[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anlotinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anlotinib":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,44,71,98,122,146,172],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":43},"100599800","phase-2-tislelizumab-combined-with-anlotinib-and-nab-paclitaxel-in-iii-resectable-non-small-cell-lung-cancer--a-prospective-single-arm-phase-ii-study-100599800",false,"NCT07089199","Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study","TitAN","Inclusion Criteria:\n\n1. Age 18-75 years old, gender is not limited;\n2. Histologically confirmed Stage III non-small cell lung cancer (AJCC Stage 8th edition)\n3. The tumor is resectable after assessment by the attending surgeon\n4. EGFR\u002FALK mutation negative or unknown (unknown only for squamous non-small cell lung cancer)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. No previous treatment received\n7. At least 1 measurable lesion as defined by RECIST v1.1\n8. Be able to provide the Informed Consent Form (ICF), and be able to understand and agree to abide by the research requirements and assessment schedule\n9. Good organ function; • Patients have not received blood transfusion or growth factor support therapy ≤ 14 days prior to sample collection during the screening period and: Absolute neutral cell count (ANC) ≥1.5 x 109\u002FL Platelet ≥100 x 109\u002FL Hemoglobin ≥90 g\u002FL • Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) creatinine clearance ≥ 45 mL\u002Fmin Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert\\'s syndrome must have total bilirubin \\< 3 × ULN) AST and ALT≤ 2.5 x ULN Patients who did not receive anticoagulant therapy: International standardized ratio or activated partial thromboplastin time ≤ 1.5 × ULN\n10. Women of childbearing age must take a serum pregnancy test within 3 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must agree to use highly effective methods of contraception during the study period and for 120 days after the last dose of the study drug\n\nExclusion Criteria:\n\n1. A history of received treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.\n2. Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, but if patients with squamous non-small cell lung cancer, the EGFR mutation status and ALK mutation status are unknown, it is not required to conduct tests during screening\n3. There are multiple factors influencing patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction)\n4. Allergy to any study drug (Tislelizumab, Anlotinib, albumin-bound Paclitaxel) or excipients.\n5. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor invasion of important blood vessels during treatment is likely to cause fatal bleeding.\n6. Clinically significant hemoptysis (more than 50 ml per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above baseline, or suffering from vasculitis, etc.).\n7. Vaccination with attenuated live vaccines within 4 weeks before the first dose or planned vaccination during the study period.\n8. Patients who are expected to be unable to tolerate surgery, such as those with cardiopulmonary insufficiency.\n9. Occurrence of or concurrent other malignancies within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\\].\n10. Patients with active viral hepatitis requiring treatment as determined by the investigator.\n11. Active autoimmune diseases requiring systemic treatment, or long-term use of high doses of steroids or other immunomodulators, which the investigator assesses as affecting the study treatment.\n12. Unhealed surgical incisions before the start of study treatment (small biopsy incisions can be included).\n13. Active hepatitis B\u002FC infection and human immunodeficiency virus (HIV) infection.\n14. Arterial or venous thrombotic events within 6 months (such as cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) or severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, uncontrolled arrhythmias; heart failure above grade III-IV according to NYHA standards, or left ventricular ejection fraction (LVEF) \\\u003C 50% as indicated by echocardiography.\n15. Interstitial lung disease, uncontrolled systemic medical history, including diabetes, hypertension, acute lung disease, etc.\n16. Active bleeding or coagulation dysfunction (INR \\> 2.0, PT \\> 16s), bleeding tendency or receiving thrombolytic, anticoagulant, antiplatelet therapy; any major surgery requiring general anesthesia within ≤ 28 days before the first dose.\n17. Underlying medical conditions or alcohol\u002Fdrug abuse that are unfavorable for the administration of study drugs, may affect the interpretation of results, or pose a high risk of treatment complications.","ALL","18 Years","75 Years",{"count":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.",[27,28,29,30],"NSCLC","Tislelizumab","Anlotinib","Nab-paclitaxel","RECRUITING","2026-06-11",{"date":34,"type":35},"2026-06-15","ACTUAL",{"date":37,"type":35},"2025-07-25",{"date":39,"type":21},"2028-07-10",{"name":41,"class":42},"Qilu Hospital of Shandong University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100452168","phase-2-preoperative-imrt-with-anlotinib-and-penpulimab-for-localized-sarcoma-spare-01-100452168","NCT05167994","Preoperative IMRT With Anlotinib and Penpulimab for Localized Sarcoma （SPARE-01）","Preoperative Intensity-Modulated Radiotherapy (IMRT) Combined With Concurrent Anlotinib Hydrochloride and Penpulimab for Localized Extremity or Trunk Sarcoma","SPARE-01","Inclusion Criteria:\n\n* Age older than 18-yo\n* Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.