[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sbrt\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sbrt":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,69,98,123,147,169,194],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100641015","phase-2-adc-and-sbrt-for-recurrentmetastatic-salivary-gland-carcinoma-100641015",false,"NCT07579598","ADC and SBRT for Recurrent\u002FMetastatic Salivary Gland Carcinoma","Antibody-Drug Conjugate Plus Stereotactic Body Radiotherapy in Recurrent or Metastatic Salivary Gland Carcinoma - A Phase II Exploratory Study","Inclusion Criteria:\n\n1. Provide written informed consent prior to the initiation of any study-specific procedures.\n2. Male or female patients aged 18-80 years.\n3. Histologically or cytologically confirmed head and neck squamous cell carcinoma or adenoid cystic carcinoma, expressing ADC-related targets (e.g., EGFR, TROP2), with evidence of recurrence and\u002For metastasis.\n4. Patients must have experienced disease progression after first-line standard therapy or be deemed unsuitable for such therapy, and meet the following conditions: (1) For adenoid cystic carcinoma, first-line treatment should include anti-angiogenic agents (e.g., TKIs or monoclonal antibodies), chemotherapy, or patients are considered unsuitable for standard first-line therapy by the investigator (e.g., high bleeding risk, non-healing wounds); (2) For other salivary gland carcinomas, patients must have progressed after first-line standard therapy or be unsuitable for such therapy.\n5. At least one measurable lesion according to RECIST version 1.1 based on imaging.\n6. Life expectancy of at least 6 months.\n7. ECOG performance status (PS) score of 0-1.\n8. Adequate organ function, defined by the following laboratory criteria: (1) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL without use of granulocyte colony-stimulating factor within 14 days prior to testing; (2) Platelet count ≥ 90 × 10⁹\u002FL without transfusion within 14 days prior to testing; (3) Hemoglobin \\> 9 g\u002FdL without transfusion or erythropoietin use within 14 days prior to testing; (4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); (5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; (6) Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); (7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Patients with abnormal baseline TSH may still be eligible if total T3 (or FT3) and FT4 are within normal limits; (9) Myocardial enzyme levels within the normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are acceptable); (10) Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (Cycle 1 Day 1). If a urine test result is inconclusive, a serum test is required. Women of non-childbearing potential are defined as those who are postmenopausal for at least 1 year, or who have undergone surgical sterilization or hysterectomy; (11) Willingness and ability to comply with study procedures, including treatment, contraceptive measures, scheduled visits, and follow-up assessments.\n\nExclusion Criteria:\n\n1. Diagnosis of malignancies other than head and neck tumors within 5 years prior to the first dose (except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ following curative resection).\n2. Participation in another interventional clinical study or receipt of investigational drugs\u002Fdevices within 4 weeks prior to the first dose.\n3. Prior treatment with ADC agents.\n4. Treatment of traditional Chinese medicines with antitumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; except for local use for pleural effusion control) within 2 weeks prior to the first dose.\n5. Known hypersensitivity to the active ingredients or excipients of the study drug.\n6. Failure to recover from toxicities and\u002For complications caused by prior interventions to ≤ Grade 1 or baseline (excluding fatigue or alopecia) prior to treatment initiation.\n7. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV-1\u002F2 antibody positive).