[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-cancer-or-gastroesophageal-junction-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-cancer-or-gastroesophageal-junction-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100635416","oral-paclitaxel-plus-fruquintinib-verus-investigators-choice-in-second-line-advanced-gastric-cancer-100635416",false,"NCT07552402","Oral Paclitaxel Plus Fruquintinib Verus Investigator's Choice in Second-Line Advanced Gastric Cancer","Paclitaxel Oral Solution Plus Fruquintinib Versus Investigator's Choice as Second-Line Treatment for Advanced Gastric Cancer: A Multicenter, Open-Label, Randomized Controlled Trial","FREEDOM","Inclusion Criteria:\n\n1. Age 18 to 75 years, regardless of sex;\n2. Histologically and\u002For cytologically confirmed advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that has failed first-line therapy or developed intolerable toxicity to first-line treatment.\n3. Presence of at least one measurable lesion per RECIST v1.1 criteria (Note: Previously irradiated lesions cannot be used as target lesions unless unequivocal progression of the lesion after radiotherapy is documented);\n4. Body weight ≥40 kg or BMI \\>18.5 kg\u002Fm²;\n5. No severe hematologic, hepatic, or renal abnormalities:\n\n   1. Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelet count (PLT) ≥100×10⁹\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n   2. Chemistry: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); ALT and AST ≤2.5×ULN in the absence of liver metastases, or ≤5×ULN if liver metastases are present; Serum creatinine (Cr) ≤1.5×ULN;\n   3. Urinalysis: Urine protein ≤1+; If urine protein is ≥2+, a 24-hour urine protein test must be performed, and enrollment is permitted only if the 24-hour urine protein is \\\u003C1.0 g;\n6. ECOG Performance Status (PS) 0-1;\n7. Life expectancy ≥12 weeks;\n8. Signed informed consent.\n\nExclusion Criteria:\n\n1. Known HER2-positive status without prior anti-HER2 therapy (patients who progressed after anti-HER2 therapy are eligible);\n2. History of another primary malignancy within 3 years prior to the first study drug administration, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ carcinomas of the cervix, breast, or other sites;\n3. Receipt of radiotherapy (except palliative radiotherapy), chemotherapy, or small-molecule targeted anticancer therapy within 4 weeks or within 5 half-lives of the agent (whichever is shorter) prior to the first dose of study drug. Patients who discontinued other investigational agents for more than 5 half-lives are eligible for screening. Additionally, treatment with large-molecule targeted anticancer agents within 4 weeks prior to the first study drug dose is prohibited;\n4. Toxicity from prior anticancer therapy not recovered to ≤ Grade 1 or baseline levels (except alopecia; neurotoxicity must have resolved to ≤ Grade 2) within 2 weeks prior to the first study drug administration;\n5. Presence of dysphagia, uncontrolled nausea, vomiting, diarrhea, or known malabsorption syndrome that may interfere with oral drug absorption;\n6. Active gastrointestinal conditions such as gastric\u002Fduodenal ulcer, ulcerative colitis, or bowel obstruction, or any other condition deemed by the investigator to carry a risk of gastrointestinal hemorrhage or perforation; history of gastrointestinal perforation or fistula within the past 6 months; or incomplete recovery from surgery related to gastrointestinal perforation or fistula;\n7. Evidence of significant bleeding or history of bleeding (e.g., hematemesis, hemoptysis) within 2 months prior to randomization. Patients with melena and positive fecal occult blood test must undergo gastroenteroscopy to rule out active bleeding or active ulcer before enrollment;\n8. Requirement for long-term use of proton pump inhibitors (PPIs) or H2-receptor antagonists during the trial; or use of strong inducers or inhibitors of cytochrome P450 (CYP) 3A4 or CYP2C8 within 2 weeks prior to the first study drug dose;\n9. Known active central nervous system (CNS) metastases and\u002For leptomeningeal carcinomatosis;\n10. Active infections or serious infectious diseases, including but not limited to: HIV infection (positive HIV antibody), active hepatitis (active HCV infection defined as positive HCV RNA; HCV antibody-positive but RNA-negative patients are allowed), active HBV infection (HBsAg-positive with HBV DNA \\>2000 IU\u002FmL), bacteremia, severe pneumonia requiring systemic therapy, or active tuberculosis;\n11. Any of the following cardiovascular conditions: myocardial infarction, unstable angina, congestive heart failure (New York Heart Association Class ≥2), or other clinically significant cardiac disease within 6 months prior to the first study drug dose; clinically significant ECG abnormalities (e.g., arrhythmias, QTc interval \\>450 ms); left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography; or uncontrolled hypertension despite treatment with ≥2 antihypertensive agents (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg);\n12. Prior systemic therapy targeting VEGF or VEGFR; or prior treatment with paclitaxel, docetaxel, nab-paclitaxel, liposomal paclitaxel, or polymeric micelle paclitaxel;\n13. Known