\n* ECOG 0-3\n* Histology reviewed by reference pathologist\n* Lesion can be assessed\n* Can tolerate radiotherapy and Anlotinib\n* Agree contraception.\n* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed\n\nExclusion Criteria:\n\n* No gross tumor post-resection in other center.\n* Contraindications to Anlotinib, including allergic to Anlotinb, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.\n* Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.\n* Benign histology\n* Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)\n* STS can be cured by extensive operation alone.\n* Previous irradiation to the same area\n* Radiological evidence of distant metastases\n* Other contraindications, can't tolerate operation or other treatment needed in this study.\n* Neoadjuvant chemotherapy given or planned.",{"count":53,"type":21},30,[24],"To investigate the safety and efficacy of preoperative IMRT and concurrent Anlotinib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Anlotinib Hydrochloride and Penpulimab for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.",[57,58,59,29,60,61],"Sarcoma,Soft Tissue","Extremity","Trunk","Intensity-modulated Radiotherapy","Major Wound Complications","2026-06-03",{"date":64,"type":35},"2026-06-04",{"date":66,"type":35},"2020-05-01",{"date":68,"type":21},"2027-12-31",{"name":70,"class":42},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100634291","phase-2-benmelstobart-plus-anlotinib-combined-with-sbrt-for-patients-with-hepatocellular-carcinoma-failing-first-line-targeted-therapy-100634291","NCT07537777","Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy","Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted Therapy:A Single-Arm, Multicenter Clinical Study","Inclusion Criteria:\n\n1. The patients voluntarily participated in the study, signed the informed consent form, and the compliance was good.\n2. Age \\>=18 years old, male or female;\n3. Patients with histologically confirmed or clinically diagnosed HCC, and the disease is not suitable for radical surgery;\n4. Patients with oligometastatic HCC who had failed previous target-immunotherapy combined with first-line therapy. Oligometastases are defined as the number of metastatic organs ≤2 and the total number of metastases \\\u003C=5, and oligometastases are suitable for SBRT treatment.\n5. Child-Pugh liver function score \\\u003C=7;\n6. ECOG score of 0-1;\n7. Expected survival time before initiation of study drug \\>=12 weeks;\n8. At least one measurable lesion (the long diameter of the measurable lesion on enhanced spiral CT or enhanced MR Scan \\>=10mm or the short diameter of the enlarged lymph node \\>=15mm according to RECISTv1.1; a lesion that has been treated with previous radiotherapy can be considered as a target lesion after definite progression according to RECISTv1.1 criteria);\n9. The following laboratory tests performed within 7 days before the first dose of medication confirmed that the patient's bone marrow, liver and kidney function met the following requirements for study participation: 1) hemoglobin \\>=80 g\u002FL (which can be maintained or exceeded by transfusion); 2) absolute neutrophil count (ANC) \\>=1.5×10\\^9; 3) platelet count \\>=50×10\\^9\u002Fmm3; 4) Total bilirubin \\\u003C=1.5 times upper limit of normal; 5) alanine aminotransferase and aspartate aminotransferase \\\u003C=2.5 times upper limit of normal (ULN); 6) creatinine \\\u003C=1.5 times upper limit of normal (ULN); And creatinine clearance \\>=60ml\u002Fmin; 7) international normalized ratio (INR) of prothrombin time \\\u003C=1.5 in patients without previous anticoagulant therapy; Partial thromboplastin time (APTT)\\\u003C=1.5 times the upper limit of normal; 8) if HBV-DNA is detectable, antiviral therapy should be started before enrollment; 9) If HCV-RNA is detectable, antiviral therapy should be started before enrollment.\n10. Women of childbearing age: must agree to abstain from sexual intercourse (heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the time of written informed consent until the last dose of study drug is administered. A serum HCG test had to be negative within 7 days before starting study treatment; And they must be non-lactating. Women were considered to be fertile if they had menstruated, had not yet reached a postmenopausal state (\\>=12 months of continuous absence of menses, with no cause other than menopause identified), and had not undergone sterilization procedures (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).\n11. Male patients whose partner was a woman of reproductive age had to agree to abstain from sex or to use a reliable, effective method of contraception for at least 120 days from the time of written informed consent until the last dose of study drug was administered. Male patients also had to agree not to donate sperm during the same period. Male subjects whose partner was pregnant were required to use condoms.\n\nExclusion Criteria:\n\n1. Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar cell carcinoma. Other active malignant tumors other than HCC within 5 years or at the same time. The cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., were excluded.\n2. Prior receipt of anlotinib or a non-PD-1 monoclonal antibody immune checkpoint inhibitor;\n3. The time interval between the last target-free drug use and enrollment was less than 3 weeks.\n4. Patients who received previous local treatment (including TACE, ablation, HAIC, or radiotherapy) for the target lesion less than 1 month before enrollment.\n5. Patients preparing for or previously receiving organ or allogeneic bone marrow transplantation;\n6. Moderate or severe ascites with clinical symptoms, which required therapeutic puncture, drainage or Child-Pugh score \\>2 (except for patients with small amount of ascites on imaging but without clinical symptoms); Uncontrolled or moderate or above amount of pleural effusion and pericardial effusion;\n7. A history of gastrointestinal bleeding within 6 months before the initiation of study treatment or a definite tendency for gastrointestinal bleeding, such as: Patients with risk of bleeding or severe esophagogastric varices, local active gastrointestinal ulcer lesions, and persistent positive fecal occult blood were excluded (patients with positive fecal occult blood at baseline could be re-examined, and patients with positive fecal occult blood after re-examination required gastroduodenoscopy (EGD). Patients with esophagogastric varices with a risk of bleeding were excluded).\n8. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before study treatment;\n9. Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in hemophilia patients;\n10. Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin was allowed);\n11. Currently using or recently using (within 10 days before initiation of study treatment) aspirin (\\> 325 mg\u002F day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment;\n12. There are not well controlled cardiac clinical symptoms or diseases, such as: (1) according to the New York Heart Association (NYHA) criteria (see Annex 5) grade II or higher cardiac dysfunction or cardiac ultrasound examination: Left ventricular ejection fraction (LVEF) \\\u003C50% (2) unstable heartache (3) myocardial infarction within 1 year before study treatment (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc \\> 450ms (male); QTc \\> 470ms (female) (QTc interval was calculated with Fridericia's formula; if QTc was abnormal, three consecutive tests could be performed at a 2-minute interval, and the mean value was calculated);\n13. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure \\>=140 mmHg or diastolic blood pressure ≥90 mmHg) (based on the mean of \\>=2 readings), and the use of antihypertensive treatment to achieve these parameters is permitted; A history of hypertensive crisis or hypertensive encephalopathy;\n14. Major vascular disease within 6 months before starting study treatment (e.g., aortic aneurysm requiring manual repair or recent peripheral artery thrombosis);\n15. Severe, unhealed or dehiscence wounds and active ulcers or untreated bone fractures;\n16. Major surgery (other than diagnosis) within 4 weeks before the start of study treatment or anticipated need for major surgery during the study;\n17. Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption;\n18. Had intestinal obstruction and\u002For had clinical signs or symptoms of GI obstruction within 6 months before starting study treatment, including incomplete obstruction related to a preexisting disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding: Patients with incomplete obstruction\u002Fobstruction syndrome\u002Fintestinal obstruction signs\u002Fsymptoms at initial diagnosis were allowed to enroll if definitive (surgical) treatment was given to resolve the symptoms;\n19. Evidence of pneumoperitoneum that could not be explained by paracentesis or recent surgical procedures;\n20. Metastatic disease involving a major airway or blood vessel (e.g., complete occlusion of the main portal vein or vena cava due to tumor invasion, which was defined as the confluence of the splenic vein and the superior mesenteric vein or the branch of the hepatic portal vein into left and right branches) or a centrally located large mediastinal tumor mass (\\\u003C30mm from the carinal crest) were excluded. The liver lesions were more than 50% occupied.\n21. The patient presented with active symptomatic central nervous system metastases or hepatic encephalopathy;\n22. Those who have had or are currently having interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., Bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia or severe impairment of lung function on chest computed tomography (CT) during the screening period were allowed to have radiation pneumonia in the radiation field. Active tuberculosis;\n23. Have active autoimmune disease or a history of autoimmune disease with possible recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism \\[subjects controlled only with hormone replacement therapy are eligible\\]); Subjects with skin diseases without systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely relieved in childhood and without any intervention in adulthood were included. Patients with asthma who required medical intervention with bronchodilators were excluded.