatment prior to randomization demonstrating feasible resection.\n\nEligibility criteria for resection \\& extent of proposed resection\n\n* Staging scans (cross-sectional imaging) demonstrating no extra metastases (lung, bone,...)\n* Cross-sectional imaging demonstrating no local progression of PM\n* PCI score \\\u003C12\n* Cytology +ve alone (no gross PM) permissible for enrolment\n* Feasible R0 resection (reasonable chance of negative margins on histology)\n* Feasible D1, D1+ or D2 lymphadenectomy\n\nExclusion criteria\n\n* Any extra-abdominal metastasis at diagnosis or during systemic treatment.\n* Past history of malignancy other than gastric cancer diagnosed in the last 5 years except for basal cell carcinoma of skin or preinvasive cancer of cervix\n* Patients in the reproductive age who declined to use an adequate means of contraception\n* Significant disease or conditions which, in the investigator's opinion, would exclude patient from the study\n* Uncontrolled concurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant and lactating females\n* Prior surgical treatment for GC involving resection\n* Clinical or radiological progression during 1st line systemic treatment\n\n  * Patients with radiological progression of LM (determined by RECIST criteria) to be excluded as disease is likely not responding well to 1st line treatment.\n  * Patients with clinical progression of LM as defined by increasing ascites requiring intervention (ascitic tap\u002Fdrain, hospital admission etc) or causing significant symptoms to the patient (tense distended abdomen, early satiety, shortness of breath etc).\n\n    * Ascites volume as a reflection of disease control is difficult to assess and quantify or a reflection of disease progression. (15)\n* Any patient deemed unresectable or requiring extensive resection beyond procedure approved in the study protocol\n\n  * PCI \\> 12\n  * Extensive bowel \u002F mesentery involvement requiring \\>2 separate \u002F non-contiguous small or large bowel resections in addition to the gastrectomy\n  * Involvement of the head of pancreas or bile duct\n  * PM or nodal disease in the hepatoduodenal ligament\n  * Involvement of major vascular structures\n  * Involvement of esophagus precluding a reasonable chance of R0 resection by transhiatal approach Withdrawal Criteria\n* Patient decides to withdraw from the study, or\n* The investigator concludes that it is in the patient's best interest to discontinue study treatment.",{"count":221,"type":20},250,[223],"NA","The results of the current studies to determine the optimal strategy for metastatic gastric cancer remain contrversial worldwide.\n\nHypothesis: Cytoreductive Gastrectomy After Systemic Therapy will improve survival time for metastasis gastric cancer compared to Systemic Therapy alone.",[27,129,226,227],"Systemic Therapy","Cytoreductive Gastrectomy","2025-08-20",{"date":230,"type":35},"2025-08-27",{"date":232,"type":35},"2025-08-01",{"date":234,"type":20},"2027-12-10",{"name":236,"class":42},"University Medical Center Ho Chi Minh City (UMC)",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":196,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100572215","phase-2-first-line-treatment-with-rc48-plus-sintilimab-and-s-1-in-advanced-gastric-cancer-rcts2-100572215","NCT06730373","First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)","A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)","Inclusion Criteria:\n\n1. Aged18-75 years, gender is not limited;\n2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;\n3. HER2-Positive (IHC3+or IHC2+\u002FFISH+) ;\n4. Has at least 1 measurable lesion as determined by RECIST 1.1;\n5. There is no systematic treatment in the past, or the patient has received neoadjuvant\u002Fadjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n7. Adequate organ function;\n8. The life expectancy is at least 3 months;\n\nExclusion Criteria:\n\n1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;\n2. Cardiovascular and cerebrovascular events that are not well controlled;\n3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.\n4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);\n5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;\n6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;\n7. Brain metastasis or leptomeningeal metastasis;\n8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;\n9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);\n10. Any major surgery was performed ≤ 28 days before the first trial drug administration;\n11. History of allogeneic stem cell transplantation or organ transplantation;",{"count":245,"type":20},110,[55],"This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.",[249,27,250],"HER2-positive Gastric Cancer","Unresectable Gastric Carcinoma","2024-12-29",{"date":253,"type":35},"2024-12-31",{"date":255,"type":35},"2024-10-17",{"date":257,"type":20},"2027-12-31",{"name":259,"class":42},"Qilu Hospital of Shandong University",20,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":4,"enrollmentInfo":269,"targetDuration":271,"studyType":272,"phases":4,"briefSummary":273,"conditions":274,"keywords":281,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":43},"100494126","liver-embolization-approaches-for-tumor-management-100494126","NCT05714124","Liver Embolization Approaches for Tumor Management","Liver Embolization Approaches for Tumor Management - Retrospective and Prospective Analysis of the Short-, Medium-, and Long-term Clinical Course of Patients Subjected to Embolization Treatment for Primary and Secondary Liver Neoplasms","LEATUM","Inclusion Criteria:\n\n* ≥ 18 yoa\n* patients with patients with primary or secondary liver disease not amenable for surgery or ablation\n* patients with primary or secondary liver tumors candidates for major surgery prior to induction of hypertrophy\n* able and willing to sign informed consent\n\nExclusion Criteria:\n\n* pregnant women\n* patients with uncorrectable coagulopathy\n* diffuse extrahepatic disease\n* for lobar TACE and TARE - presence of bilodigestive shunt\n* for TARE - \\>20% hepatopulmonary shunt",{"count":270,"type":20},580,"5 Years","OBSERVATIONAL","The goal of this evaluate short, medium and long term outcome of the different embolization techniques in patients with primary and secondary hepatic tumors. The main aim is to evaluate progression free survival following embolization in this study population or evaluate residual hepatic volume in cases in which these techniques are used to induce liver regeneration. This study is an observational registry - all patients will follow their normal therapeutic and treatment scheme as per clinical practice, without any additional intervention.",[275,276,277,278,27,279,280],"Hepatocellular Carcinoma","Cholangiocarcinoma","Metastatic Colon Cancer","Metastatic Cancer","Primary Liver Cancer","Metastatic Pancreatic Cancer",[282],"embolization, TAE, TACE, TARE, PVE, HVE","2024-04-11",{"date":285,"type":35},"2024-04-12",{"date":287,"type":35},"2021-05-21",{"date":289,"type":20},"2031-12-31",{"name":291,"class":42},"IRCCS San Raffaele",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":196,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":311,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":43},"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":301,"type":20},55,[55],"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.",[305,306,307,308,278,27,309,202,310],"Adenocarcinoma","Stomach Neoplasm","Gastroesophageal-junction Cancer","Oligometastatic Disease","Adenocarcinoma of the Stomach","Metastatic Adenocarcinoma",[63,312,313,314,315,316,317,318],"GEJ Cancer","oligometastasis","limited metastatic","hypofractionated radiotherapy","immunotherapy","gastrectomy","metastasectomy","2023-11-07",{"date":321,"type":35},"2023-11-08",{"date":323,"type":35},"2023-01-01",{"date":257,"type":20},{"name":326,"class":42},"Fudan University",{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":196,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":336,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":43},"100516776","phase-1-clinical-study-of-vg161-combined-with-nivolumab-injection-in-patients-with-advanced-metastatic-gastric-cancer-100516776","NCT06008925","Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer","A Dose Ascending, Open Phase Ib\u002FIIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of VG161 Combined With Nivolumab Injection in Subjects With Metastatic Gastric Cancer","Inclusion Criteria:\n\n\\- (Subjects must meet all of the following inclusion criteria to enter the trial)\n\n1. Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.\n2. aged 18 to 75 years (inclusive), male or female.\n3. Patients with advanced metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology.\n4. According to the Guidelines for the Diagnosis and Treatment of Gastric Cancer (CSCO, version 2021), patients must have previously failed two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies), or patients who cannot continue treatment due to severe adverse reactions as judged by the investigator.