[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nasopharyngeal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nasopharyngeal-cancer":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,100,132,161,193,221,246,273,295,324,351,376,399,421,451,483,509,540,566],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":77,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100210159","integrated-cancer-repository-for-cancer-research-100210159",false,"NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"ALL","19 Years","110 Years",{"count":21,"type":22},999999,"ESTIMATED","80 Years","OBSERVATIONAL","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Prostate Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Multiple Myeloma","Ovarian Cancer","Endometrial Cancer","Vaginal Cancer","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[27,28,78,79,80,81,82,83,84,85,65,86,75,76],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","RECRUITING","2026-06-25",{"date":90,"type":91},"2026-06-29","ACTUAL",{"date":93,"type":91},"2013-11-01",{"date":95,"type":22},"2099-12",{"name":97,"class":98},"University of Nebraska","OTHER",42,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100568531","induction-chemotherapy-response-guided-radiation-for-ebv-associated-nasopharyngeal-carcinoma-100568531","NCT06682442","Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed (from primary lesion and\u002For lymph nodes) nasopharyngeal carcinoma.\n* Participants must have Epstein Barr virus (EBV)-associated nasopharyngeal carcinoma, defined as detectable (\\> 0 copies\u002FmL) circulating plasma EBV DNA on a qualitative or quantitative polymerase chain reaction (PCR)-based test.\n* Stage III-IVA disease (American Joint Committee on Cancer \\[AJCC\\], 8th edition \\[ed.\\]) with no evidence of distant metastasis at the time of diagnosis based upon all 3 of the following minimum diagnostic workup criteria:\n\n  * History\u002Fphysical examination by a medical oncologist or clinical oncologist or radiation oncologist or otolaryngology (ENT);\n  * Evaluation of tumor extent with either one of the following:\n\n    * MRI with contrast of the face, nasopharynx, and neck or CT with contrast of the face, nasopharynx and neck with ≤ 3 mm contiguous slices and bone windows to evaluate base of skull involvement; or\n    * MRI of the nasopharynx and PET\u002FCT (with contrast) of the neck\n  * Imaging to rule out distant metastasis:\n\n    * CT scan with contrast of the chest and abdomen (required) and the pelvis (optional) or a total body PET\u002FCT scan (non-contrast PET\u002FCT is acceptable); and\n    * Only if clinically indicated: Bone scan only when there is suspicion of bone metastases (a PET\u002FCT scan can substitute for the bone scan)\n* Started or planning to start platinum-based induction systemic therapy.\n* Planning to receive intensity modulated radiation therapy (IMRT) with concurrent, platinum-based systemic therapy during radiation.\n* Use of adjuvant (post-chemoradiation) immunotherapy is permitted.\n* Age \\>=18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%).\n* Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy are eligible for this trial.\n* For individuals with evidence of chronic hepatitis B virus (HBV) infection: must be on suppressive therapy, if indicated.\n* For individuals with a history of hepatitis C virus (HCV) infection: must be currently on treatment, or must have been treated and cured.\n* Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 60 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior systemic chemotherapy for nasopharyngeal carcinoma, other than induction chemotherapy (IT); note that prior chemotherapy for a different cancer is permitted\n* Prior radiotherapy to the nasopharynx or surrounding involved areas that would result in overlap of radiation therapy fields\n* Has participated in a study of an investigational product and received treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose of treatment\n* Severe, active comorbidity, defined as any of the following:\n\n  * Major medical or psychiatric illness that, in the treating investigator's opinion, would interfere with the completion of therapy and follow-up or interfere with a full understanding of the risks and potential complications of the therapy\n  * Unstable angina, congestive heart failure, or peripheral vascular disease requiring hospitalization within the last 12 months; or other cardiac compromise that in the judgment of the treating investigator will preclude safe administration of study treatment\n  * Chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization within 30 days prior to registration, or which would preclude safe administration study therapy in the opinion of the treating investigator\n  * Active, untreated infection and\u002For acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n* Because the radiation therapy used in this trial is known to be teratogenic, individuals of child-bearing potential must have documentation in their medical record of a negative pregnancy test\n\n  \\* A female participant is considered to NOT be of child-bearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participant meets either of the following two criteria:\n  * Has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause)\n  * Has undergone surgical sterilization (i.e., hysterectomy and\u002For bilateral oophorectomy for removal of uterus and\u002For ovaries)\n* Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study activities or interfere with participant safety or study endpoints","18 Years",{"count":108,"type":22},66,"INTERVENTIONAL",[111],"NA","This clinical trial tests the effect of induction chemotherapy response-guided radiation (de-escalated intensity-modulated radiation therapy \\[IMRT\\]) compared to standard IMRT in patients with Epstein-Barr virus (EBV)-associated nasopharyngeal cancer. Intensity-modulated radiation therapy (IMRT) is an advanced form of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Radiation therapy sometimes causes unwanted symptoms or side effects, including late effects such as hearing loss and dental problems. The severity of the side effects is related to the radiation dose received and the amount of tissue that received radiation. De-escalation IMRT uses lower doses of radiation based on a good response to induction chemotherapy. Giving de-escalated IMRT may be as effective as standard doses of IMRT in treating patients with EBV-associated nasopharyngeal cancer.",[114,115,116,56,117],"Nasopharyngeal Carcinoma","Stage III Nasopharyngeal Carcinoma AJCC v8","Stage IVA Nasopharyngeal Carcinoma AJCC v8","Nasopharyngeal Cancer Stage",[119,120,121],"HHV-4 Positive","EBV Positive","human herpesvirus 4 (HHV-4) positive","2026-06-15",{"date":124,"type":91},"2026-06-17",{"date":126,"type":91},"2025-03-18",{"date":128,"type":22},"2032-03-31",{"name":130,"class":98},"University of California, San Francisco",1,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":109,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100642704","phase-1-a-study-of-cemiplimab-and-fianlimab-in-people-with-nasopharyngeal-carcinoma-100642704","NCT07650266","A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma","A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18\n* Pathologically (histologically or cytologically) proven (from primary lesion and\u002For lymph node) diagnosis of non-keratinizing nasopharynx carcinoma\n* Pathologic confirmation of EBV status in biopsy sample. EBER (Epstein-Barr virus-encoded RNA) detection via immunohistochemistry or in situ hybridization or polymerase chain reaction, collected as routine clinical standard to determine EBV status.\n* Patient must be seen by head and neck surgery, radiation oncology, medical oncology, as standard of care which includes standard nasopharyngoscopy. All three disciplines need to agree that the patient is eligible. Note: Nasopharyngoscopy does not need to be repeated by all three disciplines. This test is often only performed by head and neck surgery and\u002For radiation oncology.\n* AJCC 8th edition: T1N1, T2N0-1, T1-T2N2 nasopharynx carcinoma\n* ECOG performance status 0-1\n* Adequate organ and bone marrow function documented by:\n\n  * Hemoglobin \\> 9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) \\>1.5 x 109 \u002FL\n  * Platelet count \\>100 x 109 \u002FL\n  * Adequate renal function: Serum creatinine \\\u003C1.5 mg\u002FdL or creatinine clearance ≥ 50 ml\u002Fmin determined by 24-hour urine collection or estimated by Cockcroft-Gault formula\n  * Adequate hepatic function: - T bili \\\u003C1.5x ULN, AST or ALT \\\u003C 1.5 ULN, Alkaline phosphatase \\\u003C1.5 x ULN). Note: for patients with Gilbert Syndrome, total Bilirubin \\\u003C3x ULN.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n* Signed informed consent form by the participant.\n\nExclusion Criteria:\n\n\\- Evidence of distant metastatic disease by radiographic imaging. Equivocal findings are subject to P.I. and Co-PI approval\n\n* Prior head and neck radiation (Exceptions can be made if the overlap regions are minimal and must be approved by PI\u002FCo-PI)\n* Grade ≥2 hearing loss\n* Grade ≥2 peripheral sensory neuropathy\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater\n\n  o Note: Exceptions can be made for patients with prior or concurrent invasive malignancy if determined by the PI\u002FCo-PI, then the patient can proceed with protocol activities\n* Prior systemic chemotherapy for the study cancer o Note: prior chemotherapy for a different cancer is allowable, must check with PI\u002FCo-PI\n* Severe, active co-morbidity defined as follows:\n\n  o Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics treatment within 2 weeks prior to the first dose of trial medication\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.\n* Participants with a history of myocarditis.