\n24. Use of immunosuppressive or systemic hormonal therapy for immunosuppression within 14 days prior to initiation of study treatment (at a dose of \\>10mg\u002F day of prednisone or other equivalent);\n25. Use of strong CYP3A4\u002F CYP2C19 inducers including rifampicin (and its analogues) and St. John's ST. or strong CYP3A4\u002F CYP2C19 inhibitors within 14 days before starting study treatment;\n26. Known to have a history of severe allergy to any monoclonal antibody or anti-angiogenesis targeted drugs;\n27. Severe infection within 4 weeks before starting study treatment, including, but not limited to, hospitalization for infection, bacteremia, or complications of severe pneumonia; Therapeutic oral or intravenous antibiotics within 2 weeks before starting study treatment (patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infection or exacerbations of chronic obstructive pulmonary disease were eligible);\n28. Patients with congenital or acquired immune deficiency (such as HIV infection);\n29. Patients who had received traditional Chinese medicine (TCM) with anti-tumor therapeutic effect less than two weeks before enrollment (TCM containing the following herbs, such as brucea javanica, Coix seed, lentinus edodes polysaccharide, cantharides, bui skin, Astragalus, Kushen, Wu Guteng, Chebulae, icaritin, etc.);\n30. Received live attenuated vaccine within 28 days before starting study treatment;\n31. Received other trial medication within 21 days before starting study treatment;\n32. Pregnant or lactating women;\n33. According to the investigator's judgment, the patient has other factors that may affect the study results or lead to the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the patient.",{"count":79,"type":21},29,[24],"This prospective, single-arm, multicenter Phase II clinical trial aims to evaluate the efficacy and safety of Benmelstobart plus anlotinib combined with SBRT in patients with oligometastatic hepatocellular carcinoma who have failed first-line targeted therapy. Key study questions include: What is the progression-free survival (PFS) for patients treated with this regimen? How do the objective response rate (ORR), disease control rate (DCR), and overall survival (OS) compare? What are the safety and tolerability profiles of the combination therapy? Eligible subjects (after signing informed consent) will receive anlotinib 10mg on days 1-14 every 3 weeks + Benmelstobart 1200mg on day 1 every 3 weeks + SBRT. Treatment cycles will be 3 weeks long, continuing until a protocol-specified treatment discontinuation event occurs. Following treatment completion, subjects will undergo post-treatment safety follow-up and survival monitoring, with tumor progression monitoring conducted post-treatment.",[83,84,85,86,29,87],"Hepatocellular Carcinoma (HCC)","First-line Targeted Therapy Failure","Oligometastatic Hepatocellular Carcinoma","Benmelstobart","SBRT","NOT_YET_RECRUITING","2026-04-13",{"date":91,"type":35},"2026-04-17",{"date":93,"type":21},"2026-04-20",{"date":95,"type":21},"2028-08-31",{"name":97,"class":42},"Nanfang Hospital, Southern Medical University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":43},"100569842","phase-2-neoadjuvant-therapy-of-targeted-immunotherapy-combined-with-chemotherapy-for-locally-advanced-hnscc-100569842","NCT06699498","Neoadjuvant Therapy of Targeted Immunotherapy Combined With Chemotherapy for Locally Advanced HNSCC","Phase II Clinical Study of Neoadjuvant Therapy With Benmelstobart Combined With Anlotinib and Chemotherapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Age 18-75 years old;\n* ECOG PS score of 0-1;\n* Pathologically confirmed, untreated patients with head and neck squamous cell carcinoma, classified as stage III, IVa according to AJCC (8th edition), including hypopharyngeal cancer, laryngeal cancer, and oral cancer;\n* Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug, or have undergone sterilization. For male participants, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last administration of the trial drug, or have undergone surgical sterilization;\n* Signed the informed consent form with their own consent and have good compliance.\n\nExclusion Criteria:\n\n* Received previous PD-1\u002FPD-L1\u002FCTLA-4 antibody therapy;\n* Tumor invasion of major blood vessels;\n* Patients requiring systemic use of glucocorticoids (\\>10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days before administration or during treatment. Inhaled or local use of steroids and adrenal corticosteroids at doses \\>10mg\u002Fday prednisone equivalent are allowed in the absence of active autoimmune diseases. Adrenal corticosteroid replacement therapy not exceeding 10mg\u002Fday prednisone equivalent is also allowed;\n* Presence of any history of active immune or autoimmune diseases, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Active or uncontrolled severe infection (≥NCI CTCAE v5.0 Grade 2 infection) within 4 weeks before enrollment;\n* Abnormal coagulation function (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds or APTT \\> 1.5 ULN), tendency to bleed, or receiving thrombolytic or anticoagulant therapy; Note: Small doses of heparin (adult daily dose of 6,000-12,000 U) or small doses of aspirin (daily dose ≤ 100 mg) for preventive