\n5. Be able to provide paraffin blocks and\u002For tissue sections of previously archived pathological tissues, or willing to undergo tumor tissue biopsy before administration.\n6. The presence of at least one measurable CT scan according to RECIST 1.1 and meeting the requirements for an acceptable injection dose volume (or the first injection dose volume in Phase IIa) in the current dose group, tumor metastases that can be injected under ultrasound guidance (injected lesions are best major tumor burden lesions), and the baseline longest diameter of the injected lesion (lymph node lesions are short diameters) \\> 1.5 cm.\n7. Positive test result for herpes simplex virus I antibodies (HSV-1 IgG or HSV-1 IgM).\n8. ECOG performance status score 0-1.\n9. Expected survival time of more than 3 months.\n10. adequate organ function: 1) blood routine (no blood transfusion or colony-stimulating factor treatment within 14 days): ANC ≥ 1.5 × 10\\^9\u002FL, PLT ≥ 100 × 10\\^9\u002FL, Hb ≥ 85 g\u002FL, lymphocyte count ≥ 1.5 × 10\\^9\u002FL (for lymphocyte count 0.8 × 10\\^9\u002FL to 1.5 × 10\\^9\u002FL, the investigator judged whether to enroll); 2) liver function: TBIL ≤ 1.5 × ULN, ALT ≤ 3 × ULN, AST ≤ 3 × ULN; 3) renal function: Cr ≤ 1.5 × ULN, and creatinine clearance ≥ 45ml\u002Fmin (calculated according to Cockcroft-Gault formula); 4) coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN.\n11. eligible subjects of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose (VG161 or nivolumab, calculated at the later of the day).\n12. Female patients of childbearing age must have a negative blood pregnancy test within 1 day prior to enrollment.\n\nExclusion Criteria:\n\n\\- (Any of the following criteria must be excluded)\n\n1. received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of the study drug, of which oral fluorouracil and small molecule targeted drugs were within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever was longer).\n2. received other unmarketed clinical trial treatment within 4 weeks before the first dose of study drug.\n3. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose of study drug.\n4. Patients who have received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or equivalent doses of the same class of drugs) or other immunosuppressive agents within 14 days before the first dose of study drug; except for the following: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term corticosteroids (≤ 10 mg prednisone equivalent) for prophylaxis (e.g., prevention of contrast agent allergy).\n5. Vaccination within 4 weeks prior to the first dose of study drug.\n6. Adverse reactions of previous anti-tumor treatment have not recovered to CTCAE 5.0 grade evaluation ≤ 1 (except alopecia and other toxicities judged by the investigator as having no safety risk).\n7. Patients with central nervous system metastasis, spinal cord metastasis and\u002For spinal cord compression.\n8. patients with active diverticulitis or symptomatic gastrointestinal ulcers;\n9. in the herpes simplex virus recurrence infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpes keratitis herpeticum, genital herpes, etc., or there are herpes infection-related complications (herpes keratitis, encephalitis, nerve injury, etc.), and intermittent or long-term use of anti-herpes drugs (e.g., acyclovir) treatment, except intermittent local use.\n10. other active uncontrolled infections.\n11. History of immunodeficiency, including positive HIV antibody test and positive Treponema pallidum antibody test.\n12. Patients with active chronic hepatitis B or active hepatitis C (except hepatitis B virus carriers, stable hepatitis B after drug treatment \\[HBV-DNA test negative or \\\u003C 50 IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA test negative\\]);\n13. history of serious cardiovascular disease: 1) ventricular arrhythmia requiring clinical intervention; 2) QTc interval \\> 480 ms; 3) Acute coronary syndrome, congestive heart failure, stroke or other Grade III or higher cardiovascular events within 6 months; 4) New York Heart Association (NYHA) functional classification ≥ II or left ventricular ejection fraction (LVEF) \\\u003C 40%; 5) uncontrolled hypertension after treatment (as judged by the investigator).\n14. Patients with active, or have had and have had autoimmune diseases that may recur (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes, etc.); but excluding patients with clinically stable autoimmune thyroiditis, autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type I diabetes using stable doses of insulin; vitiligo or recovered childhood asthma\u002Fallergy, and patients who do not require any intervention in adulthood.