\n* TnT or troponin I TnI \\> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\> 1 to 2x ULN within 24 hours, the patient may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.\n* History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n* Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n\n  o Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n  * Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n  * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n* Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* Patients using immunosuppressive doses (≥10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study.\n* Received a live vaccine within 30 days of planned start of study medication, during treatment and for 90 days after treatment.\n\n  o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.\n* Woman of child bearing potential (WOCBP)\\* must have a negative serum (beta-hCG) within 14 days prior to registration.\n\n  * \\*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n  * Pregnancy testing and contraception are not required for women who are post-menopausal or permanently sterile.\n  * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation\n  * Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence†\n  * Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n  * Periodic abstinence‡, withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n* WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment\n* All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose\n* Pregnant or breastfeeding women. o WOCBP who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include: i. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; ii. intrauterine device; intrauterine hormone-releasing system; iii. bilateral tubal occlusion\u002Fligation; iv. vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For v. sexual abstinence† ‡\n\n  * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.\n\n    * Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.",{"count":140,"type":22},60,[142],"PHASE1","The purpose of this study is to find out whether cemiplimab, with or without fianlimab, is an effective treatment for advanced nasopharyngeal carcinoma (NPC), when given with standard chemotherapy drugs gemcitabine and cisplatin before standard chemoradiation.",[114,56,145,146],"Nasopharynx Carcinoma","Nasopharynx Cancer",[114,56,145,146,148,149,150],"Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma","Memorial Sloan Kettering Cancer Center","26-172","NOT_YET_RECRUITING","2026-06-10",{"date":154,"type":91},"2026-06-16",{"date":156,"type":22},"2026-07",{"date":158,"type":22},"2030-07",{"name":149,"class":98},7,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":109,"phases":170,"briefSummary":173,"conditions":174,"keywords":181,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":131},"100581542","phase-2-trop2-targeted-immunopet-imaging-of-solid-tumors-100581542","NCT06851663","Trop2-targeted immunoPET Imaging of Solid Tumors","Inclusion Criteria:\n\n* Aged 18-75 year-old and of either sex\n* Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;\n* Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n* Pregnancy；\n* Severe hepatic and renal insufficiency;\n* Allergic to single-domain antibody radiopharmaceuticals.","75 Years",{"count":169,"type":22},400,[171,172],"PHASE2","PHASE3","This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography\u002Fcomputed tomography (immunoPET\u002FCT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.",[175,176,177,45,48,29,56,40,178,71,179,72,28,180],"Solid Tumor","Solid Carcinoma","Uroepithelial Carcinoma","Cholangiocarcinoma","Cervical Cancer","Head and Neck Cancer",[182,183,175],"Trophoblast cell surface antigen 2 (Trop2)","ImmunoPET","2026-05-27",{"date":186,"type":91},"2026-05-29",{"date":188,"type":91},"2024-12-23",{"date":190,"type":22},"2027-12",{"name":192,"class":98},"RenJi Hospital",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":109,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":4},"100633263","phase-3-becotatug-vedotin-mrg003-with-pd-1-blockade-and-chemoradiotherapy-in-high-risk-locoregionally-advanced-nasopharyngeal-carcinoma-100633263","NCT07524413","Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma","A Randomized, Controlled, Multicenter, Phase III Trial of Becotatug Vedotin in Combination With PD-1 Blockade Plus Chemoradiotherapy Versus PD-1 Blockade Plus Chemoradiotherapy in Patients With High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years at the time of diagnosis, regardless of sex\n\n  2\\. Histologically confirmed newly diagnosed nasopharyngeal carcinoma (NPC) of non-keratinizing carcinoma histology (WHO classification)\n\n  3\\. Locoregionally advanced NPC staged as T4N2 or T1-4N3 according to the American Joint Committee on Cancer\u002FUnion for International Cancer Control (AJCC\u002FUICC) 9th edition staging system. All patients must undergo the following evaluations prior to initiation of any treatment to confirm clinical staging: complete medical history and physical examination, complete blood count (CBC) and biochemistry panel, plasma Epstein-Barr virus (EBV) DNA titer and serology, nasopharyngoscopy, magnetic resonance imaging (MRI) of the head and neck, chest X-ray or computed tomography (CT) of the chest, abdominal ultrasound, and bone scintigraphy. 18F-fluorodeoxyglucose positron emission tomography\u002FCT (¹⁸F-FDG PET\u002FCT) may be used as a substitute for the latter three imaging modalities.\n\n  4\\. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)\n\n  5\\. Willing to provide archived tumor tissue (primary or metastatic lesion, obtained within 2 years prior to enrollment) or fresh biopsy specimen. Patients unable to provide tumor tissue may still be enrolled at the investigator's discretion, provided all other eligibility criteria are met.\n\n  6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to first dose\n\n  7\\. Adequate organ function, as defined by the following laboratory parameters, obtained within 4 weeks prior to screening, with no blood transfusions, hematopoietic growth factors, or thrombopoietic agents administered during this period: a) Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; white blood cell count \\> 4 × 10⁹\u002FL; hemoglobin \\> 90 g\u002FL; platelet count \\> 100 × 10⁹\u002FL; b) Hepatic and renal function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL\u002Fmin; urinary protein ≤ 2+ or ≤ 1000 mg\u002F24 hours; c) Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients receiving stable low-dose anticoagulation therapy, such as aspirin 100 mg\u002Fday, are permitted)\n\n  8\\. Normal findings on thyroid function tests, serum amylase and lipase, pituitary function tests, inflammatory and infectious markers, cardiac enzyme panel, and electrocardiogram (ECG): a) Patients aged \\> 50 years with a smoking history must have normal pulmonary function test results; b) Patients with ECG abnormalities or a prior cardiovascular history (not meeting exclusion criteria) must additionally undergo myocardial function testing and echocardiography, with normal results required for enrollment\n\n  9\\. Willing and able to provide written informed consent and to comply with all protocol-specified requirements, including scheduled visits, treatment administration, laboratory assessments, and other study procedures\n\n  10\\. Patients of reproductive potential must agree to use effective contraception from the time of informed consent through 6 months after the last dose of study treatment. Women of childbearing potential (WOCBP), defined as premenopausal women and women within 2 years of menopause, must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.\n\nExclusion Criteria:\n\n* 1\\. History of any other malignancy within the past 5 years, with the exception of curatively treated cervical carcinoma in situ, papillary thyroid carcinoma, or basal cell carcinoma of the skin\n\n  2\\. Prior receipt of any anti-tumor therapy for nasopharyngeal carcinoma, or any of the following: a) Any ADC drug with a monomethyl auristatin E (MMAE) payload within 3 months prior to first dose; b) Any investigational drug from another clinical trial within 28 days prior to first dose; c) Major surgery within 28 days prior to first dose without full recovery, or planned major surgery within the first 12 weeks after initiation of study treatment\n\n  3\\. Positive human immunodeficiency virus antibody (HIV-Ab); active tuberculosis; active hepatitis B virus infection (HBV-DNA \\> 1 × 10³ copies\u002FmL); or active hepatitis C virus infection (HCV antibody positive and HCV-RNA above the lower limit of detection)\n\n  4\\. History of primary immunodeficiency, or active autoimmune disease requiring immunosuppressive therapy or systemic corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment. The following conditions are exempt: type 1 diabetes mellitus; hypothyroidism (including autoimmune thyroid disease) stable on hormone replacement therapy; psoriasis, vitiligo, or alopecia not requiring systemic treatment; and use of topical or inhaled corticosteroids, or short-term (≤ 7 days) systemic corticosteroids for prophylaxis or treatment of non-autoimmune, non-recurrent allergic conditions\n\n  5\\. Uncontrolled cardiac disease, including any of the following: (1) heart failure of New York Heart Association (NYHA) Class ≥ 2; (2) unstable angina; (3) myocardial infarction within the past 1 year; (4) prolonged QT interval (QTc \\> 450 ms in males or QTc \\> 470 ms in females), complete left bundle branch block, third-degree atrioventricular block, or supraventricular or ventricular arrhythmia requiring treatment or intervention\n\n  6\\. Hypertension inadequately controlled with two antihypertensive agents (systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg)\n\n  7\\. Poorly controlled