purposes are allowed provided that the international normalized ratio of prothrombin time (INR) is ≤ 1.5;\n* Patients with imaging showing tumor invasion of vital perivascular tissue or whose tumor is likely to invade vital blood vessels during subsequent study and cause fatal bleeding as judged by the investigator;\n* Patients with any signs or history of bleeding diathesis, regardless of severity;\n* patients with any bleeding or hemorrhage event ≥ CTCAE Grade 2 within 4 weeks before enrollment, presence of unhealed wounds, ulcers, or fractures;\n\nAbnormalities in major organ functions:\n\n* Abnormal blood routine examination (received blood transfusion or blood products, or used G-CSF and other hematopoietic growth factors for correction within 14 days):\n\n  1. Hemoglobin (HB) \\\u003C 90g\u002FL;\n  2. Absolute neutrophil count (ANC) \\\u003C 1.5 × 109\u002FL;\n  3. Platelets (PLT) \\\u003C 100 × 109\u002FL;\n\n     * Abnormal biochemical examination:\n\n  \u003C!-- -->\n\n  1. Total bilirubin (TBIL) \\> 1.5 \\* upper limit of normal (ULN);\n  2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 × ULN;\n  3. Serum creatinine (Cr) \\> 1.5 × ULN or creatinine clearance rate (CCr) \\\u003C 60ml\u002Fmin; ③ Abnormal Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) \\\u003C normal lower limit (60%);\n\n     * Abnormal thyroid function: TSH \\> upper limit of normal (ULN) with abnormal T3 and T4 levels;\n\n       * Renal insufficiency: Urine routine test indicating urine protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g;\n       * Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480ms), and ≥ Grade 2 congestive heart failure (New York Heart Association (NYHA) classification) within 6 months before enrollment;\n       * Diagnosed with other malignancies within 3 years before enrollment;\n       * Patients with any severe and\u002For uncontrolled diseases, including:\n\n  \u003C!-- -->\n\n  1. Patients with uncontrolled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); Grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 430ms), and Grade I cardiac insufficiency (NYHA classification);\n  2. Active or uncontrolled severe infections;\n  3. Diseases such as cirrhosis, decompensated liver disease, active hepatitis HBV or HCV;\n  4. Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10mmol\u002FL);\n  5. Urine routine test indicating urine protein ≥ 2+, and confirmed 24-hour urine protein \\> 1.0g;\n\n     \\- Presence of long-term unhealed wounds or fractures;\n\n     \\- Pulmonary hemorrhage graded \\> 1 by NCI CTC AE V4.0 within 4 weeks before enrollment; hemorrhage in other locations graded \\> 2 by NCI CTC AE V4.0 within 4 weeks before enrollment; patients with a tendency to bleed (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy such as warfarin, heparin, or similar drugs;\n\n     \\- History of gastrointestinal perforation and\u002For fistula within 6 months before selected treatment; or history of arterial\u002Fvenous thrombotic events such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis, and pulmonary embolism;\n\n     \\- Imaging showing tumor invasion of vital blood vessels or patients whose tumor is likely to invade vital blood vessels and cause fatal bleeding during subsequent study as judged by the investigator;\n\n     \\- Clinically significant ascites, including any ascites detectable by physical examination, ascites that has been treated or still requires treatment, and patients with only a small amount of ascites shown by imaging but asymptomatic are eligible;\n\n     \\- Uncontrolled metabolic disorders or other non-malignant tumor organ or systemic diseases or secondary reactions to cancer that can lead to high medical risks and\u002For uncertainty in survival evaluation;\n\n     \\- Participated in other anti-cancer drug clinical trials within 4 weeks before enrollment;\n     * Patients with a history of psychotropic drug abuse who cannot quit or have mental disorders;\n     * Any accompanying diseases or other conditions that the investigator judges as seriously endangering the safety of the patient, potentially confusing the study results, or affecting the patient's completion of this study.",{"count":106,"type":21},45,[24],"Exploring the safety and effectiveness of neoadjuvant therapy using benmelstobart combined with anlotinib and chemotherapy for locally advanced squamous cell carcinoma of the head and neck patients.",[110,111,112,29],"Head and Neck Squamous Cell Carcinoma","Neoadjuvant Therapy","PD-L1","2024-11-19",{"date":115,"type":35},"2024-11-21",{"date":117,"type":21},"2024-12-03",{"date":119,"type":21},"2027-12-01",{"name":121,"class":42},"The First Affiliated Hospital with Nanjing Medical University",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":43},"100383864","phase-2-anlotinib-plus-toripalimab-as-first-line-treatment-for-advanced-gastric-cancer-with-ecog-2-apical-gc-100383864","NCT04278222","Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)","Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial","Inclusion Criteria:\n\n* Histologically confirmed, UICC stage IV gastric cancer;\n* no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;\n* at least one measurable lesion;\n* received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;\n* ECOG