[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adjuvant-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adjuvant-treatment":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,84,113,135,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100631994","phase-2-dynamic-ctdna-guided-adjuvant-therapy-in-cstage-iii-and-iva-gastric-or-gastroesophageal-junction-adenocarcinoma-100631994",false,"NCT07507916","Dynamic ctDNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma","Dynamic Circulating Tumor DNA-Guided Adjuvant Therapy in cStage III and IVA Gastric or Gastroesophageal Junction Adenocarcinoma：A Phase 2 Clinical Trial","Inclusion Criteria:\n\n1. Voluntarily participate in the study; fully understand the study and sign the written informed consent form (ICF); be willing and able to comply with all study procedures.\n2. Male or female patients aged ≥18 years and ≤75 years at the time of signing the ICF.\n3. Histologically confirmed, previously untreated gastric cancer or gastroesophageal junction (GEJ) cancer, with adenocarcinoma as the predominant histology. For GEJ cancer, only Siewert type III and Siewert type II tumors not requiring thoracotomy are eligible.\n4. Clinically confirmed stage III or stage IVA disease without distant metastasis, as assessed by the treating physician prior to enrollment.\n5. HER2-negative disease.\n6. Adequate cardiac function and deemed suitable for curative-intent surgical resection. Patients with ischemic heart disease, valvular disease, or other significant cardiac conditions should undergo preoperative evaluation by a cardiologist if clinically indicated.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to enrollment.\n8. Estimated life expectancy of at least 6 months.\n9. Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core antibody (HBcAb). If HBsAg-positive or HBcAb-positive, hepatitis B virus DNA (HBV-DNA) must be \\\u003C1000 copies\u002FmL, \\\u003C200 IU\u002FmL, or below the upper limit of normal (ULN) of the study center.\n10. Negative hepatitis C virus (HCV) antibody.\n11. Adequate organ function, defined as follows (without transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factors within 14 days prior to randomization):\n\n    Hematologic function\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n    * Platelet count ≥ 100 × 10⁹\u002FL\n    * Hemoglobin ≥ 90 g\u002FL Hepatic function\n    * Total bilirubin ≤ 1.5 × ULN\n    * ALT ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver metastases)\n    * AST ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver metastases)\n    * Alkaline phosphatase ≤ 2.5 × ULN (≤ 5.0 × ULN in patients with liver and\u002For bone metastases)\n    * Albumin ≥ 25 g\u002FL Renal function\n    * Creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula) Coagulation function\n    * Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n    * Prothrombin time (PT) ≤ 1.5 × ULN\n    * International normalized ratio (INR) ≤ 1.5 × ULN\n12. Female patients must meet one of the following:\n\n    * Postmenopausal (defined as ≥1 year without menstruation not due to other causes), or\n    * Surgically sterile (bilateral oophorectomy and\u002For hysterectomy), or\n    * Of childbearing potential and meeting all of the following:\n    * Negative serum pregnancy test within 7 days prior to enrollment;\n    * Agree to use highly effective contraception (annual failure rate \\\u003C1%) or remain abstinent from signing the ICF until at least 120 days after the last dose of study drug and 6 months after the last dose of chemotherapy;\n    * Not breastfeeding.\n13. Male patients must agree to abstain from heterosexual intercourse or use effective contraception during chemotherapy and for at least 6 months after the last dose of chemotherapy, and for at least 120 days after the last dose of study drug, if their partner is of childbearing potential or pregnant.\n\nExclusion Criteria:\n\n1. History of another active malignancy within the past 5 years or concurrent malignancy, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.\n2. Presence of distant metastasis (M1) from gastric cancer.\n3. Prior or planned organ or bone marrow transplantation.\n4. History of myocardial infarction within 6 months prior to enrollment, or poorly controlled arrhythmia, including QTc prolongation (QTc ≥450 ms in males or ≥470 ms in females, calculated using Fridericia's formula).\n5. New York Heart Association (NYHA) class III-IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n6. Known human immunodeficiency virus (HIV) infection.\n7. Active pulmonary tuberculosis.\n8. Current or prior interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction that may interfere with the assessment or management of suspected drug-related pulmonary toxicity.