\n8. Untreated active hepatitis B infection (defined as HBsAg positive with HBV-DNA levels above the upper limit of normal for the study center laboratory). Note: Patients with hepatitis B may still be eligible if: (1) HBV viral load \\\u003C 2.5 × 10³ copies\u002FmL (500 IU\u002FmL) prior to first dosing, and patients receive anti-HBV therapy throughout the study; (2) Patients with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load do not require prophylactic anti-HBV therapy but must be closely monitored for viral reactivation.\n9. Active hepatitis C infection (HCV antibody positive with HCV-RNA above the lower limit of detection).\n10. Pregnant or breastfeeding women.\n11. Presence of any severe or uncontrolled systemic disease, including but not limited to: (1) Significant and symptomatic abnormalities in cardiac rhythm, conduction, or morphology on resting ECG that are difficult to control, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation; (2) Unstable angina, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) class ≥ II; (3) Any arterial thrombosis, embolism, or ischemic event within 6 months prior to enrollment (e.g., myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack); (4) Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to the first dose, or presence of unhealed wounds, ulcers, or fractures. Tissue biopsy or minor surgical procedures within 7 days prior to first dosing are also exclusionary, except for venous catheter placement for infusion; (5) Poorly controlled hypertension (systolic \\>140 mmHg and\u002For diastolic \\>90 mmHg); (6) Active pulmonary tuberculosis; (7) Active or uncontrolled infections requiring systemic therapy; (8) Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; (9) Liver diseases such as cirrhosis, decompensated liver disease, or acute\u002Fchronic active hepatitis; (10) Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL); (11) Proteinuria ≥ ++ on urinalysis confirmed by 24-hour urinary protein \\>1.0 g; (12) Psychiatric disorders that interfere with treatment compliance; (13) Any medical history, disease condition, treatment, or laboratory abnormality that may interfere with study results or the patient's full participation, or any other condition deemed unsuitable for enrollment by the investigator.","ALL","18 Years","80 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-arm, single-center, exploratory clinical study. The study plans to enroll patients with recurrent or metastatic head and neck salivary gland carcinoma (HN-SGC) . The trial comprises two cohorts: Cohort 1 (adenoid cystic carcinoma, ACC) and Cohort 2 (non-ACC SGC). Patients in Cohort 1 will initially receive MRG003, an EGFR-targeted antibody-drug conjugate (ADC). Patients in Cohort 2 will initially receive either MRG003 (EGFR-ADC) or a TROP2-targeted ADC. The selection between these two ADC therapies for Cohort 2 will be determined by the investigator based on the expression levels of specific tumor surface receptors.\n\nTumor response will be assessed by imaging every 6 weeks (±7 days). Subjects who are assessed as having stable disease (SD) on two consecutive evaluations or who develop oligometastatic progression will receive stereotactic body radiation therapy (SBRT). Following SBRT, maintenance therapy with the original ADC will be continued.\n\nTreatment discontinuation will be permitted due to disease progression, death, intolerable toxicity, withdrawal of consent, initiation of new anti-tumor therapy, or other protocol-specified reasons, whichever occurs first. After treatment completion, all subjects will enter a post-treatment phase for safety visits and survival follow-up. For subjects who discontinue treatment for reasons other than disease progression or death, tumor progression follow-up will also be conducted during the post-treatment period.",[27,28,29],"Adenoid Cystic Carcinoma of the Head and Neck","SBRT","Antibody-drug Conjugates","NOT_YET_RECRUITING","2026-05-05",{"date":33,"type":34},"2026-05-12","ACTUAL",{"date":36,"type":21},"2026-05-01",{"date":38,"type":21},"2027-12-12",{"name":40,"class":41},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"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":50,"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.",[54,55,56,57,58,28],"Hepatocellular Carcinoma (HCC)","First-line Targeted Therapy Failure","Oligometastatic Hepatocellular