performance status 2;\n* the main organ function to meet the following criteria: HB ≥ 90g \u002F L, ANC ≥ 1.5 × 109 \u002F L, PLT ≥ 80 × 109 \u002F L,BIL \\\u003C1.5 times the upper limit of normal (ULN), ALT and AST \\\u003C2.5 × ULN and if liver metastases, BIL \\\u003C 3 × ULN, ALT and AST \\\u003C5 × ULN; Serum Cr ≤ 1.5 × ULN;\n* Patient's written declaration of consent obtained;\n* Estimated life expectancy \\> 3 months;\n\nExclusion Criteria:\n\n* harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;\n* dMMR\u002FMSI-H;\n* Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);\n* have received anlotinib or other immune checkpoint inhibitor ;\n* with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;\n* severe wounds or surgery 4 weeks before recruitment;\n* received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;\n* History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.\n* pregnancy or breast feeding;\n* absent or restricted legal capacity;\n* a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study",{"count":130,"type":21},24,[24],"This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.",[134,135,29,136],"Gastric Cancer","Immunotherapy","Toripalimab","2024-07-09",{"date":139,"type":35},"2024-07-10",{"date":141,"type":35},"2020-02-10",{"date":143,"type":21},"2024-12-31",{"name":145,"class":42},"Shanghai Changzheng Hospital",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100519804","phase-3-a-single-center-single-arm-clinical-study-on-the-treatment-of-advanced-non-small-cell-lung-cancer-with-positive-egfr-sensitive-mutations-and-failed-egfr-tkis-with-the-combination-of-enrotinib-and-paclitaxel-monoclonal-antibody-100519804","NCT06048315","A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody","A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell","Inclusion Criteria:\n\n* Volunteer to participate in clinical research, aged 18-75 years old, regardless of gender, and sign a written informed consent form.\n* According to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, locally advanced or metastatic (IIIB, IIIC, IV) NSCLC patients who are confirmed by histology or cytology to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy.\n* NSCLC patients who have tested positive for EGFR gene sensitive mutations through driver gene testing and have not undergone systematic treatment after EGFR TKI treatment failure.\n* Newly treated patients who have not received systemic radiotherapy and chemotherapy in the past, or patients who have relapsed after more than 6 months of follow-up after adjuvant chemotherapy after surgery.\n* At least one evaluable lesion judged according to RECIST criteria.\n* Men or women aged 18 years ≤ 75 years old.\n* ECOG PS 0 or 1.\n* The expected survival period is ≥ 12 weeks.\n* Adequate blood function: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL and platelet count ≥ 90 × 109\u002FL and hemoglobin ≥ 9 g\u002FdL.\n* Adequate liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value (ULN); AST and ALT ≤ 2.5 times the upper limit of normal value (ULN); Alkaline phosphatase ≤ 5 times the upper limit of normal value (ULN).\n* Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculated creatinine clearance rate ≥ 60 mL\u002Fmin.\n* Women of childbearing age must have negative pregnancy test results within 28 days prior to enrollment in the study (unless amenorrhea has occurred for 24 months). If the pregnancy test is more than 7 days after the first administration, a urine pregnancy test is required for validation (within 7 days before the first administration).\n* If there is a risk of conception, all patients (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component contained in the formulation of arotinib or piazepril monoclonal antibody;\n* Individuals who are intolerant to the treatment of investigational drugs or are known to be allergic to any investigational drug or its excipients.\n* Pregnant or lactating women, or female patients with fertility who have not taken contraceptive measures;\n* Existing severe acute infections that have not been controlled; Those who may have purulent or chronic infections, and the wound persists without healing;\n* Individuals with previously severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;\n* Those who suffer from uncontrollable neurological, mental disorders or mental disorders, have poor compliance, and are unable to cooperate and describe treatment responses; Patients with primary brain tumors or central nervous system metastases whose condition has not been controlled and who have obvious intracranial hypertension or neuropsychiatric symptoms;\n* Have coagulation dysfunction or bleeding tendency, or have a history of thrombotic or hemorrhagic diseases;\n* Those undergoing anticoagulation or thrombolysis treatment;\n* There are unhealed wounds, ulcers, or fractures;\n* Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;\n* Has undergone major surgical treatment (excluding surgery for biopsy purposes) within 4 weeks prior to the first study drug administration, or is expected to undergo major surgery during the study period;\n* Pulmonary interstitial fibrosis with respiratory failure;\n* Patients with chronic obstructive pulmonary disease and respiratory failure;\n* Based on chest imaging