blood glucose, defined as: (a) fasting blood glucose \\> 10 mmol\u002FL on two occasions, or (b) glycated hemoglobin (HbA1c) \\> 8%; or concurrent diabetic gangrene\n\n  8\\. History of interstitial lung disease (ILD) or pulmonary inflammation requiring steroid treatment (including pulmonary fibrosis and radiation pneumonitis), current ILD or pulmonary inflammation, or imaging findings at screening that cannot exclude suspected ILD or pulmonary inflammation\n\n  9\\. Concurrent pulmonary disease causing clinically severe respiratory impairment, including but not limited to: (a) any underlying pulmonary condition (e.g., pulmonary embolism, severe asthma, or severe chronic obstructive pulmonary disease \\[COPD\\] within 3 months prior to screening); (b) restrictive lung disease; (c) history of or concurrent interstitial pneumonitis, radiation pneumonitis, severe COPD, severe pulmonary insufficiency, or symptomatic bronchospasm\n\n  10\\. Unstable thromboembolic events requiring therapeutic intervention within 6 months prior to screening, including deep vein thrombosis, arterial thrombosis, or pulmonary embolism; catheter-related thrombosis is exempt\n\n  11\\. Pregnant or breastfeeding women (pregnancy testing should be considered for sexually active women of childbearing potential)\n\n  12\\. Known hypersensitivity to any component of Pucotenlimab or Becotatug Vedotin (MRG003) (including histidine, histidine hydrochloride, sucrose, mannitol, and polysorbate 80), or a history of Grade ≥ 3 hypersensitivity reaction to any macromolecular protein preparation or monoclonal antibody\n\n  13\\. Serious infection (CTCAE Grade \\> 2) within 4 weeks prior to first dose, including but not limited to severe pneumonia, bacteremia, sepsis, or active tuberculosis\n\n  14\\. Pre-existing peripheral neuropathy of Grade \\> 1\n\n  15\\. Receipt of a live vaccine within 30 days prior to first dose of Becotatug Vedotin (MRG003)\n\n  16\\. Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT)\n\n  17\\. Any other condition judged by the investigator to potentially compromise patient safety or compliance, including but not limited to serious medical conditions requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory findings, or other psychological, familial, or social high-risk factors",{"count":201,"type":22},514,[172],"This randomized controlled trial aims to evaluate the efficacy and safety of Becotatug Vedotin (MRG003), an antibody-drug conjugate (ADC), combined with the PD-1 inhibitor Pucotenlimab as induction therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), compared to the standard gemcitabine and cisplatin (GP) regimen combined with Pucotenlimab, followed by concurrent chemoradiotherapy (CCRT) and adjuvant immunotherapy.",[205,56],"Nasopharyngeal Cancinoma (NPC)",[207,208,209,210,211],"PD-1 antibody","Antibody-Drug Conjugate","MRG003","Becotatug Vedotin","Pucotenlimab","2026-04-06",{"date":214,"type":91},"2026-04-13",{"date":216,"type":22},"2026-04",{"date":218,"type":22},"2032-04",{"name":220,"class":98},"Sun Yat-sen University",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":109,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100622550","phase-3-anlotinib-plus-immunotherapy-and-chemoradiotherapy-for-high-risk-nasopharyngeal-carcinoma-100622550","NCT07385079","Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma","A Randomized, Multicenter, Phase 3 Trial of Anlotinib Plus Immunochemoradiotherapy vs Immunochemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria\n\n1. Age ≥18 and ≤65 years\n2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.\n3. Tumor staged as T4N2 and T1-4N3 (AJCC 9th)\n4. Eastern Cooperative Oncology Group performance score of 0-11.\n5. Adequate marrow function: white blood cell count \\> 4 × 10⁹\u002FL hemoglobin \\>90g\u002FL and platelet count \\>100×10⁹\u002FL\n6. Adequate hepatic and renal function：\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN\n   * Alkaline phosphatase ≤ 2.5 × ULN\n   * clearance rate ≥ 60 ml\u002Fmin\n7. Other laboratory and clinical criteria\n\n   * Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)\n   * For patients aged \\>50 years with a history of smoking, normal pulmonary function test (PFT) results are required\n   * For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits\n8. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.\n9. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).\n\nExclusion Criteria\n\n1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1×103 copies\u002FmL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody\n2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).\n3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.\n4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.\n5. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.\n6. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \\>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.\n7. Uncontrolled cardiac conditions, such as:\n\n   * Heart failure with New York Heart Association (NYHA) classification ≥ Class II;\n   * Unstable angina;\n   * History of myocardial infarction within the past year;\n   * Supraventricular or ventricular arrhythmias requiring treatment or intervention\n8. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)\n9. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n10. Known hypersensitivity to macromolecule protein products or any component of benmelstobart.\n11. Active infections requiring systemic treatment within 1 week prior to enrollment.\n12. Administration of live vaccines within 30 days prior to the first dose of anlotinib hydrochloride.\n13. History of organ transplantation or hematopoietic stem cell transplantation.\n14. Presence of clinically significant bleeding symptoms or a definite hemorrhagic tendency; specifically, cases with a high risk of bleeding from local recurrence, or those within one year post-radiotherapy assessed to have a high risk of necrosis, must be excluded.\n15. History of hypertension that remains poorly controlled with medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).\n16. Urinalysis showing urine protein ≥ ++, confirmed by 24-hour urine protein quantification ≥1.0 g.\n17. Factors significantly affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea, or intestinal obstruction.\n18. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.","65 Years",{"count":230,"type":22},412,[172],"This trial aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC).",[205,56],[235,236,237],"anlotinib hydrochloride","PD-L1 antibody","chemoradiotherapy","2026-01-29",{"date":240,"type":91},"2026-02-03",{"date":242,"type":22},"2026-03-01",{"date":244,"type":22},"2030-01-01",{"name":220,"class":98},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":109,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":272},"100514817","phase-1-evaluate-bl-b01d1-in-patients-with-metastatic-or-unresectable-non-small-cell-lung-cancer-nsclc-and-other-solid-tumors-100514817","NCT05983432","Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors","A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung Cancer and Other Solid Tumors","Inclusion criteria:\n\n1. Signed the informed consent voluntarily and agreed to follow the program requirements\n2. Either sex\n3. Age: ≥18 years\n4. Has a life expectancy of ≥3 months\n5. Has histologically documented, incurable, locally advanced or metastatic epithelial origin malignant cancer, priority to include the following tumor types: NSCLC, HER2 - breast cancer, esophageal cancer, SCLC, NPC, and HNSCC.\n\n   Has documented locally advanced or metastatic HER2 negative (by immunohistochemistry \\[IHC\\], score of 0 or 1) Hormone Receptor (HR) positive (HER2-, HR+) OR HER2 negative (IHC score of 0 to 2) HR negative breast cancer (HER2-, HR-) as per ASCO CAP criteria (ASCO CAP 2023; Wolff et al. 2023), not amenable to curative surgery or radiation with documentation of radiological disease progression while on\u002Fafter receiving most recent treatment regimen for locally advanced or metastatic disease, must have received 1 prior line of chemotherapy for advanced disease and, when applicable and if approved in that region, a PD-1\u002FPD-L1 inhibitor, either given concurrently or sequentially. When appropriate, must have progression on at least 1 prior line of hormonal therapy with or without a targeted therapy (such as CDK4\u002F6, mTOR, or PI3-K inhibitors) administered for treatment of metastatic disease.\n\n   In Dose Escalation and Dose finding portions of the study, for triple-negative breast cancer (TNBC, HER2-\u002FHR-) participants must have received PARP inhibitors if a BRCA mutation is present and sacituzumab govitecan as second line treatment. Participants who are HER2 low must have received trastuzumab deruxtecan.\n6. Agree to provide archived tumor samples (tissue block or slides) from primary or metastatic sites within 2 years. In the event that no archival tissue is available a fresh tissue biopsy is highly encouraged but not mandatory.\n7. Has at least one measurable lesion based on RECIST V1.1 (with the exception of Prostate adenocarcinoma cohort, where subjects with bone metastasis are allowed)\n8. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1\n9. Toxicity of previous antitumor therapy has returned to level ≤1 as defined by NCI-CTCAE V5.0 (except for asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum or plasma amylase\u002Flipase, and elevated blood glucose; except for toxicity that the investigator determined to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.)\n10. Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n11. Has adequate organ function before registration, defined as: a) Marrow Function: Absolute neutrophil count (ANC) ≥1.2×109 \u002FL, Platelet count ≥100×109 \u002FL, Hemoglobin (Hb) ≥90 g\u002FL b) Hepatic function: Total bilirubin（TBIL≤1.5 ULN, AST and ALT without liver metastasis ≤2.5 ULN, AST and ALT with liver metastasis ≤5.0 ULN c) Renal function: Creatinine clearance ≥50 mL\u002Fmin (According to the Cockcroft and Gault equation)\n12. Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN\n13. Urinary protein ≤2+ or ≤1000mg\u002F24 hours\n14. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and for 7 months for females and 4 months for males after the last dose of study treatment. An additional contraceptive method, such as a barrier method like a condom is required.\n15. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female subjects are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\>45 years old in the absence of other biological or physiological causes. In addition, females \\\u003C55 years old must have a serum follicle stimulating hormone (fsh) level \\> 40 mIU\u002FmL to confirm menopause.\n16. For subjects with NSCLC (EGFR mutation):\n\n    a) Evidence of documented EGFR TKI-sensitizing deletion mutation in EGFR Exon 19 (ex19del) or leucin-arginine substitution point mutation in EGFR Exon 21 (ex21L858R), the serine-isoleucine mutation in EGFR Exon 20 (ex20S768I), the leucine-glutamine substitution mutation in Exon 21 (ex21L861Q), or the glycine substitution (with alanine, cysteine, or serine) mutation in Exon 18 (ex18G719X) at or after the time of disease diagnosis and prior to initiation of treatment.\n17. For Triple-Negative Breast Cancer (TNBC, HER2-\u002FHR-):\n\n    a) Histologically or cytologically confirmed and documented locally advanced, recurrent inoperable or metastatic TNBC\n18. For Esophageal adenocarcinoma\n\n    a) Has locally advanced or metastatic adenocarcinoma cell carcinoma of the esophagus or esophagogastric junction cancers, not amenable to curative surgery or radiation with documentation of radiological disease progression after one line of fluoropyrimidine and\u002For platinum-based chemotherapy treatment regimen for locally advanced or metastatic disease.\n\n    NOTE: Prior therapies such as trastuzumab, zolbetuximab, or IOs are allowed in the study.\n19. For Prostate adenocarcinoma\n\n    a) Subject has metastatic castration-resistant prostate cancer (mCRPC) after progression on\u002Fafter an androgen receptor pathway inhibitors (ARPI) treatment, such as abiraterone, enzalutamide, apalutamide and darolutamide.\n\n    Note: No prior chemotherapy including docetaxel is allowed Prior treatment with lutetium Lu 177 vipivotide tetraxetan (Pluvicto) is allowed. Enrollment will be capped for lutetium Lu 177 vipivotide tetraxetan-naive participants at approximately 20 or participants with prior lutetium Lu 177 vipivotide tetraxetan treatment at approximately 20.\n20. For NSCLC (EGFR wild type) with squamous histology\n\n    1. Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on\u002Fafter receiving most recent treatment regimen for locally advanced or metastatic disease with predominantly squamous cell histology\n    2. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1).\n    3. Progressed or intolerant to one line of platinum-based chemotherapy with α-PD-1\u002FL1 monoclonal antibody given either concurrently or sequentially.\n21. For NSCLC (EGFR wild type) with adenocarcinoma histology\n\n    1. Has documented locally advanced or metastatic NSCLC, not amenable to curative surgery or radiation with documentation of radiological disease progression while on\u002Fafter receiving most recent treatment regimen for locally advanced or metastatic disease with predominantly adenocarcinoma histology\n    2. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1).\n\n    Progressed or intolerant to one line of platinum-based chemotherapy with α-PD-1\u002FL1 monoclonal antibody given either concurrently or sequentially.\n22. Ovarian adenocarcinoma\n\n    a) Has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous platinum-containing chemotherapy with or without a PARP inhibitor.\n\n    Note: participants with platinum-sensitive or platinum resistant recurrent ovarian cancer (PSR) are eligible. However, enrollment will be capped for platinum-sensitive or platinum resistant participants at approximately 20 each.\n\n    Prior bevacizumab treatment is allowed.\n23. Endometrial carcinoma\n\n    a) Has relapsed, advanced and\u002For metastatic endometrial carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment\n24. For Cervical carcinoma Has relapsed, advanced and\u002For metastatic cervical carcinoma, who have progressed on or after prior platinum-based chemotherapy with or without immuno-oncology (IO) treatment\n\nExclusion criteria:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ Grade 2 heart failure, history of transmural myocardial infarction, unstable angina pectoris etc;\n3. Subjects with prolonged QT interval (QTc \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc., except for Type I diabetes, hypothyroidism that can be controlled only by standard of care treatment, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis)\n5. Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after radical resection\n6. Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure\\>150 mmHg or diastolic blood pressure\\>100 mmHg)\n7. Participants have Grade 3 lung disease defined according to NCI-CTCAE v5.0, a history of interstitial lung disease (ILD)\u002F pneumonitis\n8. Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring therapeutic intervention within the previous 6 months before screening; Infusion set-related thrombosis is excluded\n9. Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Participants on low dose corticosteroids (\\\u003C20 mg prednisone or equivalent\u002Fday) may participate.\n10. Participants who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-B01D1\n11. Participants have a history of autologous or allogeneic stem cell transplantation (Allo-HSCT)\n12. Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm2\n13. Participants with ≥ Grade 2 hypokalemia (low concentration of potassium in the blood) according to CTCAE v5.0 (Grade 1: participant asymptomatic with potassium levels \\\u003CLLN - 3.0 mmol\u002FL or equivalent)\n14. Known Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active Hepatitis B virus infection (HBV-DNA copy number\\> the lower limit of detection) or active Hepatitis C virus infection (HCV antibody positive and HCV-RNA \\> the lower limit of detection)\n15. Participants with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis.\n16. Received an investigational drug within 4 weeks, or two half-lives (whichever is longer) prior to first dose of study treatment\n17. Participants who are pregnant or breastfeeding\n18. Other conditions that the investigator believes may make the subject not suitable for participating in this clinical trial.\n19. Participants who have received prior therapy with any ADC targeting EGFR and\u002For HER3 or containing a topoisomerase 1 inhibitor payload (all dose expansion cohorts with exception of TNBC noted below).\n\n    Note: For TNBC dose expansion cohort, participants with prior ADC therapy targeting HER3 and EGFR or a topoisomerase I inhibitor, such as sacituzumab govitecan may be enrolled with Sponsor consultation prior to enrollment\n20. For NSCLC EGFRmut:\n\n    1. Participants treated with more than two systemic chemotherapies prior to randomization.\n\n       NOTE: Progression of disease within 12 months after receiving neoadjuvant and adjuvant chemotherapies is considered 1 prior systemic chemotherapy\n    2. Previously documented EGFR Exon 20 insertion mutations as primary EGFR mutations\n21. For Triple-Negative Breast Cancer (TNBC, HER2-\u002FHR-):\n\n    a) Participants treated with more than two systemic chemotherapies prior to randomization.\n\n    NOTE: Progression of disease within 12 months after receiving neoadjuvant and adjuvant chemotherapies is considered 1 prior systemic chemotherapy\n22. For Esophageal Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy therapy for locally advanced or metastatic disease. NOTE: this limit only applies to prior systemic chemotherapy.\n23. For Prostate adenocarcinoma:\n\n    a) Prior treatment with systemic chemotherapy.\n24. For NSCLC with EGFR WT squamous or adenocarcinoma histology: a) Participants received more than 1 prior line of systemic chemotherapy for locally advanced or metastatic disease\n25. For Ovarian Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.\n26. For Endometrial Carcinoma a) Participants received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy. Prior hormonal therapy is permitted.\n27. For Cervical Carcinoma a) if received more than 1 prior line of systemic chemotherapy. Re-treatment with platinum-based chemotherapy is considered one line of therapy.\n\nNotes: Re-treatment with platinum-based chemotherapy is considered one line of therapy.\n\nNote: A participant who does not meet this exclusion criterion may be allowed into the study pending the sponsor's approval, based on current accrual within this dose expansion cohort.\n\nNote: There is no limit on the number of prior lines of non-chemotherapy regimens. ADCs with cytotoxic payloads are considered a line of chemotherapy. For any expansion cohorts, if only limited number of patients can be enrolled with 1 prior line of chemotherapy, the Sponsor has the option to allow participants with more than 1 prior line of chemotherapy to be enrolled, upon Sponsor's approval.",{"count":254,"type":22},470,[142],"The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.",[258,29,65,30,259,56,260,261,71,72,179,262],"Non Small Cell Lung Cancer","Small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Prostate Adenocarcinoma","Triple Negative Breast Cancer","2026-01-28",{"date":238,"type":91},{"date":266,"type":91},"2023-08-08",{"date":268,"type":22},"2028-03-21",{"name":270,"class":271},"SystImmune Inc.","INDUSTRY",39,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":228,"enrollmentInfo":280,"targetDuration":4,"studyType":109,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":4},"100621697","phase-3-short-course-tislelizumab-combined-with-chemoradiotherapy-for-nasopharyngeal-carcinoma-100621697","NCT07373990","Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma","Short-course Tislelizumab Combined With Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized, Controlled, Multicenter, Phase 3 Non-inferiority Clinical Trial","Inclusion Criteria:\n\n1. Age ≥18 and ≤65 years\n2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.