Carcinoma","Benmelstobart","Anlotinib","2026-04-13",{"date":61,"type":34},"2026-04-17",{"date":63,"type":21},"2026-04-20",{"date":65,"type":21},"2028-08-31",{"name":67,"class":41},"Nanfang Hospital, Southern Medical University",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100626923","single-fraction-pulmonary-ablative-radiotherapy-outcomes-and-quality-of-life-workup-100626923","NCT07441941","Single-Fraction Pulmonary Ablative Radiotherapy Outcomes and Quality-of-life Workup","Quality-of-Life Assessment Following Single-Fraction Stereotactic Radiotherapy (SF-SBRT) for Inoperable Primary and Oligometastatic Lung Tumor","SPARROW","Inclusion Criteria:\n\n* Age: ≥ 18 years\n* Patient receiving single-fraction stereotactic body radiation therapy (SBRT)\n* Stage T1-2 N0 M0 non-small cell lung cancer (NSCLC) (AJCC 6th edition) or oligometastatic lung tumor defined by ≤ 3 lung metastasis.\n* Inoperability: Tumor is inoperable or patient refuses surgery\n* Tumor size: ≤ 3 cm\n* Peripheral tumors: \\> 2 cm from proximal bronchial tree but ≥ 0.5 cm from the wall\n* Histologically proven or with evolution criteria (CT scan and PET scan)\n* ECOG performance status: 0-2\n* Ability to comply: Willingness and ability to comply with scheduled visits and other study procedures\n* Informed consent: Written informed consent obtained\n* Insurance: Patient is affiliated with a French health insurance plan\n\nExclusion Criteria:\n\n* Tumors invading the pleura or mediastinum.\n* Concurrent infectious pneumonia or pericarditis.\n* Prior radiotherapy to the treatment field.\n* Presence of neoadjuvant treatment for the present cancer.\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results\n* Patients under guardianship, curatorship or safeguard of justice,\n* Pregnant or breast-feeding subjects\n* Concomitant participation or participation within the last 30 days in another clinical trial\n* Patient with an estimated life expectancy of less than 6 months.",{"count":78,"type":21},190,"OBSERVATIONAL","Pulmonary tumors, whether primary or metastatic, represent a major challenge in oncology.\n\nPrimary lung cancers are responsible for nearly 37,000 deaths per year in France, highlighting the critical importance of their management. Moreover, secondary pulmonary lesions are present in 20% of solid cancers and show wide variability in prognosis. Oligometastatic disease (≤ 3 to 5 lesions) is associated with a better prognosis, justifying the development of local treatments for these lesions, particularly stereotactic radiotherapy.\n\nDuring the COVID-19 pandemic, single-fraction protocols (30-34 Gy) were implemented to limit patient exposure, showing outcomes equivalent to multi-fraction regimens for both primary and secondary lesions.\n\nHowever, the impact of these treatments on quality of life remains poorly documented-especially for non-small cell lung carcinoma-and needs to be further explored to optimize their integration into routine clinical practice.\n\nThe primary objective of this study is to assess the impact of single-fraction stereotactic body radiotherapy (SBRT) for pulmonary lesions on quality of life.\n\nTo this end, patients will complete a standardized French-language quality of life questionnaire, the EORTC QLQ-C30 and LC-29, before treatment and at 1 month (M1), 3 months (M3), 6 months (M6), 9 months (M9), and 12 months (M12) after treatment.\n\nThis validated, disease-specific questionnaire comprises 59 items: 30 assessing overall quality of life (QLQ-C30) and 29 addressing aspects related to lung cancer treatments (LC-29). It includes questions on respiratory symptoms, chest pain, fatigue, and the functional impact of the treatment.",[82,83,28],"Oligometastatic Lung Tumor","NSCLC (Non-small Cell Lung Cancer)",[85,28,86],"Quality of life","Lung tumor","RECRUITING","2026-02-26",{"date":90,"type":34},"2026-03-02",{"date":92,"type":34},"2026-01-14",{"date":94,"type":21},"2028-11-30",{"name":96,"class":41},"Institut du Cancer de Montpellier - Val d'Aurelle",2,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":97},"100568092","phase-2-sbrt-combined-with-nimotuzumab-and-tislelizumab-for-oligoprogressive-recurrentmetastatic-nasopharyngeal-carcinoma-after-failure-of-immunotherapy-100568092","NCT06676722","SBRT Combined With Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent\u002FMetastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy","A Prospective, Single-Arm, Exploratory Study of SBRT Combined With Nimotuzumab and Sequential Tislelizumab for Oligoprogressive Distant Recurrent\u002FMetastatic Nasopharyngeal Carcinoma After Failure of First-Line Immunotherapy","1. Inclusion Criteria:\n\n   1.1. