[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mpr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mpr":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100589024","phase-3-neoadjuvant-cadonilimab-combined-with-perioperative-oxaliplatin-plus-s1-for-diffuse-or-mixed-type-of-locally-advanced-gastricgastroesophageal-junction-adenocarcinoma-100589024",false,"NCT06949033","Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Type of Participant and Disease Characteristics\n\n   1. Patients must have a pathologically confirmed diagnosis of HER-2 negative tumor and diffuse or mixed type gastric or gastroesophageal junction adenocarcinoma according to Lauren's histological subtypes.\n   2. Patients must have previously untreated locally advanced gastric or gastroesophageal junction adenocarcinoma (stage cT2, cT3, cT4), with lymph nodes ranging from N1 to N3 and no evidence of metastatic disease (M0).\n   3. Patients with Siewert type 2 or 3 tumors are eligible. Enrollment of participants with Siewert type 1 tumors will be limited to those for whom the planned treatment is perioperative chemotherapy and resection.\n2. Demographics\n\n   1. Male or female subjects must be between the ages of ≥ 18 and ≤ 75 years at the time of signing the informed consent.\n   2. Expected Survival: The expected survival time must be ≥ 12 weeks.\n   3. Performance Status: Subjects must have an ECOG performance status of 0 or 1 (refer to Appendix 1).\n   4. Male Contraception: Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception from Day 1 through 120 days after receipt of the final dose of the investigational product. It is strongly recommended for the female partner of a male subject to also use an effective method of contraception throughout this period.\n   5. Female subjects of childbearing potential must be willing to use adequate contraception methods throughout the study and for 120 days after the last dose of the study drug. The decision to discontinue contraception after this time point should be discussed with the attending physician. Periodic abstinence, contraceptive rhythm methods, and withdrawal are not acceptable forms of contraception.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n      * Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n      * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n3. Organ Function\n\n   1. Blood Routine (no blood transfusion within 14 days): WBC ≥ 3.0 × 10\\^9\u002FL; ANC ≥ 1.5 × 10\\^9\u002FL; PLT ≥ 100 × 10\\^9\u002FL; HGB ≥ 80 g\u002FL.\n   2. Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT\u002FAST levels ≤ 2.5 × ULN.\n   3. Renal Function: Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL\u002Fmin for those with Cr \\> 1.5 × ULN.\n   4. Coagulation Function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.\n   5. Cardiac Function: Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n      * Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n      * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n4. Informed Consent All subjects must provide written informed consent to participate in the study.\n5. Other Inclusions\n\n   1. Prior Treatment: Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n   2. Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.\n   3. Be willing to provide tissue and blood sample from a tumor lesion at baseline and at time of surgery\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n   2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years (except for cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ that has undergone potentially curative therapy).\n   3. Has an active infection requiring systemic therapy.\n   4. Has an active autoimmune disease that has required systemic treatment in the past 2 years. (NOTE: Subjects with vitiligo, alopecia, Grave's disease, Type I diabetes mellitus, hypothyroidism (e.g., following Hashimoto's syndrome) only requiring hormone replacement on a stable dose (without adjustment in the first 4 weeks of study treatment), psoriasis or eczema not requiring systemic treatment (within the past 2 years), or conditions not expected to recur in the absence of an external trigger are not excluded.)\n   5. Has any complications requiring systemic treatment with corticosteroids such as prednisone (\\> 10mg\u002Fday) or other immunosuppressive medications within 14 days prior to the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n   6. History of primary immunodeficiency.\n   7. Has received a live vaccine or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin, or immunotherapy) within 30 days prior to the first dose of study treatment.\n   8. Has a known history of active tuberculosis.\n\n      * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n   9. Has a known severe allergy or hypersensitivity to cadonilimab or sintilimab or any of the study chemotherapy agents and\u002For to any of their excipients.\n   10. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:\n\n       * Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 480 ms), grade III or IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) \\\u003C 50.0% as determined by color Doppler echocardiography.\n       * Cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombotic, embolic, or ischemic events.