examination, sputum examination, and clinical examination, it is determined that there is active pulmonary tuberculosis (TB) infection;\n* Patients with active, known or suspected autoimmune diseases. Patients with hypothyroidism who only require hormone replacement therapy can be selected;\n* Patients who require systemic corticosteroids (with a dose equivalent to\\>10 mg prednisone\u002Fday) or other immunosuppressive drugs within the 14 days prior to enrollment. Patients who use inhaled or topical corticosteroids, as well as patients with adrenal corticosteroid replacement therapy doses equivalent to\\>10 mg prednisone\u002Fday, may participate in the study if there is no active autoimmune disease;\n* Previously received PD-1 or PD-L1 antibody treatment for any reason;\n* Suffering from other primary malignant tumors before the start of the study;\n* Other situations where the researcher believes that patients are not suitable to participate in this trial.",{"count":154,"type":21},52,[156],"PHASE3","Lung cancer is the second most common malignancy and mortality rate in the world. In the United States and Europe, approximately 10% to 15% of NSCLC patients have epidermal growth factor receptor (EGFR)-sensitive mutations, with higher mutation rates of 30% to 40% in Asia, and objective response rates (ORRs) of 76% to 80% with EGFR Tyrosine Kinase Inhibitor (TKI)-targeted therapy. However, resistance mechanisms such as EGFR, MET, PIK3CA and BRAF gene alterations occur with the development of resistance to EGFR-TKI therapy; Median Progression Free Survival (mPFS) for only 2.8-3.2 months; The median overall survival (mOS) is only 7.5-10.6 months. Due to the variety of mechanisms of resistance to EGFR-TKIs and the limited efficacy of chemotherapy, it is necessary to provide salvage treatment for advanced non-small cell lung cancer that is positive for EGFR-sensitive mutations and has failed EGFR TKIs.\n\nAnlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) used to inhibit tumor angiogenesis and proliferative signaling. The main targets of anlotinib include tyrosine kinase vascular endothelial growth factor receptor 1-3 (VEGFr1-3), fibroblast growth factor receptor 1-4 (Fibroblast Growth Factor Receptor 1-4), platelet-β derived growth factor receptor α and β, and stem cell factor receptor. Anlotinib is rapidly absorbed through the intestine, has high bioavailability, a half-life of 5 days, and is convenient for oral administration, which is conducive to improving patient dependence. IN MAY 2018, THE CHINA FOOD AND DRUG ADMINISTRATION APPROVED ANLOTINIB FOR MARKETING, ENTERED THE MEDICAL INSURANCE CATALOG IN OCTOBER OF THE SAME YEAR, AND WAS RECOMMENDED BY THE CHINESE SOCIETY OF CLINICAL ONCOLOGY (CSCO) FOR THE THIRD-LINE TREATMENT OF LUNG CANCER IN 2019.\n\nPenpulimab is a humanized immunoglobulin G1 monoclonal antibody (IgG1), which is a class 1 new drug jointly developed by Zhongshan Akeso Biopharmaceutical Co., Ltd. and Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1\u002FPD-L1 pathway that leads to tumor immune tolerance, and reactivating the anti-tumor activity of T lymphocytes to achieve the purpose of treating tumors. A number of preclinical in vitro trials have verified the effect of PEAMPLIMAB in blocking PD-1 pathway, and the results of preclinical pharmacodynamics, animal pharmacokinetics and toxicology have shown that PEAMPLIMAB has good stability, reduced host cell protein residues, and can effectively bind to antigens, and eliminate Fc-mediated effector function, with higher safety.\n\nAK105-201 is a multicenter, double-blind, randomized controlled, phase III clinical trial evaluating the efficacy and safety of pianpulimab combined with carboplatin + paclitaxel in the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer, the primary endpoint of the study was PFS, and the secondary endpoint was OS, and the results showed that the mPFS group of pianpulimab and the control group were 7.6m and 4.2m, respectively, and the HR was 0.44, reducing the risk of disease progression by 56%. In the 2022 CSCO guidelines for the diagnosis and treatment of non-small cell lung cancer, peamplimab combined with platinum-containing chemotherapy is recommended as the first-line treatment for stage IV driver-free squamous cell carcinoma Grade II. In advanced patients with EGFR TKIs resistance, pemetrexed chemotherapy has a good efficacy, with a median PFS of 2.83 months and a response rate of 22%. The AK105-203 study is a multicenter phase II clinical study led by Professors Jiao Shun and Bai Li of the Chinese PLA General Hospital of the People's Liberation Army of Anlotinib combined with péamplimab in the first-line treatment of hepatocellular carcinoma, with a median follow-up of 23 months and mPFS of 8.8 months.