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; 1.2. Patients with recurrent\u002Fmetastatic nasopharyngeal carcinoma who have previously received first-line treatment including anti-PD-1 immune checkpoint inhibitor therapy and failed, presenting with oligoprogression (1-5 metastatic lesions); 1.3. Eligible to receive SBRT, Tislelizumab, and Nimotuzumab; 1.4. No history of other malignant tumors; 1.5. Male or female, aged 18-75 years; 1.6. Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 × ULN; Alkaline phosphatase ≤ 5 × ULN; 1.7. Renal function: Creatinine clearance ≥ 80 mL\u002Fmin; 1.8. Hematological tests: Absolute neutrophil count (ANC) ≥ 2 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, and hemoglobin ≥ 9 g\u002FdL; 1.9. No severe dysfunction of heart, lung, and other vital organs; 1.10. Performance Status (PS) score ≤ 2.\n2. Exclusion Criteria:\n\n2.1. Disagree to sign the informed consent form; 2.2. Patients who cannot comply with regular follow-ups due to psychological, social, family, or geographical reasons; 2.3. Receiving other experimental treatments as part of a clinical study (during the treatment period of the clinical study); 2.4. Severe, uncontrolled infections or medical conditions; 2.5. Major organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy or immunotherapy; 2.6. Factors affecting drug administration, distribution, metabolism, or excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.; 2.7. Overexposure to glucocorticoids within 2 weeks before immunotherapy; 2.8. Long-term use of immunosuppressive agents after organ transplantation.",true,"75 Years",{"count":108,"type":21},20,[24],"This study is a single-arm, open-label, prospective, and exploratory investigation aimed at examining the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent\u002Fmetastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.",[112,28,113],"Nasopharyngeal Cancinoma (NPC)","Immunotherapy","2025-06-30",{"date":116,"type":34},"2025-07-01",{"date":118,"type":34},"2024-11-05",{"date":120,"type":21},"2027-12-31",{"name":122,"class":41},"The First Affiliated Hospital of Xiamen University",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":130,"minAge":4,"maxAge":4,"enrollmentInfo":131,"targetDuration":133,"studyType":79,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":68},"100465708","observational-study-on-extreme-hypofractionation-for-localized-prostate-cancer-100465708","NCT05344235","Observational Study on Extreme Hypofractionation for Localized Prostate Cancer","OBELIX PCa","Inclusion Criteria:\n\n* men ≥ 18 years\n* histologically confirmed clinically localized adenocarcinoma of the prostate\n* intermediate- or high-risk PCa, defined as\n\nOR at least one of the following criteria:\n\n* clinical stage: cT2a-c, cT3a or cT3b (AJCC 7th edition)\n* Gleason Score ≥ 7 (ISUP grade group 2 or higher)\n\nOR at least two of the following criteria:\n\n* clinical stage: cT1c (AJCC 7th edition)\n* Gleason Score ≥ 7 (ISUP grade group 2 or higher)\n* calculated risk for lymph node involvement (Roach formula) \\\u003C35%.\n* no evidence of disease spread beyond the prostate and\u002For seminal vesicles\n* imaging with mpMRI of the prostate and pelvis (compliant with the PIRADS v2.1 guidelines) within 90 days prior to registration, or required to be performed after registration to the trial\n* ability to understand, and willingness to sign, the written informed consent\n* willingness to comply with scheduled visits, treatment, and other procedures\n\nExclusion Criteria:\n\n* prior pelvic irradiation (external beam radiotherapy or brachytherapy)\n* previous radical prostatectomy, cryosurgery, or HIFU for prostate cancer\n* previous or concurrent cytotoxic chemotherapy for prostate cancer\n* patients with neuroendocrine or small cell carcinoma of the prostate\n* clinical stage cT4 (invasion of adjacent organ like bladder or rectum, visualized on mpMRI and\u002For ultrasound and endoscopy) (AJCC 7th edition)\n* significant urinary obstruction of other voiding symptoms (IPSS \\> 18) is allowed, however should be discussed with the principal investigator and left to the discretion of the treating physician\n* high risk of lymph node involvement, as calculated with the Roach formula ≥ 35% (https:\u002F\u002Fwww.evidencio.com\u002Fmodels\u002Fshow\u002F1144) Of note, in case of ambiguity of regional lymph node involvement on CT or MRI findings (when Roach formula is \\\u003C 35%, and all other eligibility criteria are met), dedicated imaging with PSMA PET-CT or extended pelvic lymph node dissection must be obtained to rule out lymph node involvement\n* evidence of distant metastases (based on CT scan, MRI of the pelvis, bone scan within 90 days prior to registration; if the bone scan is suspicious but not unequivocal, dedicated X-ray and\u002For MRI must be obtained to rule out metastasis)\n* contraindications to MRI according to the Radiology Department guidelines (metal implants, noncompatible cardiac device, deep brain stimulators, cochlear implants, metallic foreign body in the eye or aneurysm clips in the brain, severe claustrophobia).\n* World Health Organization (WHO) performance score \\> 2\n* patients with severe inflammatory bowel disease rendering radiotherapy impossible (active Crohn's Disease or Ulcerative Colitis), or patients known with ataxia telangiectasia\n* implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion\n* prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous\u002Fhematogenous malignancy unless continually disease-free for a minimum of 5 years.\n\n(carcinoma in situ of the bladder or oral cavity is permissible)","MALE",{"count":132,"type":21},246,"5 Years","Radiotherapy (RT) is an established treatment option for localized prostate cancer (PCa), with cure rates similar to those of radical prostatectomy. In the last decade, conventionally fractionated RT (1.8-2.0 Gy per fraction to 78-80 Gy) has been replaced by moderately hypofractionated RT (2.3-3.65 Gy per fraction to 56-70 Gy). The rationale behind this change is the scientific level 1 evidence that a higher dose per fraction may improve the cost-benefit of RT due to the specific radiobiology of PCa (a lower alpha\u002Fbeta than that of adjacent healthy tissues). Additionally, there is a practical advantage both for patients and the radiation department due to a reduced number of fractions.\n\nMore recently, extreme hypofractionation or stereotactic body radiotherapy (SBRT) (7-9.5 Gy per fraction to 36-43 Gy in 4-7 fractions) has been introduced as RT modality, and proved to be an effective and safe treatment option for patients with low and intermediate clinically-localized PCa, with similar incidence of late toxicity and 5-year disease free survival outcomes when compared to hypofractionated and conventional radiotherapy regimens. International guidelines endorse extreme hypofractionated SBRT as routine treatment option for low and intermediate risk PCa patients. For high-risk prostate cancer, preliminary results of ongoing prospective studies are promising, but these data are not yet mature enough to recommend extreme hypofractionated SBRT in high-risk prostate cancer. Upon this, ongoing prospective trials handle strict eligibility criteria hereby selecting patients with few comorbidities. This may not necessarily fully reflect the real life patient population. Indeed, patients with a large prostate size, a history of transurethral resection of the prostate (TURP), or 'significant' urinary baseline symptoms may be at risk for experiencing increased toxicity. Based on this concern, these patients were excluded from ongoing clinical trials. However, whether these patients will really develop more toxicity, is a theoretical concern, not yet based on clinical evidence. It is our hypothesis that using modern radiotherapy such as volumetric arc therapy (VMAT) and image-guided radiotherapy (IGRT) - both standard technologies at the Radiation-Oncology department in Leuven University Hospitals - extreme hypofractionated SBRT can be successfully implemented in the treatment of intermediate risk and a