\n2. Prior\u002FConcomitant Therapy\n\n   1. Subjects who have already enrolled in another clinical study, unless it is an observational, non-interventional clinical study, or they are in the follow-up period for an interventional study (the time between the first dose of cadonilimab and the last dose in the previous clinical study should be more than 4 weeks or 5 times the half-life of the previous study drug).\n   2. Subjects who have received any systemic or curative anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy.\n   3. Subjects who have previously received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.).\n3. Other exclusion criteria\n\n   1. Confirmed HER-2 positive tumor will be excluded.\n   2. Patients could not provide tumor samples and blood samples.\n   3. Pregnant or lactating patients, as well as patients with childbearing potential who plan to be pregnant within 5 months after the study; Women of childbearing should receive a blood pregnancy test within 7 days before the study","ALL","18 Years","75 Years",{"count":19,"type":20},668,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. The main questions it seeks to answer are:\n\n1. Is neoadjuvant cadonilimab plus SOX chemotherapy superior to neoadjuvant placebo plus SOX chemotherapy in terms of the pathological complete response (pCR) rate at the time of surgery?\n2. To evaluate and compare the 3-year OS rate in patients receiving neoadjuvant cadonilimab plus SOX chemotherapy versus patients receiving placebo plus neoadjuvant SOX chemotherapy regimen.\n\nParticipants will be divided into two groups:\n\n1. Experimental group: Participants will receive intravenous cadonilimab (10 mg\u002Fkg) in combination with the SOX regimen (oxaliplatin 130 mg\u002Fm² and S-1, with the initial dose determined based on body surface area).\n2. Control group: Participants will receive a placebo in combination with the SOX regimen.\n\nAfter completing 3-4 cycles of treatment, patients in both the experimental and control groups will undergo radical surgery with D2 or D2+ lymphadenectomy. Following surgery, patients will receive 4 cycles of adjuvant SOX chemotherapy at 70% of the standard dosage, administered every 21 days, starting within 3-6 weeks post-surgery.",[26,27,28,29,30,31],"Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])","Neoadjuvant Therapy","Adjuvant Chemotherapy","pCR Rate","MPR","ORR,OS,PFS",[33,34,35,36,37],"gastric cancer","Diffuse or Mixed type","Cadonilimab","Oxaliplatin","S1","RECRUITING","2025-07-03",{"date":41,"type":42},"2025-07-10","ACTUAL",{"date":44,"type":42},"2025-05-15",{"date":46,"type":20},"2030-12-31",{"name":48,"class":49},"Zuoyi Jiao","OTHER",4,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":75,"locationsCount":50},"100587196","phase-3-neoadjuvant-apatinib-combined-with-sintilimab-and-perioperative-sox-versus-neoadjuvant-sintilimab-combined-with-perioperative-sox-for-intestinal-type-of-locally-advanced-gastricgastroesophageal-junction-adenocarcinoma-100587196","NCT06925243","Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Open-Label, Randomized Controlled Phase III Study","Inclusion Criteria:\n\n1. Type of Participant and Disease Characteristics\n\n   1. Patients must have a pathologically confirmed diagnosis of HER-2 negative tumor and intestinal type gastric or gastroesophageal junction adenocarcinoma according to Lauren's histological subtypes.\n   2. Patients must have previously untreated locally advanced gastric or gastroesophageal junction adenocarcinoma (stage cT2 to cT4), with lymph nodes ranging from N0 to N3 and no evidence of metastatic disease (M0).\n   3. Patients with Siewert type 2 or 3 tumors are eligible. Enrollment of participants with Siewert type 1 tumors will be limited to those for whom the planned treatment is perioperative chemotherapy and resection.\n2. Demographics\n\n   1. Male or female subjects must be between the ages of ≥ 18 and ≤ 75 years at the time of signing the informed consent.\n   2. Expected Survival: The expected survival time must be ≥ 12 weeks.\n   3. Performance Status: Subjects must have an ECOG performance status of 0 or 1.\n   4. Male Contraception: Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use an effective method of contraception from Day 1 through 120 days after receipt of the final dose of the investigational product. It is strongly recommended for the female partner of a male subject to also use an effective method of contraception throughout this period.\n   5. Female subjects of childbearing potential must be willing to use adequate contraception methods throughout the study and for 120 days after the last dose of the study drug. The decision to discontinue contraception after this time point should be discussed with the attending physician. Periodic abstinence, contraceptive rhythm methods, and withdrawal are not acceptable forms of contraception.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n\n   ii.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n   * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n3. Organ Function\n\n   1. Blood Routine (no blood transfusion within 14 days): WBC ≥ 3.0 × 10\\^9\u002FL; ANC ≥ 1.5 × 10\\^9\u002FL; PLT ≥ 100 × 10\\^9\u002FL; HGB ≥ 80 g\u002FL.