[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-squamous-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-squamous-cell":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,79,92,124,154,185,213,240,262,286,321,347,374,402,426],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100053960","phase-1-intratumoral-n17350-in-advanced-solid-tumors-100053960",false,"NCT07339176","Intratumoral N17350 in Advanced Solid Tumors","A Phase 1\u002F2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors","OP-NEU-101","Inclusion Criteria:\n\n1. Age ≥18 years (or legal age of consent in the study jurisdiction).\n2. Able to provide written informed consent and willing\u002Fable to comply with study procedures, visits, and follow-up.\n3. Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.\n4. ECOG performance status 0-1.\n5. Measurable disease per IT-RECIST (Parts A1\u002FA2) and RECIST v1.1 (Part A3), as applicable.\n6. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe\u002Faccessible for injection:\n\n   1. Superficial lesions: ≥10 mm in longest diameter (or multiple lesions each ≥5 mm with aggregate longest diameter ≥10 mm), and ≤80 mm, accessible for direct injection (± ultrasound guidance).\n   2. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection.\n   3. Injected lesions must not involve\u002Fencase major blood vessels or otherwise pose an unacceptable bleeding\u002Fvascular risk, per investigator assessment and imaging review (as applicable).\n   4. Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection.\n7. Adequate recovery from prior therapy: toxicities from prior anticancer treatment resolved to Grade ≤1 or baseline (except alopecia, controlled endocrine toxicities, or other stable toxicities as allowed per protocol\u002Fsponsor).\n8. Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds.\n9. Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds.\n10. Tumor tissue requirements: willingness to provide a pre-treatment tumor biopsy and on-study post-treatment biopsy, if an accessible lesion is available and safe for biopsy, and biopsy does not interfere with injection\u002Fresponse assessment; and\u002For availability of archival tumor tissue (obtained within 2 years prior to treatment), per protocol.\n11. Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy\u002Ffathering children from screening through 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose, per protocol.\n\nExclusion Criteria:\n\n1. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.\n2. History of solid organ transplant.\n3. Alpha-1 antitrypsin deficiency.\n4. Hereditary or acquired bleeding disorder\u002Fcoagulation factor deficiency.\n5. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol).\n6. Baseline QTcF \\>480 ms.\n7. Pregnant or breastfeeding.\n8. Prior severe immune-mediated adverse event (imAE) from immunotherapy: ≥Grade 3 imAE within the past 16 weeks, any Grade 4 life-threatening imAE, or any neurologic\u002Focular AE of any grade (except controlled endocrine AEs on stable replacement therapy per protocol).\n9. Another active malignancy (current or within the past 2 years) other than the disease under study, except specified low-risk cancers treated with curative intent or under active surveillance (per protocol).\n10. Recent anticancer therapy: receipt of systemic anticancer therapy (including investigational agents) within 2 weeks prior to first dose (or 4 weeks for monoclonal antibodies\u002FADCs\u002Fother long half-life biologics), or within 5 half-lives, whichever is shorter.\n11. Recent radiotherapy within 2 weeks prior to first dose.\n12. Unresolved toxicity from prior anticancer therapy to \\>Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol).\n13. Uncontrolled or unstable brain metastases (eligible only if neurologically stable for ≥4 weeks, and off steroids or on stable\u002Fdecreasing steroids ≤10 mg\u002Fday prednisone equivalent; carcinomatous meningitis excluded).\n14. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.\n15. Chronic viral infections not meeting protocol criteria:\n\n    1. HBV with detectable DNA unless on appropriate antiviral therapy\n    2. Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable)\n    3. HIV infection with CD4+ count \\\u003C300\u002FμL, detectable viral load, or HIV-related illness within 6 months\n16. Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose.\n17. Chronic systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent, or systemic immunosuppressive\u002Fanti-inflammatory medications within 4 weeks prior to first dose, except permitted topical\u002Finhaled\u002Flocal formulations or short courses for premedication per protocol.\n18. Known allergy\u002Fhypersensitivity to N17350 or any excipients.","ALL","18 Years",{"count":20,"type":21},275,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies.\n\nThe main questions it aims to answer are:\n\n1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?\n2. Are there any side effects for participants when taking N17350?\n3. What is the safest dose of N17350 and the dose that should be used for further study?\n4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo.\n\nParticipants will:\n\n1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks\n2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects\n3. Have imaging scans (such as CT or MRI) to measure tumors and assess response\n4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system",[28,29,30,31,32,33,34],"Neoplasms, Solid Tumor","Breast Neoplasms, Triple-Negative","Squamous Cell Carcinoma of Skin","Melanoma","Head and Neck Neoplasms","Carcinoma, Squamous Cell","Carcinoma, Non-Small-Cell Lung",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,31,50,51,15,52,53,54,55,56,57,58,59,60,61,62,63,64,65],"N17350","Intratumoral injection","Intralesional injection","Dose escalation","Dose finding","Dose expansion","Phase 1","Open-label","Safety","Tolerability","Biomarkers","Advanced solid tumors","Triple-negative breast cancer","Cutaneous squamous cell carcinoma","Head and neck squamous cell carcinoma","Non-small cell lung cancer","Onchilles","Onchilles Pharma","ELANE","Phase 2","ELANE pathway","TNBC","cuSCC","HNSCC","SCCHN","metastatic","elastase","therapeutic elastase","neutrophil elastase","New cancer therapy","RECRUITING","2026-07-10",{"date":69,"type":70},"2026-07-13","ACTUAL",{"date":72,"type":70},"2026-05-25",{"date":74,"type":21},"2029-11",{"name":76,"class":77},"Onchilles Pharma Inc","INDUSTRY",6,{"id":80,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":26,"conditions":83,"keywords":84,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":90,"locationsCount":91},"100619019",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34],[36,37,38,39,40,41,42,43,44,45,46,47,48,49,31,50,51,15,52,53,54,55,56,57,58,59,60,61,62,63,64,65],"2026-06-17",{"date":87,"type":70},"2026-06-22",{"date":72,"type":70},{"date":74,"type":21},{"name":76,"class":77},2,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100430983","phase-3-jnj-90301900-nbtxr3-activated-by-radiotherapy-with-or-without-cetuximab-in-la-hnscc-100430983","NCT04892173","JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC","A Phase 3 Study of NBTXR3 Activated by Investigator's Choice of Radiotherapy Alone or Radiotherapy in Combination With Cetuximab for Platinum-based Chemotherapy-Ineligible Elderly Patients With Locally Advanced Head & Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Age greater than or equal to (\\>=) 60 years old\n* Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab\n* Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC\n* One primary tumor lesion amendable for intratumoral injection\n* Ineligible to receive platinum-based chemotherapy with radiation (at least one of the following):\n\n  1. Estimated creatinine clearance \\>= 30 and less than (\\\u003C) 50 milliliters\u002Fminute (mL\u002Fmin) (per Cockcroft-Gault equation),\n  2. Grade \\>= 2 hearing loss or tinnitus,\n  3. Grade \\>= 2 peripheral neuropathy,\n  4. New York Heart Association Class 3\n  5. Aged 70-74 years old with Geriatric 8 (G8) score less than or equal to (\\\u003C=) 14 or Aged \\>= 75 years old\n* Eastern cooperative oncology group (ECOG) performance status 0 to 1\n* Life expectancy \\>= 6 months\n\nExclusion Criteria:\n\n* Carcinoma of the nasopharynx, paranasal sinus, salivary gland, or thyroid gland; or non-squamous histology or SCC of unknown primary origin\n* Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC\n* Loco-regionally recurrent head \\& neck cancer that has been previously treated with surgery, radiation therapy, and\u002For chemotherapy\n* Prior or concurrent primary malignancy (including second synchronous head \\& neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent\n* Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization","60 Years",{"count":101,"type":21},500,[103],"PHASE3","This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 (NBTXR3) \u002F radiation therapy (RT)±cetuximab versus RT±cetuximab in treatment-naïve, platinum-ineligible, elderly participants with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).",[33],[107,108,109,110,111,112,59,113],"LA-HNSCC","NBTXR3","hafnium oxide","radioenhancer","Radiotherapy","RT","radiation therapy","2026-06-04",{"date":116,"type":70},"2026-06-05",{"date":118,"type":70},"2021-12-10",{"date":120,"type":21},"2028-06-30",{"name":122,"class":77},"Johnson & Johnson Enterprise Innovation Inc.",191,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":153},"100314201","phase-1-intralesional-5-fluorouracil-5fu-topical-calcipotriene-treatment-for-scc-100314201","NCT03370406","Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC","Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower Extremities","Inclusion Criteria:\n\n* Biopsy-confirmed SCC more than 1.0 cm and less than 2.0 cm in diameter in the lower extremities, defined as the knees and below.\n* Subjects must have an expected survival of greater than or equal to12 months.\n* Subjects must not be on any other investigational device\u002Fdrug treatment.\n* Subjects must to be willing to adhere to the instructions of the Investigator and his research team and sign an Informed Consent Form prior to entry into the study.\n* Patient is ≥ 18 years of age on day of signing informed consent.\n* Patient must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Female patient of childbearing potential has a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.\n* Female patients enrolled in the study, who are not free from menses for \\> 2 years, post hysterectomy\u002Foophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity throughout the study, starting with the first dose of study drug at visit 1 through 120 days after the last dose of study drug. Approved contraceptive methods include for example: intra-uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception. Male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Patients with any evidence of nodal (Nx) and\u002For metastatic disease including distant subcutaneous and\u002For lymph node metastases.\n* Patients with primary non-cutaneous SCC - such as nasopharyngeal SCC.\n* Patient with history of receiving organ transplantation.\n* Patients with history of iatrogenic systemic immunosuppression.\n* Patients with a history of skin or other disorder(s),that in the opinion of the investigator, requires topical application of steroids and\u002For other creams\u002Fointments.\n* Patients with evidence of active infection - active and\u002For untreated hepatitis B\u002FC, HIV, etc - requiring systemic therapy.\n* Patients with a known history of autoimmune disease.