select group of high-risk PCa patients and\u002For patients with pre-existing urinary morbidity.",[136,137,28],"Prostate Cancer","Radiotherapy","2025-03-25",{"date":140,"type":34},"2025-03-30",{"date":142,"type":34},"2022-04-25",{"date":144,"type":21},"2032-04",{"name":146,"class":41},"Universitaire Ziekenhuizen KU Leuven",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":68},"100571610","efficacy-and-safety-of-a-third-course-of-neoadjuvant-immunochemotherapy-combined-with-sbrt-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-patients-with-stable-disease-after-two-treatment-courses-a-single-arm-exploratory-study-100571610","NCT06722495","Efficacy and Safety of a Third-Course of Neoadjuvant Immunochemotherapy Combined With SBRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Patients With Stable Disease After Two Treatment Courses: A Single-Arm Exploratory Study","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years on the date of signing the informed consent form, male or female.\n2. Histologically and imaging-confirmed T3-4a or N+M0 stage III-IVb (AJCC 8th) HNSCC, patients have received 2-courses of platinum-based chemotherapy and tirilizumab immunotherapy, and whose efficacy is assessed as Stable Disease (SD).\n3. Life expectancy is at least 3 months.\n4. ECOG PS 0-1。\n5. Haematological analysis： 5.1 Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL without granulocyte colony-stimulating factor in the last 14 days； 5.2 Absolute T-lymphocyte value ≥ 0.5 times the lower limit of normal value； 5.3 Platelets ≥100×10\\^9\u002FL without transfusion or platelet-boosting drugs in the last 14 days； 5.4 Haemoglobin ≥90g\u002FL without transfusion or erythropoietin use in the last 14 days.\n6. Renal function:\n\n   6.1 Creatinine clearance\\* (Ccr) ≥60 mL\u002Fmin; \\*Ccr will be calculated using the Cockcroft-Gault formula: Ccr = (140-age) × body weight (kg) \u002F \\[0.818 (0.85 for males, 0.85 for females) × blood creatinine (SCr, umol\u002FL) \\] or Ccr = (140-age) × body weight (kg)\u002F \\[72 × blood creatinine (SCr, mg\u002FdL) \\]; 6.2 Creatinine ≤ 1.5 × upper limit of normal (ULN)； 6.3 Routine urinalysis suggests urinary protein ≤ +; 6.4 Quantitative 24-hour urine protein \\\u003C1.0g.\n7. Liver function:\n\n   7.1 Serum total bilirubin (TBil) ≤ 1.5 × ULN; 7.2 AST and ALT ≤ 2.5 × ULN, ≤ 5 × ULN for liver metastases, and TBil ≤ 3 × ULN.\n8. Coagulation: international normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n9. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may be enrolled if total T3 (or FT3) and FT4 are within the normal range.\n10. Cardiac enzyme profiles within the normal range (enrolment is also permitted if the investigator's combined judgement is that it is a purely laboratory abnormality of no clinical significance).\n11. Patients must be able to understand and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any of the antineoplastic therapeutic drug components of this research.\n2. Those who have previously suffered from other malignant tumours and have received radiotherapy.\n3. have uncontrolled clinical symptoms or cardiac disease including, but not limited to, symptomatic congestive heart failure (Grade 2 and above as determined by the New York Heart Association's Functional Class), unstable angina pectoris, acute myocardial ischaemia, and poorly controlled cardiac arrhythmias. Past history of myocarditis and cardiomyopathy.\n4. Active autoimmune disease requiring systemic therapy (e.g., use of disease-mitigating drugs, glucocorticoids, or immunosuppressants). Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy.\n5. History of (non-infectious) pneumonia requiring steroids or current pneumonia.\n6. Have active tuberculosis.\n7. History of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first dose or current clinically active interstitial lung disease.\n8. Active or uncontrolled infection requiring systemic therapy.\n9. History of human immunodeficiency virus (HIV) infection (e.g., HIV-positive).\n10. Liver disease such as cirrhosis, decompensated liver disease; known active hepatitis B (e.g., hepatitis B surface antigen (HBsAg) positive and HBV-DNA \\> upper limit of normal in the laboratory of the research centre) or active hepatitis C virus infection (e.g., HCV antibody positive and HCV RNA level above the lower limit of detection).