\n9. Known active or suspected autoimmune disease, except for patients with stable disease not requiring systemic immunosuppressive therapy at enrollment.\n10. Receipt of a live vaccine within 28 days prior to enrollment (seasonal influenza vaccines with inactivated virus are allowed).\n11. Requirement for systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressive therapy within 14 days prior to enrollment or during the study, except for:\n\n    * Topical or inhaled corticosteroids;\n    * Physiologic replacement therapy with prednisone ≤10 mg\u002Fday in the absence of active autoimmune disease.\n12. Active infection requiring systemic anti-infective therapy within 14 days prior to enrollment (prophylactic antibiotics, such as for urinary tract infection or chronic obstructive pulmonary disease, are allowed).\n13. Prior treatment with immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.\n14. Participation in another clinical study or receipt of investigational treatment within 14 days prior to initiation of this study.\n15. Known severe hypersensitivity to any monoclonal antibody or components of the study drugs.\n16. History of substance abuse or illicit drug use; patients who have stopped alcohol consumption may be enrolled.\n17. Any condition that, in the investigator's judgment, may increase the risk of study participation or interfere with study treatment, compliance, or evaluation.","ALL","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-center, prospective, exploratory study evaluating the use of dynamic circulating tumor DNA (ctDNA) monitoring in the postoperative adjuvant treatment setting for patients with stage III or stage IVA gastric or gastroesophageal junction adenocarcinoma.\n\nAfter curative-intent surgery, patients remain at risk of disease recurrence. Postoperative treatment decisions are currently based on clinicopathological factors, which may not fully reflect minimal residual disease. ctDNA is a blood-based biomarker that can detect tumor-derived DNA fragments and may provide additional information on recurrence risk.\n\nIn this study, ctDNA will be assessed at predefined perioperative and postoperative time points using peripheral blood samples. The primary objective is to evaluate 1-year disease-free survival. Secondary objectives include survival outcomes, safety, and longitudinal changes in ctDNA status. The findings of this exploratory study may inform future research on ctDNA-guided postoperative management in gastric cancer.",[27,28,29,30],"ctDNA","Gastric Cancer","Gastroesophageal Junction (GEJ) Adenocarcinoma","Adjuvant Treatment","NOT_YET_RECRUITING","2026-03-30",{"date":34,"type":35},"2026-04-02","ACTUAL",{"date":37,"type":21},"2026-04-01",{"date":39,"type":21},"2029-12-31",{"name":41,"class":42},"Fudan University","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100598403","phase-2-evaluating-the-use-of-a-medication-switch-vs-guideline-directed-interventions-for-relieving-side-effects-of-aromatase-inhibitors-among-breast-cancer-patients-100598403","NCT07071038","Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients","The 'SWIVEL' Study (Switch Vs Effects Relief): Effectiveness of a Medication 'Switch' vs Guideline-Directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients","SWIVEL","Inclusion Criteria:\n\n* Histologic documentation of DCIS or invasive breast cancer by core needle or incisional biopsy.\n* The DCIS or invasive cancer must be estrogen receptor alpha (ER)-positive\n* The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of \\\u003C1.8 if IHC is 2+ or if IHC has not been done)\n* Clinical Stage I-III invasive breast cancer or DCIS\n* Patients for whom adjuvant treatment with one of the following would be clinically indicated: letrozole, anastrozole, exemestane\n* Patients who anticipate continuing with adjuvant endocrine therapy for a minimum of 2 years at the time of registration\n* Women over 18 years of age who are post-menopausal, defined as last menstrual period \\>2 years prior to registration, or \\>1 year prior to registration with FSH and estradiol in post-menopausal range.\n* Patients must meet the following clinical laboratory criteria:\n\n  * Absolute neutrophil count (ANC) \\>1,000\u002Fmm3 and platelet count \\> 75,000\u002Fmm3\n  * Total bilirubin \\\u003C1.5 x the upper limit of the normal range (ULN).\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 3 x ULN.\n* Ability to give informed consent.\n\nExclusion Criteria:\n\n* Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.\n* Any other adjuvant therapy for breast cancer. Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.\n* Patients who are prescribed tamoxifen as the first endocrine therapy rather than an aromatase inhibitor.\n* Women who are pregnant or lactating.