\n3. Eastern Cooperative Oncology Group performance score of 0-1.\n4. Tumor staged as T4N1 and T1-4N2-3 disease (AJCC 9th edition).\n5. Adequate marrow function:\n\n   white blood cell count \\> 4 × 10⁹\u002FL hemoglobin \\>90g\u002FL and platelet count \\>100×10⁹\u002FL\n6. Adequate hepatic and renal function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN), Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN, Alkaline phosphatase ≤ 2.5 ×ULN, clearance rate ≥ 60 ml\u002Fmin 7. Other laboratory and clinical criteria Normal: thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG); For patients aged \\>50 years with a history of smoking, normal pulmonary function test (PFT) results are required; For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits.\n\n8\\. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.\n\n9\\. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1×10 copies\u002FmL, positive for anti-hepatitis C virus (HCV) antibody, positive for anti-hepatitis C virus (HCV) antibody\n2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).\n3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received con dirmed and regular anti-tuberculosis treatment.\n4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.\n5. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.\n6. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \\>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.\n7. Uncontrolled cardiac conditions, such as: Heart failure with New York Heart Association (NYHA) classi dication ≥ Class II; or Unstable angina; or History of myocardial infarction within the past year; or Supraventricular or ventricular arrhythmias requiring treatment or intervention\n8. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)\n9. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n10. Known hypersensitivity to macromolecule protein products.\n11. Active infections requiring systemic treatment within 1 week prior to enrollment.\n12. Administration of live vaccines within 30 days prior to the first dose of tile.\n13. History of organ transplantation or hematopoietic stem cell transplantation.\n14. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.\n15. Patients who have previously received immune checkpoint (CTLA-4, PD-1, PD-L1, etc.) inhibitor therapy.",{"count":281,"type":22},418,[172],"This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.",[205,56],[286,207,287],"tislelizumab","short-course","2026-01-20",{"date":263,"type":91},{"date":291,"type":22},"2026-01-15",{"date":293,"type":22},"2030-12-31",{"name":220,"class":98},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":302,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":109,"phases":306,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":131},"100462704","phase-2-randomised-trial-of-induction-gemcitabine-and-cisplatin-versus-gemcitabine-cisplatin-pembrolizumab-and-bevacizumab-gppb-in-nasopharyngeal-cancer-100462704","NCT05305131","Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer","Phase II Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer","Inclusion Criteria:\n\n1. The participant (or legally acceptable representative if applicable) provides written consent for the trial.\n2. Participants who are at least 21 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of non-keratinizing nasopharyngeal carcinoma (NPC).\n3. Have measurable disease based on RECIST 1.1.\n4. Tumour stage III (except for T3N0 and T3N1) or IVA according to the American Joint Committee on Cancer (AJCC) 8th edition criteria.\n5. Have locally or centrally determined EBV-positive NPC by EBV-encoded small RNA in situ hybridization (EBER in situ hybridization \\[ISH\\]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required.\n\n   Note: If EBV status by EBER ISH assay has not been previously determined, tumor tissue from archival tissue may be submitted for EBV determination.\n6. Did not receive any prior treatment\n7. Willingness to donate blood for mandatory translational research studies.\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n9. Have an adequate organ function\n10. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 of study protocol OR\n    2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 of study protocol during the treatment period and for at least 120 days after the last dose of study medication.\n11. A male participant must agree to use a contraception as detailed in Appendix 3 of study protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n1. Stage III NPC with T3N0 or T3N1 staged by AJCC 8th edition\n2. Has received prior systemic anti-cancer therapy including chemotherapy, radiotherapy, immunotherapy or investigational agents\n3. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.\n4. Has a condition requiring systemic steroid therapy (\\> 10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Inhaled or topical steroids and adrenal replacement doses \\\u003C10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \\\u003C or = 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.\n5. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.\n6. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n7. Has hypersensitivity to bevacizumab or any of its components.\n8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n   Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.\n9. Has an active infection requiring systemic therapy, or serious non-healing wound, ulcer or bone fracture.\n10. Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of = 3 anti-hypertensive drugs or systolic blood pressure greater than 150 mmHg).\n11. History of cardiac disease: congestive heart failure \\> New York Heart Association (NYHA) Class II; active coronary artery disease (unstable angina \\[anginal symptoms at rest\\] or new-onset angina \\[began within the last 3 months\\] or myocardial infarction within the past 6 months). Cardiac arrhythmias requiring anti-arrhythmic therapy (ß-blockers or digoxin are permitted).\n12. Persistent proteinuria of NCI-CTCAE Grade 3 or higher (\\> 3.5 g\u002F24 hours, measured by urine protein\u002Fcreatinine ratio on a random urine sample).\n13. Clinically significant bleeding (NCI-CTCAE Grade 3 or higher) within 30 days prior to start of study medication.\n14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n16. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.\n17. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization\u002Fallocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n    Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.\n18. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.\n19. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\n    Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n20. Has received a live vaccine within 30 days of prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine.\n\nNote: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.","21 Months","99 Years",{"count":305,"type":22},50,[171],"The investigators hypothesize that the addition of bevacizumab and pembrolizumab to induction cisplatin and gemcitabine is tolerable and improves metabolic complete response (mCR), relapse free survival (RFS) and overall survival (OS) compared to induction cisplatin and gemcitabine in patients with locally advanced nasopharyngeal cancer (NPC)",[56],[310,311,312,313,314],"gemcitabine","cisplatin","pembrolizumab","bevacizumab","GPPB","2025-09-21",{"date":317,"type":91},"2025-09-23",{"date":319,"type":91},"2022-03-28",{"date":321,"type":22},"2026-12-28",{"name":323,"class":98},"National University Hospital, Singapore",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":17,"minAge":330,"maxAge":303,"enrollmentInfo":331,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":131},"100388605","discovery-of-biomarkers-for-intrinsic-radiation-sensitivity-in-cancer-patients-100388605","NCT04340024","Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients","Inclusion Criteria:\n\n* Patients with severe side effects from radiotherapy\n* Patients with a type of cancer that is associated with sensitivity to radiotherapy\n\nExclusion Criteria:\n\n* Age of patient must be between 21 (inclusive) and 99 (exclusive)","21 Years",{"count":332,"type":22},5000,"Patients with cancers that are sensitive to radiotherapy treatment and\u002For patients who have experienced severe acute\u002F late side effects to radiotherapy will be recruited to the study. Blood and\u002For matched tumour-normal tissue pairs will be collected. Blood and\u002For tissue samples will be processed and studied for genetic and biochemical markers that have potential to be used for predicting sensitivity to radiation.",[56,48,335],"Other Cancer",[337,338,339,340,341],"Radiotherapy","Biomarkers","Genomics","Immunomics","Precision medicine","2025-06-10",{"date":344,"type":91},"2025-06-11",{"date":346,"type":91},"2015-09-30",{"date":348,"type":22},"2026-12-31",{"name":350,"class":98},"National Cancer Centre, Singapore",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":228,"enrollmentInfo":358,"targetDuration":4,"studyType":109,"phases":360,"briefSummary":361,"conditions":362,"keywords":363,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":5},"100573716","phase-3-ql1706-pd-1ctla-4-bi-specific-antibody-and-chemoradiotherapy-in-locoregionally-advanced-nasopharyngeal-carcinoma-100573716","NCT06749899","QL1706 (PD-1\u002FCTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.","QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1\u002F CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma：A Randomized, Controlled, Multicenter Phase III Clinical Study.","Inclusion Criteria\n\n1. Age ≥18 and ≤65 years\n2. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma according to WHO criteria.\n3. Tumor staged as T4N1 and T1-4N2-3 (AJCC 9th)\n\n   * Stage II: T1-3N2\n   * Stage III: T1-4N3, T4N1-2\n4. Eastern Cooperative Oncology Group performance score of 0-11.\n5. Adequate marrow function: white blood cell count \\> 4 × 10⁹\u002FLhemoglobin \\>90g\u002FL and platelet count \\>100×10⁹\u002FL\n6. Adequate hepatic and renal function：\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×ULN\n   * Alkaline phosphatase ≤ 2.5 × ULN\n   * clearance rate ≥ 60 ml\u002Fmin\n7. Other laboratory and clinical criteria\n\n   * Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests and electrocardiogram (ECG)\n   * For patients aged \\>50 years with a history of smoking, normal pulmonary function test (PFT) results are required\n   * For patients with abnormal ECG findings or a prior history of cardiovascular disease (not meeting any exclusion criteria listed in Item 8), additional assessments including myocardial function evaluation and cardiac ultrasound (echocardiography) must be performed, with results within normal limits\n8. Patients must be informed of the investigational nature of this study and give written informed consent, and be willing and able to comply with the study schedule, including follow-up visits, treatment procedures, laboratory testing, and other protocol-related requirements.\n9. Women of childbearing potential (WOCBP) must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug (e.g., condoms, physician-guided regular use of oral contraceptives).\n\nExclusion Criteria\n\n1. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1×103 copies\u002FmL, positive for anti-hepatitis C virus (HCV) antibody , positive for anti-hepatitis C virus (HCV) antibody\n2. Positive for anti-HIV antibody or diagnosed with acquired immunodeficiency syndrome (AIDS).\n3. Active pulmonary tuberculosis: Patients with a history of active tuberculosis within the past year should be excluded regardless of treatment status. Patients with a history of active pulmonary tuberculosis more than one year prior should also be excluded, unless they received confirmed and regular anti-tuberculosis treatment.\n4. Active, known, or suspected autoimmune diseases, including but not limited to uveitis, colitis, hepatitis, hypophysitis, nephritis, vasculitis, systemic lupus erythematosus, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilators. Type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.\n5. Thymic epithelial tumors (TETs), including thymoma, thymic carcinoma, and thymic neuroendocrine tumors (NETTs).\n6. History of interstitial lung disease or pneumonia requiring oral or intravenous corticosteroids within the past year; use of vancomycin within the past month.\n7. Ongoing chronic systemic corticosteroid therapy (equivalent to or greater than prednisone \\>10mg per day) or any other immunosuppressive therapy. Patients received inhale or topical corticosteroid are allowed.\n8. Uncontrolled cardiac conditions, such as:\n\n   * Heart failure with New York Heart Association (NYHA) classification ≥ Class II;\n   * Unstable angina;\n   * History of myocardial infarction within the past year;\n   * Supraventricular or ventricular arrhythmias requiring treatment or intervention\n9. Pregnant or breastfeeding women (pregnancy testing should be considered for women of childbearing potential with active sexual life)\n10. History or presence of other malignancies, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n11. Known hypersensitivity to macromolecule protein products or any component of QL1706.\n12. Active infections requiring systemic treatment within 1 week prior to enrollment.\n13. Administration of live vaccines within 30 days prior to the first dose of epalurilimab-tovorolimab.\n14. History of organ transplantation or hematopoietic stem cell transplantation.\n15. Any other condition assessed by the investigator as potentially compromising patient safety or compliance, such as severe illnesses requiring urgent treatment (including psychiatric disorders), significantly abnormal laboratory values, or other psychological, familial, or social risk factors.",{"count":359,"type":22},580,[172],"The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).",[205,56],[364,365,366],"Immunotherapy","PD-1\u002FCTLA-4 Bi-specific Antibody","Chemoradiotherapy","2025-05-19",{"date":369,"type":91},"2025-05-22",{"date":371,"type":91},"2025-05-04",{"date":373,"type":22},"2030-12-01",{"name":375,"class":98},"Sun Yat-Sen University Cancer Center",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":109,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100429710","phase-2-nivolumab-in-nasopharyngeal-cancer-with-progression-during-or-after-platinum-based-treatment-100429710","NCT04875611","Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment","Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy","NIVONASO-21","Inclusion Criteria:\n\n1. Age \\> 18 years old\n2. Histological or cytological documentation of squamous cell carcinoma.\n3. Primary tumor location in nasopharynx\n4. Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy\n5. Tumor recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy\n6. ECOG(Eastern Cooperative Oncology Group) performance scale 0-1\n7. Participant is willing and able to give informed consent for participation in the study and agrees to undergo all follow up visit and planned procedures.\n\nExclusion Criteria:\n\n1. Known active central nervous system metastases.\n2. Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) \\\u003C 30 ml\u002Fmin\u002Fm2\n3. Presence of liver disfunction, defined as level of AST(aspartate aminotransferase) and \u002For ALT(alanine aminotransferase) \\> 2,5 x ULN(upper limits of normal) (\\> 5 x ULN in patients with documented liver metastases); total bilirubin \\> 1,5 xULN ( bilirubin \\> 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \\\u003C 35%) or albumin \\\u003C 2,5 g\u002FdL\n4. Abnormalities in blood count such as: hemoglobin \\\u003C 9 g\u002Fdl, platelets \\\u003C 100 x 109 \u002FL, Absolute Neutrophil Count (ANC) \\\u003C1,0 x 109 \u002FL\n5. Ejection fraction in echocardiography \\\u003C 50%\n6. History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.\n7. Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.\n8. Pregnancy or breastfeeding.\n9. Female with childbearing potential or male participant with female partner of childbearing potential, who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period and for 5 months after the end of treatment (last infusion)\n10. Prior therapy with an anti-PD-1\u002FL1\u002FL2 and\u002For anti-ICOS directed agent\n11. Patient is currently participating in another clinical trial.\n12. Active infection, which significantly affects the patient's clinical condition and requires treatment.\n13. Patient with prior bone marrow or solid organ transplantation.\n14. Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent \\> 10 mg)\n15. Known immunodeficiency including HIV\u002FAIDS(human immunodeficiency virus\u002Facquired immunodeficiency syndrome) infection.\n16. Patient received any live vaccine within 28 days before enrollment.\n17. Heart Failure - NYHA(New York Heart Association functional classification system) III or IV\n18. Coexistence of active malignant tumor or history of malignant tumor after radical treatment with disease-free period \\> 2 years, except: cervical cancer in situ\u002F basocellular skin cancer\u002Fprostate cancer, after radical treatment.\n19. Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.",{"count":385,"type":22},32,[171],"Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32.",[56],"2025-04-21",{"date":391,"type":91},"2025-04-24",{"date":393,"type":91},"2021-08-26",{"date":395,"type":22},"2025-12-31",{"name":397,"class":98},"Maria Sklodowska-Curie National Research Institute of Oncology",4,{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":228,"enrollmentInfo":406,"targetDuration":4,"studyType":109,"phases":407,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":398},"100542978","phase-2-adebrelimab-and-chemoradiotherapy-in-high-risk-lanpc-100542978","NCT06349889","Adebrelimab and Chemoradiotherapy in High-risk LANPC","Adebrelimab Combined with Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 2, Multicenter, Single-arm Clinical Trial","Inclusion Criteria:\n\n1. Patients with histologically confirmed nasopharyngeal carcinoma.\n2. Tumor staged as IVA+T3N2M0 (AJCC 8th).\n3. Eastern Cooperative Oncology Group performance status ≤1.\n4. Adequate marrow function: neutrocyte count≥1.5×10e9\u002FL, hemoglobin ≥90g\u002FL and platelet count ≥100×10e9\u002FL.\n5. Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.\n6. Adequate renal function: creatinine clearance rate ≥ 60 ml\u002Fmin (Cockcroft-Gault formula).\n7. Patients must be informed of the investigational nature of this study and give written informed consent.\n8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug\n\nExclusion Criteria:\n\n1. Age \\> 65 or \\\u003C 18.\n2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \\>1×10e3 copies\u002Fml or 200IU\u002Fml\n3. Hepatitis C virus (HCV) antibody positive\n4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).\n5. Has any condition that required systemic corticosteroid (equivalent to prednisone \\>10mg\u002Fd) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg\u002Fd, inhale or topical corticosteroid will be allowed.