\n\nTherefore, based on the results of the current study on immunosuppressants and antiangiogenic drugs for the treatment of NSCLC, and the current research status in patients with advanced NSCLC who are positive for EGFR-sensitive mutations and have failed EGFR TKIs, we expect to conduct an exploratory clinical study of PD-1 antibody (péamplimab) combined with anlotinib in patients with advanced NSCLC who are positive for EGFR-sensitive mutations and have failed EGFR TKIs, with the aim of evaluating the safety of this combination, It was further investigated whether this combination could further improve the survival benefit of patients with advanced NSCLC.",[159,160,161,29,162],"Lung Cancer","TKI Resistance","EGFR Sensitive Mutation","Pianzumab","2023-09-15",{"date":165,"type":35},"2023-09-21",{"date":167,"type":21},"2023-09",{"date":169,"type":21},"2026-09",{"name":171,"class":42},"Degan Lu",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100499045","phase-2-safety-and-efficacy-of-aumolertinib-combined-with-anlotinib-as-1st-line-treatment-in-advanced-lung-cancer-egfr-mutation-with-tp53-co-mutation-100499045","NCT05778149","Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation","Inclusion Criteria:\n\n1. Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation;\n2. Age 18-85 years, male or female;\n3. Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered;\n4. ECOG 0-1, The expected survival is more than 6 months;\n5. At least one assessable lesion (RECIST 1.1 );\n6. If the main organs function normally, they meet the following standards:\n\n   1. Absolute value of neutrophils (ANC) ≥ 1.5 × 10 \\^ 9 \u002FL;\n   2. platelet count ≥ 100 × 10 \\^ 9 \u002FL\n   3. hemoglobin ≥ 90g \u002FL;\n   4. white blood cell ≥ 3.0 × 10\\^9\\\\\u002FL；\n   5. Liver function: total bilirubin\\\u003C1.5 times the upper limit of normal value, aspartate aminotransferase (AST \u002FSGOT), alanine aminotransferase (ALT \u002FSGPT) and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal value; In case of liver metastasis, AST and ALT ≤ 5.0 times the upper limit of normal value; In case of liver metastasis and\u002For bone metastasis, ALP ≤ 5.0 times the upper limit of normal value.\n   6. Renal function: serum creatinine (Scr) ≤ 1.5 times the upper limit of normal value; Urine routine test: urine protein\\\u003C2 (+); If the urine protein at baseline is ≥ 2 (+), the 24-hour urine protein quantity must be ≤ 1.0g;\n   7. Coagulation function: international normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal value;\n\nExclusion Criteria:\n\n1. Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); Small cell lung cancer (including small cell and non-small cell mixed lung cancer); Patients who have received systemic therapy in the past (allow to receive adjuvant or neoadjuvant therapy in the past);\n2. Patients with symptomatic brain metastasis at the beginning of treatment (patients with brain metastasis who have received treatment in the past are eligible if asymptomatic brain metastasis lasts for at least 4 weeks when receiving stable dose of drug treatment);\n3. . Patients who participated in the intervention tumor clinical trial during the first-line treatment or within the last 30 days before the first-line treatment;\n4. History of tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula and intra-abdominal abscess within 6 months before treatment;\n5. Suffer from serious cardio-cerebrovascular disease;\n6. Subjects who received chest radiotherapy in the lung field within the first 4 weeks, or who have not recovered from radiotherapy-related toxicity. Subjects who received radiotherapy or did not recover from radiotherapy-related toxicity within 2 weeks before randomization for all other anatomical sites;\n7. Major surgical treatment was performed within 4 weeks before treatment or planned during the trial period (the researcher judged that there was bleeding risk or wound healing complications);\n8. . Have bleeding tendency, high bleeding risk or coagulation dysfunction, including thrombotic disease within 6 months before randomization and\u002For hemoptysis history within 3 months before randomization (single cough bleeding ≥ 2.5mL)\n9. Subjects with high suspicion of idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia or active pneumonia on chest CT scan during screening period;\n10. Imaging examination showed that there was evidence of tumor invasion into large vessels, and the tumor had completely approached, surrounded or invaded the lumen of large vessels (such as pulmonary artery or superior vena cava);\n11. Subjects with hypertension (systolic blood pressure\\>160mmHg or diastolic blood pressure\\>100mmHg) that are still poorly controlled after treatment with two or more antihypertensive drugs in the screening period, and who have a history of hypertensive crisis or hypertensive brain disease in the past;\n12. Those with unhealed wounds, active digestive ulcer, fractures (excluding old healed fractures);\n13. Known or suspected to be allergic to aumolertinib and Anlotinib and\u002For other components of their preparations;\n14. Pregnant or lactating women;\n15. Women or male subjects of childbearing age who are unwilling to take effective contraceptive measures during the study period or within 6 months after the last administration of the study drug\n16. In addition to the above conditions, the researcher believes that there are other conditions that are not suitable for selection",{"count":179,"type":21},47,[24],"The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.",[183,29,184,27,185],"Aumolertinib","TP53","EGFR Activating Mutation","2023-03-08",{"date":188,"type":35},"2023-03-21",{"date":190,"type":21},"2023-03-31",{"date":192,"type":21},"2027-03-31",{"name":194,"class":42},"Tianjin Medical University Cancer Institute and Hospital"]