\n* Prisoners.",{"count":52,"type":21},62,[24],"Researchers have learned that about 50% of women do not finish the standard 5-year breast cancer treatment with an aromatase inhibitor. An aromatase inhibitor is hormone therapy that lowers the chance of breast cancer coming back (recurring) after surgery by blocking an enzyme in fat tissue called aromatase; aromatase changes other hormones in the body to estrogen. Women who do not complete the standard 5-year treatment are at higher risk of their cancer coming back. The goal of this research is to prevent breast cancer from coming back after surgery by helping women to stay on treatment with aromatase inhibitors. Researchers believe the best path to help women to stay on treatment is to create a better way to manage (control) side effects.",[56,30,57],"Breast Cancer","Early Stage Breast Cancer",[59,60,61,62,63,64,65,66,67,68,69,70,71,72],"breast cancer surgery","aromatase inhibitor","aromatase side effects","hormone therapy","quality of life","adherence","early breast cancer","switching medications","hormonal therapy","letrozole","anastrozole","exemestane","tamoxifen","adjuvant therapy","RECRUITING","2026-02-10",{"date":76,"type":35},"2026-02-12",{"date":78,"type":35},"2025-10-17",{"date":80,"type":21},"2027-08-05",{"name":82,"class":42},"Dartmouth-Hitchcock Medical Center",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100593744","phase-3-a-study-to-assess-the-efficacy-and-safety-of-firmonertinib-versus-placebo-for-adjuvant-treatment-in-participants-with-stage-ib---iiib-nsclc-with-uncommon-epidermal-growth-factor-receptor-egfr-mutations-following-complete-surgical-resection-with-or-without-adjuvant-chemotherapyfirmost-100593744","NCT07010419","A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST）","A Global Phase 3, Double-Blind, Randomized, Controlled Multicenter Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy (FIRMOST)","FIRMOST","Inclusion Criteria:\n\n1. Sign the Informed Consent Form (ICF).\n2. Aged ≥ 18 years old. Participants from Japan\u002FTaiwan aged ≥ 20 years old.\n3. Histologically confirmed diagnosis of primary non-small cell lung cancer (NSCLC) of predominantly non-squamous histology.\n4. Underwent complete surgical resection of primary lung cancer and systematic lymph node dissection (R0 resection).\n5. Classified post-operatively as Stage IB, II, IIIA, or IIIB (T3N2M0 only) on the basis of pathologic criteria, with the disease staging following the 9th Edition TNM Staging Classification: Lung Cancer issued by Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC).\n6. Documented results of the presence of uncommon EGFR mutations (exon 20 insertion mutations, PACC mutations, and\u002For classical-like mutations, either as single mutations or as co-mutations), in tumor tissue or blood via a validated NGS or validated PCR assay.\n\nExclusion Criteria:\n\nA participant would be excluded from the study if he\u002Fshe meets any of the following:\n\n1. NSCLC with EGFR Exon 19 deletion or L858R or C797S mutation.\n2. Incomplete resection (R1\u002FR2) or segmentectomy or wedge resection only.\n3. Prior treatment with any of the following:\n\n   1. Prior treatment with any antineoplastic therapy other than standard platinum-based doublet adjuvant chemotherapy.\n   2. prior treatment with neoadjuvant therapy.\n4. Concurrent malignant tumors other than the primary tumor; participants with cancers that can be treated locally and cured may be eligible.\n5. Previous ILD (including drug-induced ILD) or active ILD\u002Factive radiation pneumonitis.",{"count":93,"type":21},338,[95],"PHASE3","This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with uncommon EGFR mutations (exon 20 insertions, PACC and classical-like mutations) after complete surgical resection with or without adjuvant chemotherapy.\n\nAbout 338 eligible participants will be enrolled and randomized in a 1:1 ratio to receive either firmonertinib 240 mg QD or placebo QD in 21-day treatment cycles. Before randomization, the participant must have undergone complete surgical resection (R0 resection), must have sufficiently recovered from surgery, and must have completed adjuvant chemotherapy (if applicable). The participants will receive firmonertinib or placebo as adjuvant treatment until unacceptable toxicity, withdrawal of informed consent, disease recurrence, initiation of new antitumor treatment, completion of treatment, or other end of treatment reason is met.",[98,30],"NSCLC",[100,98,101],"EGFR","Firmonertinib","2025-06-05",{"date":104,"type":35},"2025-06-08",{"date":106,"type":35},"2025-05-28",{"date":108,"type":21},"2032-04-30",{"name":110,"class":111},"Allist Pharmaceuticals, Inc.","INDUSTRY",2,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100589751","phase-2-iparomlimab-and-tuvonralimab-injection-ql1706-combined-with-bevacizumab-for-postoperative-adjuvant-therapy-in-hepatocellular-carcinoma-hcc-with-high-risk-of-recurrence-100589751","NCT06958484","Iparomlimab and Tuvonralimab