\n6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.\n7. Has a known history of interstitial lung disease.\n8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.\n9. Is pregnant or breastfeeding.\n10. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.\n11. Has known allergy to large molecule protein products or any compound of Adebrelimab.\n12. Has a known history of human immunodeficiency virus (HIV) infection.\n13. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic\u002Fsocial factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.",{"count":305,"type":22},[171],"This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).",[114,56],[411,366,412],"immunotherapy","PD-L1","2025-01-13",{"date":415,"type":91},"2025-01-15",{"date":417,"type":91},"2024-07-23",{"date":419,"type":22},"2028-05-01",{"name":220,"class":98},{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":4,"enrollmentInfo":429,"targetDuration":431,"studyType":24,"phases":4,"briefSummary":432,"conditions":433,"keywords":439,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":131},"100567034","arabic-pro-measures-for-head-and-neck-cancer-radiotherapy-100567034","NCT06662929","Arabic PRO Measures for Head and Neck Cancer Radiotherapy.","Arabic Patient-reported Outcome Measures During Radiotherapy for Head and Neck Cancer: a Validation Study","PROMs","Inclusion Criteria:\n\n* Adults aged 18 or above and who is planned for receiving and who is currently receiving and who had already received radiotherapy for the HNC at King Saud University Medical City.\n\nExclusion Criteria:\n\n* Individuals who are less than 18 years, presence of debilitating disease (e.g. heart failure) or who lack the capacity to read, understand and sign the informed consent and those.",{"count":430,"type":22},125,"2 Weeks","The goal of Arabic patient-reported outcome measures during radiotherapy for head and neck cancer is to test the patient-reported outcome measure (PROM) tools. PROM tools are not validated cross-culturally in Arabic-speaking patient populations, which limits their use in our clinical setting. Validation of these PROM tools will allow clinicians to identify the concerns related to our patient population and measure the outcome of our interventions. Main objectives are:\n\n* To further validate (cross-culture) the PROM instruments related to head and neck cancer (HNC) in Arabic patients.\n* To investigate the prevalence and severity of the patient-reported concerns and their relevance with demographics and clinical characteristics.\n\nThe participants will be given tasks to complete 6 tools survey before, during, and after radiotherapy.",[180,434,260,435,56,436,437,438],"Head and Neck Neoplasms","Oropharynx Cancer","Oral Cancer","Tongue Cancer","Oral Neoplasm",[427,180,337,440,441],"COSMIN","Cancer","2024-10-26",{"date":444,"type":91},"2024-10-29",{"date":446,"type":91},"2023-05-01",{"date":448,"type":22},"2025-10-01",{"name":450,"class":98},"King Saud University",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":16,"sex":17,"minAge":106,"maxAge":167,"enrollmentInfo":457,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":459,"conditions":460,"keywords":467,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":305},"100488296","a-multicentre-study-on-features-of-the-gut-microbiota-of-patients-with-critical-chronic-diseases-in-china-100488296","NCT05638269","A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China","Inclusion Criteria:\n\n1. aged 18-75 years;\n2. living in the province where the hospital is located in the last three years;\n3. with a medical diagnosis of one of the target diseases;\n4. willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. female in pregnancy or lactation(unless the subject is pregnant women);\n2. with medical diagnoses of other serious illnesses;\n3. with a history of bariatric surgery or intestinal resection, except for appendectomy；\n4. individual who was treated with drugs in the preceding 1 month, including antibiotics, metformin, statins, acid inhibitor, probiotics, and probiotics; individuals having consumed yogurt more than 3 times in the preceding 1 month; heavy drinkers who have consumed more than 4 taels of liquor or 1000ml of beer; frequent alcohol consumers who have drunk per week in the last month.",{"count":458,"type":22},12000,"The human gut microbiome has been associated with many health factors but variability between studies limits the exploration of effects between them. This study aims to systematically characterize the gut microbiota of various critical chronic diseases, compare the similarities and differences of the microbiome signatures linked to different regions and diseases, and further investigate their impacts on microbiota-based diagnostic models.",[461,40,56,27,29,462,463,464,39,465,466],"Essential Hypertension","Chronic Kidney Diseases","Acute Coronary Syndrome","Epilepsy","Primary Aldosteronism","Subclinical hypothyroïdism",[468,469,470,471,472,473],"cardiovascular disease","exctracoonic cancer","nervous system diseases","endocrine diseases","urological diseases","microbial dysbiosis","2024-07-26",{"date":476,"type":91},"2024-07-29",{"date":478,"type":91},"2022-03-01",{"date":480,"type":22},"2025-12",{"name":482,"class":98},"Zhujiang Hospital",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":17,"minAge":491,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":4},"100553039","exploratory-study-of-ebv-dna-titre-clearance-whilst-on-proton-beam-therapy-100553039","NCT06480903","Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy","Exploratory Study of Plasma Epstein Barr Virus (EBV) DNA Clearance During Proton Beam Therapy (PBT) for Nasopharyngeal Carcinoma (NPC)","ClearED","Inclusion Criteria:\n\n* Children and young adults (8-30 years old)\n* Pathologically confirmed EBV-positive nasopharyngeal carcinoma\n* Stage I-IVA (AJCC 8th Edition)\n* Planned to commence curative-intent radiation therapy\n\nExclusion Criteria:\n\n* Recurrent NPC\n* Concurrent or previously treated EBV-associated malignancy\n* Prior radiation therapy\n* Contraindications to MRI\n* General anaesthetic requirement for MRI","8 Years","30 Years",{"count":494,"type":22},10,"How does plasma Epstein-Barr Virus (EBV) DNA level change during definitive radiation therapy for nasopharyngeal carcinoma (NPC) in the teenage and young adult cohort and does it correlate with outcomes?",[114,180,56,497],"Epstein-Barr Virus",[499],"Nasopharyngeal, cancer, proton beam, epstein-barr virus","2024-06-25",{"date":502,"type":91},"2024-06-28",{"date":504,"type":22},"2024-08-30",{"date":506,"type":22},"2026-08-30",{"name":508,"class":98},"The Christie NHS Foundation Trust",{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":17,"minAge":517,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":109,"phases":520,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":539},"100517560","phase-2-nivolumab-in-children-and-adults-with-nasopharyngeal-carcinoma-100517560","NCT06019130","Nivolumab in Children and Adults With Nasopharyngeal Carcinoma","Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma","NPC-Nivo","Inclusion Criteria:\n\n1. Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged between 3 years and 17 years, OR histologically confirmed new diagnosis of EBV-positive nasopharyngeal carcinoma, WHO stage II or III, in subjects ≥ 18 years\n2. Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients \\> 25 years of age (AJCC, 8th edition)\n3. Measurable disease by MRI per RECIST 1.1 criteria\n4. Sufficient tumor tissue to be sent for central review, including PD-L1 staining, either as 1 or 2 full blocks (preferred) or a minimum of 25 slides, obtained from core biopsy, punch biopsy, excisional biopsy or surgical specimen\n5. Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation\n\nExclusion Criteria:\n\n1. Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients \\> 25 years of age\n2. Recurrent nasopharyngeal carcinoma\n3. Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and\u002For radiotherapy\n4. Prior chemotherapy and\u002For radiotherapy\n5. Other active malignancy\n6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n7. The subject received an investigational drug within 30 days prior to inclusion into this study\n8. Subjects who are enrolled in another clinical trial\n9. Subjects with prior organ allograft or allogenic bone marrow transplantation\n10. Subjects with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.\n11. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before start of therapy. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n12. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n13. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n14. Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values:\n\n    1. WBC \\\u003C 2 000\u002Fµl\n    2. Neutrophils \\\u003C 1 500\u002Fµl\n    3. Platelets \\\u003C 100 x 10e3\u002FµL\n    4. Hemoglobin \\\u003C 9.0 g\u002FdL\n    5. Creatinine \\>1.5 x ULN or creatinine clearance \\\u003C 50 mL\u002Fmin (using the Cockcroft Gault formula or Schwartz formula in patients \\\u003C 18 years)\n    6. AST\u002FALT \\> 3 x ULN (\\> 5 x ULN if liver metastases)\n    7. Total Bilirubin \\> 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 x ULN)\n15. Hearing loss \\> 20 dB loss at 3 kHz due to an inner ear disorder and not caused by tumour burden\n16. History of allergy or hypersensitivity to platinum-containing compounds or other study drug components\n17. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).\n18. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug.\n19. Adequate performance status (Karnofsky score ≥ 60 for patients (age ≥ 16), Lansky score ≥ 60 (age \\\u003C 16).\n20. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.\n21. The subject has any current or past medical condition and\u002For required medication to treat a condition that could affect the evaluation of the study.