hypersensitivity to any component of the investigational product;\n14. Pregnant or lactating women;\n15. Uncontrolled symptomatic pleural, peritoneal, or pericardial effusion requiring repeated drainage. Asymptomatic patients with minimal effusions detected only on imaging and who have not received drainage or other intervention within 2 weeks prior to enrollment are eligible;\n16. Major surgery (e.g., craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dosing, or presence of non-healed surgical wounds, ulcers, or fractures. Patients may be enrolled if the investigator determines they are fit to receive study drug ≥2 weeks post-surgery;\n17. History of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic events within 3 months prior to study entry; ongoing anticoagulation therapy with warfarin, low-molecular-weight heparin, or similar agents. Prophylactic low-dose anticoagulation is permitted if INR ≤1.5 per inclusion criteria;\n18. Chronic use of nonsteroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen) or antiplatelet agents (e.g., clopidogrel, ticlopidine, dipyridamole). Low-dose aspirin (≤325 mg\u002Fday) is allowed;\n19. Any other condition deemed by the investigator as unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this study is to evaluate the efficacy and safety of oral paclitaxel solution plus fruquintinib as second-line therapy in adult subjects with advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.",[28],"Gastric Cancer or Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2026-06-10",{"date":37,"type":22},"2028-12-30",{"name":39,"class":40},"Harbin Medical University","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100630818","phase-2-a-clinical-study-of-sintilimab-combined-with-chemothrapy-versus-chemotherapy-as-adjuvant-therapy-for-gastricgastroesophageal-junction-adenocarcinoma-100630818","NCT07492615","A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric\u002FGastroesophageal Junction Adenocarcinoma","Sintilimab Combined With SOX Versus SOX as Adjuvant Therapy for Patients With Stage pIIIC or dMMR\u002FMSI-H Stage pIIIA\u002FIIIB Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Randomized Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Male or female, age ≥18 years.\n3. Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).\n4. Diagnosed with pTNM stage IIIC or pTNM stage IIIA\u002FIIIB.\n5. Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.\n6. Underwent D2 or more extensive radical resection and achieved R0 resection.\n7. Able to swallow tablets normally.\n8. ECOG performance status 0-1.\n9. Life expectancy \\>6 months.\n10. Adequate organ function, subjects must meet the following laboratory criteria:\n\n    1. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL without granulocyte colony-stimulating factor within the past 14 days.\n    2. Platelets ≥100×10\\^9\u002FL without transfusion within the past 14 days.\n    3. Hemoglobin \\>9 g\u002FdL without transfusion or erythropoietin use within the past 14 days.\n    4. Total bilirubin ≤1.5×ULN; if total bilirubin \\>1.5×ULN but direct bilirubin ≤ULN, enrollment is also permitted.\n    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN.\n    6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml\u002Fmin.\n    7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.\n    8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled.\n    9. Cardiac enzyme panel within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are also permitted for enrollment).\n11. For female subjects of childbearing potential, a urine or serum pregnancy test must be negative within 3 days prior to the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or surgically sterile or hysterectomy.\n12. If at risk of conception, all subjects (male or female) must use contraceptive measures with a failure rate of \\\u003C1% per year throughout the treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).\n\nExclusion Criteria:\n\n1. Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.\n2. Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For curatively resected carcinoma in situ).\n3. Currently participating in interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to first dose.\n4. Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).\n5. Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons, interleukins, except for local use to control pleural effusion) within 2 weeks prior to first dose.\n6. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.\n7. Receiving systemic corticosteroid therapy (excluding nasal spray, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to first dose.\n8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n9. Known allergy to any drug used in this study.\n10. Has not adequately recovered from toxicities and\u002For complications caused by any prior intervention prior to starting treatment (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or alopecia).\n11. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive).\n12. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number above the upper limit of normal of the testing laboratory at the study site). Subjects meeting the following criteria may also be enrolled:\n\n    1. HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) prior to first dose, subjects should receive anti-HBV therapy during the entire study chemotherapy treatment to prevent reactivation.