Injection (QL1706) Combined With Bevacizumab for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma (HCC) With High Risk of Recurrence","Iparomlimab and Tuvonralimab Injection (QL1706) Combined With Bevacizumab for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma (HCC) With High Risk of Recurrence: A Multicenter, Open-Label, Single-Arm, Phase II Study","Inclusion Criteria:\n\n1. Voluntarily participate in this study and sign the informed consent form;\n2. Age 18-100 years old, male or female;\n3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging;\n4. CNLC PHASE I-II;\n5. After surgical resection or local ablation, the intraoperative pathology shows that there is no residual resection margin, or R0 is confirmed by imaging within 4\\~8 weeks after surgery;\n6. Have at least one high-risk recurrence factor:\n\n(Definition of high-risk recurrence factors: Definition of high-risk recurrence factors: after radical surgery: presence of a single tumor \\>5 cm in diameter; Number of tumors\\>=3; concomitant vascular invasion (microvascular invasion or Vp1-2); Tumor grade III-IV; Post-ablation: 1. Single tumor \\>2cm but \\\u003C= 5cm; 2. Multiple tumors: 2-4, all tumors \\\u003C= 5 cm); 7. ECOG PS score: 0\\~1 points; 8. Child-Pugh Liver Function Rating: Grade A (\\\u003C = 6 points) 9. Expected survival time \\>=12 months; 10. The laboratory test values within 3 days before the first dose meet the following requirements:\n\n1. Routine blood test: (except for hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor \\[G-CSF\\], no correction with medication within 2 weeks prior to screening):\n\n   Absolute neutrophil count \\>=1.5×10\\^9\u002FL; Platelets \\>=75×10\\^9\u002FL; Hemoglobin \\>=90 g\u002FL;\n2. Biochemical examination:\n\n   serum albumin \\>=30g\u002FL; Serum total bilirubin \\\u003C = 1.5×ULN; ALT and AST \\\u003C= 3×ULN; Serum creatinine \\\u003C = 1.5×ULN; or Cr clearance \\>50 mL\u002Fmin\n3. International normalized ratio (INR) \\\u003C = 1.2 or prothrombin time (PT) outside the range of normal controls \\\u003C = 2 seconds;\n4. urine protein \\\u003C2 (if urine protein \\>=2, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification \\\u003C1.0g can be enrolled); 11. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, you need to test for HBV-DNA, and the HBV-DNA needs to be \\\u003C2000 IU\u002FmL (if the site only has a copy\u002FmL testing unit, it must be \\\u003C 104 copy\u002FmL); For subjects with HBV-DNA\\>=2000 IU\u002FmL, at least 1 week of antiviral therapy (only nucleosides such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenol tablets are allowed) prior to the first dose, and the viral copy number decreased by more than 10-fold (1 lg) compared to before the first dose. For patients with HBV infection, antiviral therapy is required throughout the study. Hepatitis C virus (HCV)-RNA positive subjects must be on antiviral therapy as per treatment guidelines; 12. Women of childbearing potential must have a negative pregnancy test (βHCG) before starting the first dose. Women of childbearing potential and men (sexually active with women of childbearing potential) must agree to contraception during treatment and within 6 months of the last dose.\n\nExclusion Criteria:\n\n1. It is known that there are fibrotic plate HCC, sarcomatoid HCC or mixed-type cholangiocarcinoma and HCC;\n2. There is evidence of residual, recurrent or metastatic disease;\n3. History of hepatic encephalopathy;\n4. Previous receipt of allogeneic stem cell or solid organ transplantation, or on the waiting list for liver transplantation;\n5. Any treatment before HCC resection or ablation, including systemic treatment (including experimental drugs) and local treatment, such as TACE; and subjects who received more than one cycle of adjuvant TACE treatment after surgical resection;\n6. Within 5 years before the first medication, there is a history of malignant tumors other than HCC, with negligible risk of metastasis or death (such as 5-year OS rate \\> 90%), such as fully treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer;\n7. Co-infection with HBV and HCV, co-infection with HBV and delta hepatitis virus infection;\n8. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or chest CT scan at screening shows evidence of active pneumonia;\n9. Active tuberculosis;\n10. History of autoimmune diseases or immunodeficiency diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome or multiple sclerosis;\n11. Severe infection within 4 weeks before the first medication, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia;\n12. Received oral or intravenous antibiotic treatment within 2 weeks before the first medication;\n13. Use of non-steroidal anti-inflammatory drugs (NSAIDs) for daily treatment of chronic diseases;\n14. Have bleeding predisposition or significant evidence of coagulation dysfunction (without anticoagulant treatment);\n15. Currently or recently using aspirin or full-dose oral or intravenous anticoagulants;\n16. Hemorrhage events due to untreated or incompletely treated esophageal and\u002For gastric varices within 6 months before the first medication;\n17. Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the first medication;\n18. Inadequate control of arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure \\>= 90 mmHg) (based on the average value of \\>= 2 measurements of BP readings), allowing the above parameters to be achieved through the use of antihypertensive treatment; previous occurrence of hypertensive crisis or hypertensive encephalopathy;\n19. Significant uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL, or corrected serum calcium \\> ULN) within 6 months before the first medication;\n20. Within 3 months of having severe cardiovascular diseases (such as NYHA class II or above heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmias or unstable angina pectoris;\n21. Clinically significant ascites;\n22. Within 6 months before the first medication, having a history of intra-abdominal inflammation, including but not limited to peptic ulcer, diverticulitis or colitis;\n23. Within 6 months before the first medication, having a history of abdominal or tracheoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess;\n24. Severe, non-healing or ruptured wounds, active ulcers or untreated fractures;\n25. Performed hollow needle biopsy or other minor surgeries within 3 days before the first medication, excluding the placement of vascular access devices. 26. Within 4 weeks prior to the first administration of the drug, underwent major surgery, or was expected to undergo major surgery during the study period;\n\n27\\. Had previously used systemic immunostimulants or immune checkpoint blockade therapy; 28. Was expected to receive systemic immunosuppressive drugs (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-α \\[TNF-α\\] preparations) within 2 weeks prior to the first administration of the drug, or was expected to receive systemic immunosuppressive drugs during the study treatment period; 29. Was vaccinated with live vaccines within 30 days prior to the first administration of the drug, or was expected to receive such vaccines during the treatment period or within 5 months after the last administration; 30. Was known to be allergic to any study drug or excipients; 31. Was contraindicated from using the investigational drug, or had any other diseases, metabolic disorders, physical examination findings, or clinical laboratory findings that might affect the interpretation of results or place the patient at a high risk of treatment complications; 32. Had other factors considered by the investigator as unsuitable for participation in the study.",{"count":121,"type":21},60,[24],"Evaluation of the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706) in combination with bevacizumab for postoperative adjuvant treatment of HCC with high-risk recurrence risk",[125,30],"HCC - Hepatocellular Carcinoma","2025-04-27",{"date":128,"type":35},"2025-05-06",{"date":130,"type":21},"2025-05-01",{"date":132,"type":21},"2027-12-31",{"name":134,"class":42},"The Affiliated Hospital of Xuzhou Medical University",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100575463","phase-2-the-efficacy-and-safety-of-ensartinib-as-adjuvant-therapy-in-stage-i-alk-positive-nsclc-patients-with-high-risk-factors-100575463","NCT06772610","The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors","Inclusion Criteria:\n\n* Aged 18-75 years;\n* ECOG performance status 0-1;\n* Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;\n* Confirmed ALK fusion-positive by FISH, IHC, or NGS;\n* No prior systemic treatment after surgery;\n* At least one high-risk recurrence factor: poorly differentiated tumor, vascular invasion, wedge resection, visceral pleura involvement, uncertain lymph node status, intrapulmonary dissemination;\n* Able to start Ensartinib adjuvant therapy within 4-8 weeks after surgery;\n* Hematological, biochemical, and organ function requirements met: Hemoglobin ≥100 g\u002FL; Absolute neutrophil count ≥1.5×10\\^9\u002FL; Platelet count ≥100×10\\^9\u002FL; Total bilirubin ≤2 times the upper limit of normal; ALT and AST ≤2.5 times the upper limit of normal; Creatinine ≤1.5 times the upper limit of normal; Creatinine clearance ≥60 mL\u002Fmin;\n* Women of childbearing potential must have a negative urine pregnancy test - within 7 days prior to starting treatment;\n* Informed consent obtained from the patient or their legal representative;\n* Men and women of childbearing potential must agree to use reliable - contraception from enrollment in the study until 8 weeks after discontinuation of the study drug.