\n22. Pregnant females as determined by positive \\[serum or urine\\] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol. (Please refer to section 4.4)\n23. Lactating females\n24. Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities\n25. The subject is unwilling or unable to follow the procedures outlined in the protocol\n26. The subject is mentally or legally incapacitated.","3 Years",{"count":519,"type":22},57,[171],"The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.",[114,56,523,146],"Nasopharyngeal Neoplasms",[364,525,526,527,528,529],"Nivolumab","Children","Adults","Chemotherapy","Immune Checkpoint Inhibitor","2024-05-14",{"date":532,"type":91},"2024-05-16",{"date":534,"type":91},"2023-01-10",{"date":536,"type":22},"2028-01-09",{"name":538,"class":98},"German Society for Pediatric Oncology and Hematology GPOH gGmbH",31,{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":547,"enrollmentInfo":548,"targetDuration":4,"studyType":109,"phases":550,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":131},"100487579","phase-2-modulation-therapy-for-locally-advanced-npc-based-on-plasma-ebv-dna-level-post-ict-100487579","NCT05628922","Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT","Response-adapted Modulation Therapy for Locally Advanced Nasopharyngeal Carcinoma Based on Circulating Epstein-Barr Virus DNA Level Post Induction Chemotherapy","Inclusion Criteria:\n\n1. Subjects must sign the informed consent form, and must be willing and able to comply with the visits, treatment regimen, laboratory tests and other requirements specified in the study protocol;\n2. Age at diagnosis: 18-70 years old;\n3. Firstly diagnosed, pathologically confirmed primary nasopharyngeal carcinoma with \"non-keratinizing carcinoma (WHO criteria)\";\n4. Locally advanced nasopharyngeal carcinoma (T3-4N0-1M0, TanyN2-3M0), staged according to the American Joint Committee on Cancer (AJCC) 8th edition clinical staging system;\n5. Pretreatment EBV DNA \\>0;\n6. ECOG score: 0-1 points;\n7. Does not receive any treatment after the diagnosis of nasopharyngeal carcinoma;\n8. Normal bone marrow function: white blood cell \\>4\\*109\u002FL, neutrophil count \\>1.5\\*109\u002FL, hemoglobin concentration \\> 90g\u002FL, platelet count \\>100\\*109\u002FL;\n9. Normal liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal; aspartate aminotransferase and\u002For alanine aminotransferase ≤ 2.5 times the upper limit of normal; creatinine clearance ≥ 60mL\u002Fmin;\n10. For those with hepatitis B infection, the HBV DNA load must be \\\u003C 2500 copies\u002Fml at the time of screening; For those with anti-hepatitis C virus antibody, HCV RNA must be negative at the time of screening;\n11. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use reliable contraception (e.g. condoms, regular contraceptives as directed) from screening through 1 year after treatment.\n\nExclusion Criteria:\n\n1. Pathologically confirmed primary nasopharyngeal carcinoma with \"keratinizing carcinoma or basaloid squamous cell carcinoma\";\n2. Previous or current other malignancy other than adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma;\n3. Pretreatment plasma EBV DNA undetectable;\n4. History of radiation therapy prior to standard therapy (except for non-melanoma skin cancer, and the previous radiation field did not overlap with the current treatment for nasopharyngeal carcinoma);\n5. Patients who received surgical treatment (except for diagnostic biopsy), biological therapy, chemotherapy or immunotherapy before enrollment;\n6. Conditions mentioned below: 1) Currently enrolled in other interventional clinical trial; 2) Systemic hormonal or other immunosuppressive therapy with an equivalent dose of \\> 10mg prednisone\u002Fday within 28 days prior to informed consent; 3) Receipt of live vaccines within 30 days prior to enrollment; 4) Surgery or trauma within 30 days prior to enrollment;\n7. Uncontrolled heart disease, such as :1) heart failure, NYHA ≥ 2; 2) unstable angina; 3) history of myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention;\n8. History of stroke within 6 months;\n9. Patients with severe active infection within 30 days prior to enrollment, that must be treated with systemic antibacterial, antifungal or antiviral therapy;\n10. Active autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, etc.). Except for type I diabetes, hypothyroidism requiring hormone replacement therapy, and vitiligo not requiring systemic treatment, inactive childhood asthma that does not require treatment as an adult;\n11. Positive anti-HIV antibody or diagnosis of other innate or acquired immunodeficient, immunosuppressive disease, history of organ transplantation;\n12. Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year;\n13. Active tuberculosis infection, or previous lung tuberculosis infection within 1 year, or previous lung tuberculosis infection more than 1 year prior to enrollment but did not receive standard anti-tuberculosis treatment;\n14. Positive hepatitis B surface antigen and hepatitis B virus DNA ≥ 2500 copies\u002Fml or Positive hepatitis C RNA;\n15. Pregnant or lactating women (pregnancy test should be considered for sexually active women of childbearing age);\n16. Other conditions that may jeopardize patient safety or compliance as assessed by investigator, such as serious illness (including psychiatric disorders) requiring prompt treatment, severely abnormal test results, and other family or social risk factors.","70 Years",{"count":549,"type":22},198,[171],"Nasopharyngeal carcinoma is biologically different from traditional head and neck squamous cell carcinoma. The mainstay treatment for locally advanced nasopharyngeal carcinoma is cisplatin-based concurrent chemoradiation. Recent phase III randomized control trials have demonstrated that induction chemotherapy plus concurrent chemoradiation further improved progression-free survival.\n\nHowever, not every patient has good response to induction chemotherapy. Evidence has accumulated that those with poor response to induction chemotherapy, or those with detectable Epstein-Barr Virus (EBV) DNA post induction chemotherapy, correlated with poorer progression-free survival. Huang CL et al. (Int J Radiat Oncol Bio Phys. 2019) reported that plasma EBV DNA load at completion of induction chemotherapy was an independent and earlier predictor for progression-free survival and overall survival in locally advanced nasopharyngeal carcinoma. Lv J et al. (Nat Commun. 2019) demonstrated that real-time monitoring of plasma EBV DNA response added prognostic information, and had the potential uitility for risk-adapted treatment intensification in nasopharyngeal carcinoma.\n\nTherefore, investigators selects those with poor plasma EBV DNA response during and after induction chemotherapy, and intensifies the treatment with combination of anti-PD-1 antibody, in order to improve progression-free survival in locally advanced nasopharyngeal carcinoma, according to response-adapted strategy.",[56],[554,364,555,556],"Epstein-Barr virus DNA","Programmed Cell Death 1 antibody","Induction chemotherapy","2022-11-25",{"date":559,"type":91},"2022-11-29",{"date":561,"type":91},"2022-07-02",{"date":563,"type":22},"2027-07-01",{"name":565,"class":98},"Fudan University",{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":547,"enrollmentInfo":573,"targetDuration":4,"studyType":109,"phases":575,"briefSummary":576,"conditions":577,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":587},"100397338","phase-3-concurrent-and-adjuvant-pd1-treatment-combined-with-chemo-radiotherapy-for-high-risk-nasopharyngeal-carcinoma-100397338","NCT04453826","Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma","A Multicenter Randomized Clinical Phase 3 Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).\n2. Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).\n3. Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD\u002FPD according to RECIST criteria or EBV DNA of \\>0 copies\u002FmL after 3 cycles of GP induction chemotherapy.\n4. Aged between 18-70 years.\n5. Karnofsky scale (KPS)≥70.\n6. Normal bone marrow function.\n7. Normal liver and kidney function:\n\n   1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;\n   2. creatinine clearance rate of at least 60 mL\u002Fmin or creatinine of no more than 1.5 times the upper normal limit.\n8. Given written informed consent.\n\nExclusion Criteria:\n\n1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.\n2. Recurrent or metastatic nasopharyngeal carcinoma.\n3. Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies\u002FmL after 3 cycles of GP induction chemotherapy.\n4. Has known allergy to large molecule protein products or any compound of study therapy.\n5. Has known subjects with other malignant tumors.\n6. Has any active autoimmune disease or history of autoimmune disease.\n7. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.\n8. The laboratory examination value does not meet the relevant standards within 7 days before enrollment\n9. Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.\n10. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.\n11. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.\n12. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.\n13. Has a known history of human immunodeficiency virus (HIV).\n14. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps\u002Fml or hepatitis C virus (HCV) antibody positive.\n15. Has received a live vaccine within 4 weeks of planned start of study therapy.\n16. Pregnancy or breast feeding.",{"count":574,"type":22},388,[172],"Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.",[56,528,337,578],"PD-1 Therapy","2020-09-24",{"date":581,"type":91},"2020-09-28",{"date":583,"type":91},"2020-09-01",{"date":585,"type":22},"2028-09",{"name":220,"class":98},6]