\n   2. Hepatic Function: Total bilirubin (TBIL) ≤ 1.5 × ULN, or direct bilirubin ≤ ULN for those with total bilirubin levels 1.5 × ULN and ALT\u002FAST levels ≤ 2.5 × ULN.\n   3. Renal Function: Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL\u002Fmin for those with Cr \\> 1.5 × ULN.\n   4. Coagulation Function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.\n   5. Cardiac Function: Cardiac function will be assessed using electrocardiogram and color Doppler ultrasound, and subjects must have had no myocardial infarction within the last six months. Hypertension and other coronary heart diseases must be controllable.\n\n      * Females of childbearing potential are defined as those who are not surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n      * Highly effective contraception methods, resulting in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, are required. Acceptable methods include a combination of a hormonal method (e.g., contraceptive pill) and a barrier method (e.g., male condom plus spermicide) to prevent pregnancy.\n      * Barrier methods include male condom plus spermicide, copper T intrauterine device, and levonorgestrel-releasing intrauterine system.\n\n   iv.Hormonal methods include implants, hormone injection, combined pill, minipill, and patch.\n   * If a female subject becomes pregnant or suspects pregnancy during her participation in the study or her partner's participation, she must promptly inform her treating physician.\n4. Informed Consent All subjects must provide written informed consent to participate in the study.\n5. Other Inclusions\n\n   1. Prior Treatment: Patients must not have previously received any anti-tumor treatments, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n   2. Plan to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice.\n\nBe willing to provide tissue and blood sample from a tumor lesion at baseline and at time of surgery\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n   2. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years (except for cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in situ that has undergone potentially curative therapy).\n   3. Has an active infection requiring systemic therapy.\n   4. Has an active autoimmune disease that has required systemic treatment in the past 2 years. (NOTE: Subjects with vitiligo, alopecia, Grave's disease, Type I diabetes mellitus, hypothyroidism (e.g., following Hashimoto's syndrome) only requiring hormone replacement on a stable dose (without adjustment in the first 4 weeks of study treatment), psoriasis or eczema not requiring systemic treatment (within the past 2 years), or conditions not expected to recur in the absence of an external trigger are not excluded.)\n   5. Has any complications requiring systemic treatment with corticosteroids such as prednisone (\\> 10mg\u002Fday) or other immunosuppressive medications within 14 days prior to the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.\n   6. History of primary immunodeficiency.\n   7. Has received a live vaccine or other immune-activating anti-tumor drugs (such as interferon, interleukin, thymosin, or immunotherapy) within 30 days prior to the first dose of study treatment.\n   8. Has a known history of active tuberculosis.\n   9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n   10. Has a known severe allergy or hypersensitivity to sintilimab or apatinib or any of the study chemotherapy agents and\u002For to any of their excipients.\n   11. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:\n\n       * Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥ 480 ms), grade III or IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) \\\u003C 50.0% as determined by ultrasonic cardiography.\n       * Cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombotic, embolic, or ischemic events.\n2. Prior\u002FConcomitant Therapy\n\n   1. Subjects who have already enrolled in another clinical study, unless it is an observational, non-interventional clinical study, or they are in the follow-up period for an interventional study.\n   2. Subjects who have received any systemic or curative anti-tumor therapy, including radiotherapy, chemotherapy, targeted therapy.\n   3. Subjects who have previously received any anti-PD-1, anti-PD-L1 antibody, or any other antibody or drug therapy targeting T-cell co-stimulation or checkpoint pathway, e.g. ICOS or agonists (e.g., CD40, CD137, GITR, and OX40, etc.).\n3. Other exclusion criteria\n\n   1. Confirmed HER-2 positive tumor will be excluded.\n   2. Patients could not provide tumor samples and blood samples.\n   3. Pregnant or lactating patients, as well as patients with childbearing potential who plan to be pregnant within 5 months after the study; Women of childbearing should receive a blood pregnancy test within 7 days before the study.",{"count":59,"type":20},682,[23],"This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer\u002Fgastroesophageal junction adenocarcinoma. The primary questions include:\n\n1. Whether the complete remission rate (pCR) of the apatinib combined with sintilimab and SOX regimen is higher than that of the sintilimab combined with SOX regimen.\n2. The safety of the apatinib combined with sintilimab and SOX regimen.