\n\n    \\*Note: Hepatitis B subjects meeting the following criteria may also be enrolled: 10.1 HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the study treatment period to avoid viral reactivation; 10.2 In subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is needed.\n11. Have an active bleeding disorder or other history of severe bleeding.\n12. Allogeneic organ transplantation (except corneal transplantation) or allogeneic haematopoietic stem cell transplantation.\n13. Pregnant or breastfeeding, or preparing to become pregnant during the trial period.\n14. Medical, psychological, or social condition that may interfere with the subject's participation in the research or affect the assessment of the results; or other conditions that, in the opinion of the investigator, make enrolment inappropriate, or that, in the opinion of the investigator, present other potential risks that make participation in this research inappropriate.",{"count":108,"type":21},[155],"NA","Neoadjuvant immunotherapy before surgery has shown good efficacy and safety in locally advanced HNSCC, particularly with the use of PD-1 inhibitors combined with chemotherapy, where some patients have achieved a high rate of pathological complete response. However, approximately 40% of patients respond poorly to neoadjuvant immunochemotherapy, with prolonged treatment courses failing to significantly improve outcomes, and some patients may even experience disease progression. For these patients, timely surgery or definitive radiotherapy combined with other well-tolerated therapeutic approaches is needed to improve pathological response rates, enhance long-term survival, and preserve organ function.",[28,158,159],"Neoadjuvant Immunochemotherapy","LA HNSCC","2024-12-05",{"date":162,"type":34},"2024-12-09",{"date":164,"type":21},"2024-12-24",{"date":166,"type":21},"2026-12-26",{"name":168,"class":41},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100557501","phase-2-sbrt-combined-with-adbelimumab-and-apatinib-for-perioperative-and-conversion-therapy-of-hepatocellular-carcinoma-100557501","NCT06538935","SBRT Combined With Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma","A Phase II, Open-label, Two Arm, Investigator-initiated Trail of Stereotactic Radiotherapy (SBRT) in Combination With an Anti-PD-L1 Inhibitor Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. The patient volunteered to participate in the study and signed an informed consent form\n2. ≥18 years of age，Male or female\n3. Subjects are diagnosed with histologically or cytologically confirmed HCC\n4. Subjects haven't received any systemic treatment for HCC before admission.\n5. Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard\n6. ECOG performance status of 0 or 1\n7. Life expectancy ≥ 12 weeks\n8. Subjects are diagnosed with resectable stage IB- IIIA HCC cancer.\n9. The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)\n\n   * Absolute neutrophil count≥1.5×109 \u002FL\n   * Platelets≥75×109\u002FL ;Hemoglobin≥9.0 g\u002FdL; Serum albumin≥3g\u002FdL\n   * Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)（If abnormal, T3 and T4 levels should be examined at the same time）\n   * Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)\n   * Serum creatinine ≤1.5×ULN or creatinine clearance \\> 60 mL\u002Fminute (using Cockcroft-Gault formula)\n\nExclusion Criteria:\n\n1. Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously\n2. Be ready for or previously received organ or allogenic bone marrow transplantation\n3. Moderate-to-severe ascites with clinical symptoms\n4. History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage.\n5. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment.\n6. Known genetic or acquired hemorrhage or thrombotic tendency.\n7. Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.\n8. Cardiac clinical symptom or disease that is not well controlled.\n9. Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment ；Subjects have had a hypertensive crisis or hypertensive encephalopathy\n10. Patient develops severe vascular disease within 6 months before the start of study treatment.