\n15. Having received immunotherapy and have experienced immune-related adverse events (irAEs) such as immune-related pneumonia and myocarditis, which may affect the safety of the investigational drug as judged by the investigator.\n16. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.\n17. Known alcohol or drug dependence.\n18. Mental disorders or poor compliance.\n19. Pregnant or lactating women.\n20. subjects with pleural effusion or pericardial effusion or ascites requiring clinical intervention.\n21. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.",{"count":335,"type":20},43,[87,55],"VG161 is a recombinant human-IL12\u002F15\u002FPDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies). This is an open-label study divided into two parts.\n\nPart 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination.\n\nPart 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.",[27],[340],"Gastric cancer","2023-08-23",{"date":343,"type":35},"2023-08-24",{"date":345,"type":35},"2022-11-17",{"date":347,"type":20},"2026-06",{"name":349,"class":75},"CNBG-Virogin Biotech (Shanghai) Ltd.",{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":196,"enrollmentInfo":357,"targetDuration":4,"studyType":21,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":364,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":369,"leadSponsor":371,"locationsCount":4},"100456990","phase-3-clinical-outcome-of-palliative-surgery-after-translational-therapy-for-metastatic-gastric-cancer-versus-maintenance-chemotherapy-for-metastatic-gastric-cancer-100456990","NCT05230771","Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer","Clinical Outcome of Palliative Surgery After Translational Therapy Versus Maintenance Chemotherapy for Metastatic Gastric Cancer: a Single Center Randomized Controlled Trial","Inclusion Criteria:\n\n* Age from 18 to 75 years\n* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically\n* CT\u002FMRI, PET-CT, or laparoscopic exploration should be performed before surgery to confirm the diagnosis of distant metastasis\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)\n* Estimated survival time was over 3 months\n* The major organs are functioning normally and meet the following criteria:\n\n  (1) Blood routine examination should meet the requirements (no blood transfusion within 14 days):\n  1. HB≥100g\u002FL，\n  2. WBC≥3×109\u002FL\n  3. ANC≥1.5×109\u002FL，\n  4. PLT≥100×109\u002FL； （2）Biochemical tests must meet the following criteria：\n\n  \u003C!-- -->\n\n  1. BIL \\\u003C1.5×upper limit of normal (ULN)，\n  2. ALT and AST\\\u003C2.5ULN，GPT≤1.5×ULN；\n  3. Cr≤1ULN，Ccr \\>60ml\u002Fmin\n* Fertile women must have taken a pregnancy test (serum) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last trial drug; For men, they should be surgically sterilized or agree to use the appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug\n* Did not participate in other clinical studies before and during treatment\n* Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up\n\nExclusion Criteria:\n\n* History of other malignant disease within past five years\n* History of immunodeficiency, including HIV positive, or other acquired congenital immunodeficiency disease, or a history of organ transplantation and allogeneic bone marrow transplantation\n* Accompanied by serious heart, lung, liver and kidney diseases, neuropsychiatric disorders, jaundice or associated severe infection\n* Women during pregnancy or breast-feeding\n* Subjects had poorly controlled cardiovascular clinical symptoms or diseases, including but not limited to:\n\n  1. NYHA class II or more serious heart failure\n  2. unstable angina pectoris\n  3. myocardial infarction within 1 year\n  4. clinically significant ventricular or ventricular arrhythmias that were poorly controlled without or despite clinical intervention",{"count":358,"type":20},120,[56],"This single-center, prospective study was conducted to investigate the efficacy and safety of palliative surgery after translational therapy in the treatment of metastatic gastric cancer. The primary endpoint was 2-year overall survival (OS) rate. Secondary endpoints were median OS, progression-free survival (PFS), 1-year OS, adverse events (AE), severe AE, the quality of life (QOL) and treatment cost.",[27,362,363],"Surgery","Chemotherapy","NOT_YET_RECRUITING","2022-03-30",{"date":367,"type":35},"2022-04-01",{"date":367,"type":20},{"date":370,"type":20},"2027-03-01",{"name":372,"class":42},"Fujian Medical University"]