\n\nParticipants will be divided into:\n\n1. Experimental Group: Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg\u002Fm² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles.\n2. Control Group: Participants will receive treatment with the sintilimab combined with the SOX regimen.\n\nThis treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Surgery is scheduled four weeks after the last neoadjuvant therapy (NAT) cycle. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks.",[26,27,28,29,30,31],[64,65,66,67,33,68],"apatinib","sintilimab","SOX","Neoadjuvant therapy","intestinal type","2025-04-21",{"date":71,"type":42},"2025-04-22",{"date":73,"type":42},"2025-04-15",{"date":46,"type":20},{"name":48,"class":49},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100576460","phase-4-efficacy-and-safety-of-ensartinib-in-neoadjuvant-therapy-for-stage-iia---iiib-operable-or-potentially-operable-alk-positive-lung-adenocarcinoma-a-multicenter-real-world-clinical-study-100576460","NCT06785584","Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study","Inclusion Criteria:\n\n* Age ≥18\n* Histologically or cytologically confirmed lung adenocarcinoma\n* Evaluated resectable TNM stage IIA-IIIB (operable or potentially operable) non-small cell lung cancer (NSCLC)\n* Alk-positive as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods，before treatment with ALK inhibitors\n* Measurable lesions were determined with the use of the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria) on CT scans\n* Magnetic resonance imaging (MRI) or CT scans of the brain show no metastatic disease\n* Tumors contained components of squamous cell carcinoma, large-cell neuroendocrine carcinoma, or small-cell carcinoma\n* Severe infections, including COVID-19, including but not limited to hospitalization due to complications of infection within the 4 weeks prior to starting study treatment\n* Have not received chemotherapy, radiotherapy, or biological therapy\n* Hemoglobin ≥100 g\u002FL(which can be maintained or exceeded by blood transfusion); Absolute neutrophil count ≥2.0×109\u002FL; Platelet count ≥100×109\u002FL\n* Total bilirubin ≤1.5 times upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; CREA ≤1.5 times the upper limit of normal and CREA clearance ≥60mL\u002Fmin\n* Women of childbearing age (15 to 49 years) must undergo a urine pregnancy test within 7 days before starting treatment and the result is negative\n* Informed consent is obtained from patients or their legal representatives\n* Able to swallow oral medications normally\n* ECOG behavior status score is 0 to 1\n* Men and women of reproductive age agree to use a reliable method of contraception before entering the trial, during the study and up to eight weeks after discontinuation\n* Stable health status, including no acute exacerbations of chronic diseases, serious infections, or major surgeries during the first 4 weeks of enrollment, as indicated in other inclusion\u002Fexclusion criteria\n\nExclusion Criteria:\n\n* Have received any systemic anti-cancer treatment for locally advanced non-small cell lung cancer, including chemotherapy, biotherapy (including ALK-TKI), immunotherapy, or any investigational drug\n* PET-CT scan or biopsy results showing unresectable stage III and IV disease with distant metastasis (including malignant pleural effusion)\n* Patients who had a cancer other than NSCLC within 5 years before the initiation of study treatment\n* Allergy to ensartinib or any of the ingredients in this product\n* Previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;Baseline CT scans found idiopathic pulmonary fibrosis\n* Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow preparations, or previous major bowel resection resulting in inadequate absorption of ensartinib\n* Any unstable systemic illness, including active infection, uncontrolled hypertension, unstable angina, angina with onset within the last 3 months, congestive heart failure (≥ New York Heart Association \\[NYHA\\] class II), myocardial infarction (within 6 months before enrollment), severe arrhythmias requiring medical therapy, or hepatic, renal, or metabolic disease\n* Human immunodeficiency virus (HIV) infection\n* Pregnant or lactating women\n* A definite past history of neurological or psychiatric disorders, including epilepsy or dementia\n* History of organ transplantation\n* Rheumatic immune-related diseases\n* Other cases that the researcher deemed unsuitable for enrollment",{"count":83,"type":20},30,[85],"PHASE4","According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer.\n\nSurgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients.\n\nIn the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients.\n\nMany studies have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC.\n\nThe investigators designed this study to explore the efficacy of enshatinib neoadjuvant therapy in patients with stage IIA to III ALK-positive lung adenocarcinoma",[88,89,30,27],"ALK-positive Advanced NSCLC","ALK-positive Non-small Cell Lung Cancer (NSCLC)",[91,27,92,30],"Ensartinib","ALK-Positive Lung Adenocarcinoma","NOT_YET_RECRUITING","2025-01-19",{"date":96,"type":42},"2025-01-21",{"date":98,"type":20},"2025-02-01",{"date":100,"type":20},"2025-12-01",{"name":102,"class":49},"Fujian Medical University Union Hospital",1]