\n11. Patients with severe, unhealed or split wounds and active ulcers or untreated fractures.\n12. Patients who underwent surgical treatment within 4 weeks prior to the start of study treatment.\n13. Factors to affect oral administration (such as patients unable to swallow oral medications, malabsorption syndrome etc. situations evidently affect drug absorption).\n14. Patients with gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or those who may have caused gastrointestinal bleeding, perforation or obstruction.\n15. There is evidence of intragastric gas that cannot be explained by puncture or recent surgery.\n16. Previous or current presence of metastasis to central nervous system.\n17. Subjects have history of hepatic encephalopathy.\n18. The subject has an interstitial lung disease that is symptomatic or may interfere with the discovery or management of suspected drug-related lung toxicity; previous and current subjects with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-associated pneumonia, severe impaired lung function, etc.\n19. The patient has any active autoimmune disease or a history of autoimmune disease expected relapse.\n20. Severe infection within 4 weeks prior to the start of study treatment.\n21. A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease.\n22. The patient is pregnant or breastfeeding.\n23. Subjects were vaccinated with live attenuated vaccine within 28 days before the first dose or expected to receive this vaccine within 60 days after the last dose or during the study period.\n24. Treatment of other investigational product(s) within 28 days prior to the start of study treatment.\n25. Other factors deemed unsuitable for participation in this study by the researchers.",{"count":177,"type":21},80,[24],"This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.",[181,28,182,183],"Hepatocellular Carcinoma","Immune Checkpoint Blockade","Tyrosine Kinase Inhibitor","2024-08-05",{"date":186,"type":34},"2024-08-06",{"date":188,"type":21},"2025-01",{"date":190,"type":21},"2027-12",{"name":192,"class":193},"Fujian Cancer Hospital","OTHER_GOV",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":68},"100532989","phase-2-sbrt-followed-by-neoadjuvant-chemoimmunotherapy-of-sindilizumab-plus-docetaxel-and-cisplatin-for-locoregionally-advanced-squamous-carcinoma-of-oral-cavity-and-oropharynx-100532989","NCT06219980","SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx","A Phase II Study of SBRT Followed by Neoadjuvant Chemoimmunotherapy of Sindilizumab Plus Docetaxel and Cisplatin for Locoregionally Advanced Squamous Carcinoma of Oral Cavity and Oropharynx","Inclusion Criteria:\n\n* pathologically confirmed squamous carcinoma of oral cavity or oropharynx\n* III-IVa based on the eighth edition of AJCC\n* aged 18 to 70\n* ECOG PS 0-1\n* no organ dysfunction\n* Expected survival ≥ 3 months\n\nExclusion Criteria:\n\n* diagnosed with other malignant tumors\n* has autoimmune diseases or serious mental illness\n* at high risk of hemorrhage\n* Systemic or local glucocorticoid therapy within 4 weeks\n* Comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids in immunosuppressive doses\n* Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.\n* Prior use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody\n* HIV or HCV\n* HBsAg positive with positive HBV DNA copy number (quantitative test) ≥1000cps\u002Fml","70 Years",{"count":203,"type":21},25,[24],"In resectable locally advanced oral cavity cancer and oropharyngeal cancer, SBRT with the total dose of 18 Gy by three fractions will be delivered to the primary tumor and metastatic lymph nodes every other day. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg\u002Fm2) and cisplatin (75mg\u002Fm2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics. The investigators aim to evaluate the pathological complete response rate and safety of the combined treatment of SBRT with chemoimmunotherapy in locally advanced cancers of oral cavity and oropharynx.",[28],[28,208,209,210],"immunotherapy","oral cancer","oropharyngeal cancer","2024-03-08",{"date":213,"type":34},"2024-03-12",{"date":215,"type":34},"2023-12-07",{"date":217,"type":21},"2026-12-07",{"name":219,"class":41},"Sun Yat-sen University"]