\n    2. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed.\n13. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).\n14. Received a live vaccine within 30 days prior to first dose (Cycle 1, Day 1).\n15. Pregnant or breastfeeding women.\n16. Presence of any severe or uncontrolled systemic disease, such as:\n\n    1. Abnormalities in resting ECG in rhythm, conduction, or morphology that are significant and severely symptomatic and difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation.\n    2. Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥2.\n    3. Any arterial thrombotic, embolic, or ischemic event within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.\n    4. Uncontrolled hypertension (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg).\n    5. History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to first dose, or current clinically active interstitial lung disease.\n    6. Active pulmonary tuberculosis.\n    7. Active or uncontrolled infection requiring systemic therapy.\n    8. Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction.\n    9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.\n    10. Poorly controlled diabetes (fasting blood glucose (FBG) \\>10 mmol\u002FL).\n    11. Urinalysis indicates proteinuria ≥++ and confirmed 24-hour urine protein quantification \\>1.0 g.\n    12. Patients with mental disorders who are unable to comply with treatment.\n17. History or evidence of disease, treatment, or laboratory abnormalities that may interfere with the study results, hinder the subject's full participation in the study, or other conditions that the investigator deems unsuitable for enrollment, or the investigator believes there are other potential risks that make participation inappropriate.",{"count":49,"type":22},276,[51],"PHASE2","This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR\u002FMSI-H pIIIA\u002FIIIB stage gastric\u002Fgastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.",[28],[55,56],"Gastrci cancer or Gastroesophageal Junction Adenocarcinoma","Adjuvent Therapy","2026-03-19",{"date":59,"type":33},"2026-03-25",{"date":61,"type":33},"2026-01-29",{"date":63,"type":22},"2033-02-20",{"name":65,"class":40},"Fudan University",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100620535","phase-1-first-in-human-study-of-qls5316-in-solid-tumors-100620535","NCT07358884","First in Human Study of QLS5316 in Solid Tumors","A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of QLS5316 Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n3. Life expectancy ≥ 3 months;\n4. Measurable disease per RECIST v1.1\n5. Adequate organ and marrow function as defined in the protocol\n6. Dose escalation and PK expansion stages: Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, who have failed SOC or SOC is not available\n7. Cohort expansion stage: Patients with histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors that cannot undergo radical surgery or radiotherapy, including CRC, GC\u002FGEJ, HNSCC (mouth, oropharynx, hypopharynx or larynx), EGFR-sensitive mutant NSCLC and EGFR wild-type NSCLC or other advanced malignant solid tumors who have failed SOC or SOC is not available.\n\nExclusion Criteria:\n\n1. Prior treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors, or prior treatment with EGFR and\u002For c-MET targeted ADCs\n2. Untreated or active brain metastasis\n3. Presence of Grade ≥ 2 toxicity (according to the Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) ) left over from prior therapy\n4. Patients with a history of interstitial lung disease (ILD)\u002Fnon-infectious pneumonia, or patients whose suspected ILD\u002Fnon-infectious pneumonia cannot be ruled out by imaging examination at screening; patients with radiation pneumonitis who do not require steroid treatment are allowed to be enrolled;\n5. Patients with a history of active tuberculosis, active autoimmune diseases or autoimmune diseases that may recur\n6. Patients with a history of severe cardiovascular and cardiovascular diseases\n7. Clinically uncontrollable third space effusion\n8. Presence of persistent uncontrolled systemic bacterial, fungal or viral infections or severe infections within 4 weeks before the first dose in the study, or active infections requiring systematic antibiotic treatment within 1 week before the first dose in the study;\n9. Known hypersensitivity reactions or delayed-type sensitization to some components or analogues of the investigational drug",{"count":75,"type":22},300,[77],"PHASE1","This is a first-in-human (FIH) Phase I, multi-center, open-label, study of QLS5316, in patients with advanced solid tumors. The study aim to evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of QLS5316 as monotherapy.",[80,81,28,82,83],"Solid Tumors","Colorectal Cancer","Head and Neck Squamous Cell Carcinoma","Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2026-01-13",{"date":87,"type":33},"2026-01-22",{"date":89,"type":22},"2026-01",{"date":91,"type":22},"2027-12",{"name":93,"class":94},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY"]