\n\nExclusion Criteria:\n\n* Previous systemic treatment for NSCLC;\n* Previous local radiotherapy for NSCLC;\n* Unable to take oral medications;\n* Known allergy to Ensartinib or any component of this product;\n* History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;\n* Any unstable systemic diseases, including: active infections, uncontrolled hypertension, unstable angina, angina onset within the last 3 months, congestive heart failure (≥ NYHA class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases;\n* Pregnant or breastfeeding women;\n* History of definite neurological or psychiatric disorders, including epilepsy or dementia;\n* Any other conditions that the investigator deems unsuitable for enrollment.",{"count":142,"type":21},40,[24],"This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.",[98,146,147,30],"ALK","Stage I",[98,149,150,151],"ALK positive","adjuvant treatment","high-risk factors","2025-01-10",{"date":154,"type":35},"2025-01-13",{"date":156,"type":21},"2025-03-15",{"date":158,"type":21},"2032-03-31",{"name":160,"class":42},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":4},"100496314","adjuvant-treatment-of-digestive-tract-tumors-100496314","NCT05742620","Adjuvant Treatment of Digestive Tract Tumors","Follow-up and Registration Study of Anlotinib Combined With Adjuvant Chemotherapy in the Treatment of Locally Advanced Gastrointestinal Tumors","ATDTT","Inclusion Criteria:\n\n* 1.18 years old ≤ age ≤ 75 years old, male or female;\n* 2\\. ECOG score 0\\~2 points;\n* 3\\. Patients with locally advanced gastric cancer and colorectal cancer after radical surgery (R0 resection);\n* 4\\. Gastric cancer: patients with stage III (pT1N3bM0, pT2N3M0, pT3N2-3M0, pT4aN1-3M0, pT4bN0-3M0);\n* 5\\. Colorectal cancer: patients with stage III (T any N+M0);\n* 6\\. Normal function of main organs\n* 7\\. Female subjects of childbearing age must carry out a serum pregnancy test within 3 days before starting the study medication, and the result is negative, and are willing to use a medically approved effective contraceptive measure (such as intrauterine device, contraceptive or condom) during the study period and within 3 months after the last administration of the study medication; For male subjects whose partners are women of childbearing age, they should undergo surgical sterilization or agree to use effective methods of contraception during the study and within 3 months after the last study administration.\n* 8\\. Subjects voluntarily joined the study and signed the informed consent form, with good compliance and cooperation in follow-up.\n\nExclusion Criteria:\n\n* 1\\. Postoperative distal metastasis or failure to achieve R0 resection;\n* 2\\. Have experienced any anti-tumor treatment before surgery, including chemotherapy, radiotherapy and targeted drug treatment;\n* 3\\. Patients with contraindications to chemotherapy;\n* 4\\. Other malignant tumors in the past 3 years;\n* 5\\. Clinically obvious bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood++or above the baseline, or vasculitis);\n* 6\\. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite the best drug treatment);\n* 7\\. People newly diagnosed with angina pectoris within 3 months before screening or suffering from serious cardiovascular diseases within 6 months before screening, including unstable angina pectoris or myocardial infarction; Arrhythmias (including QTcF: male ≥ 450 ms, female ≥ 470 ms) require long-term use of antiarrhythmic drugs; ≥ Grade 2 congestive heart failure (NYHA classification);\n* 8\\. Severe infection (such as the need for intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening\u002Fbefore the first administration\\>38.5 ° C;\n* 9\\. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* 10\\. Pregnant or lactating women; Those with fertility who are unwilling or unable to take effective contraceptive measures;\n* 11\\. It is known that it will produce allergy, hypersensitivity or intolerance to the test drug and its excipients;\n* 12\\. Subjects who are participating in other clinical studies or whose first medication is less than 4 weeks from the end of the previous clinical study (the last medication), or who have 5 half-lives of the study drug;\n* 13\\. Subjects are known to have a history of abuse of psychotropic substances, alcohol or drug abuse;\n* 14\\. The researcher believes that there are any conditions that may harm the subject or cause the subject to fail to meet or perform the research requirements.",{"count":170,"type":21},100,[172],"NA","To evaluate the 3-year Disease-free survival rate(DFSR) of patients with locally advanced gastric cancer and colorectal cancer treated with anlotinib combined with adjuvant chemotherapy.",[30],"2023-02-15",{"date":177,"type":35},"2023-02-24",{"date":179,"type":21},"2023-06-20",{"date":181,"type":21},"2029-07-20",{"name":183,"class":42},"Xijing Hospital"]