\n* Patients with the following cardiac co-morbidities including:\n\n  * Baseline known prolongation of QT\u002FQTc interval (QTc interval \\>500 msec).\n  * Heart failure either on clinical examination (manifestations include ascites, cardiomegaly, dyspnea, edema, gallop rhythm, hepatomegaly, oliguria, pleural effusion, pulmonary edema, tachycardia) or based on known decreased left ventricular ejection fraction (LV EF) \\\u003C50%.\n  * Patients who have had chemotherapy, radioactive or biological cancer therapy within four weeks prior to the first dose of study drug, or who has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse effects (AEs) due to cancer therapeutics administered more than four weeks earlier. Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the study.\n  * If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Patients currently participating or who have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study drug.\n* Patients expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Patients with a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years.\n\n  ° The time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.\n* Patients who have previously had a severe hypersensitivity reaction to 5-fluorouracil or imiquimod.\n* Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or are not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* Patients who are, at the time of signing informed consent, regularly using illicit drugs or are recently (within the last year) abusing illicit substances (including alcohol).\n* Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.",true,{"count":133,"type":21},30,[24],"This clinical trial proposes to evaluate a relatively unexplored approach to treatment of squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and specifically deliver drug to the tumor. For the proposed phase I clinical trial, the investigators will perform intralesional injections of a well characterized, potent chemotherapeutic agent 5-fluorouracil (5FU) with and without a topical application of 0.005% calcipotriene cream to kill topically accessible SCC cells. The goal of the study is to evaluate the safety profile and tolerability of intralesional-5FU with and without a concomitant topical calcipotriene and measure the clinical objective response rate (ORR) in treated lesions compared to untreated lesions 3 weeks after treatment.",[33],[138,139,140,141,142],"Squamous Cell","Carcinoma","Lower Extremities","5-Fluorouracil","Imiquimod","2026-05-27",{"date":145,"type":70},"2026-06-01",{"date":147,"type":70},"2018-08-03",{"date":149,"type":21},"2027-10-30",{"name":151,"class":152},"Melissa Pugliano-Mauro","OTHER",1,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100405868","prospective-observational-study-to-validate-circulating-hpvdna-and-prognostic-genomic-biomarkers-in-hpv-associated-opscc-100405868","NCT04564989","Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC","LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC","Inclusion Criteria:\n\n* ≥ 18 years of age\n* T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)\n* Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary\n* No prior therapy\n* No evidence of distant metastatic disease\n* p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2\u002F3+) staining intensity\n* Planned for receipt of definitive cancer treatment\n* ECOG Performance Status 0-1\n* Patients must be deemed able to comply with the treatment plan and follow-up schedule.\n* Patients must provide study specific informed consent prior to study entry\n\nExclusion Criteria: All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:\n\n* Prior history of radiation therapy to the head and neck\n* Prior history of head and neck cancer.\n* Inadequate pre-treatment tissue sample for tumor genomic analyses",{"count":162,"type":21},220,"OBSERVATIONAL","The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.",[166,33,167,168],"Oropharyngeal Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma","Oropharynx Squamous Cell Carcinoma",[170,171,172,173,174],"Human Papillomavirus","HPV","p16","Oropharynx","OPSCC","2026-04-27",{"date":177,"type":70},"2026-04-28",{"date":179,"type":70},"2020-11-19",{"date":181,"type":21},"2033-11",{"name":183,"class":152},"UNC Lineberger Comprehensive Cancer Center",3,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":153},"100266135","a-study-on-tumor-budding-guiding-individualized-surgical-planning-of-early-stage-oral-squamous-cell-carcinoma-100266135","NCT02743832","A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.","A Randomized，Multicenter，Prospectie，Controlled Clinical Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.","Inclusion Criteria:\n\n1. Han race;\n2. Oral squamous cell carcinoma is confirmed by pathology;\n3. The section of oral squamous cell carcinoma including primary two-thirds prior to the tongue, buccal mucosa， gingiva， mouth floor， hard palate mucosa;\n4. The primary lesion is no more than 4cm;\n5. Do not find cervical lymph node metastases and distant metastasis in the clinical examination including physical examination and MRI;\n6. Patients and families agree to participate in the study;\n7. Patients do not have cognitive disorders.\n\nExclusion Criteria:\n\n1. Do not meet the inclusion criteria;\n2. The primary lesion is more than 4cm or invade adjacent tissues;\n3. Do not review on schedule;\n4. Patients receive not only surgical procedures, but other antineoplastic treatment;\n5. There are serious adverse events after operation;\n6. Patients quit the study voluntarily;\n7. Patients quit the study because of physical condition.","20 Years","70 Years",{"count":195,"type":21},524,[197],"NA","The purpose of this study is to determine whether cervical lymph node dissection is necessarily performed in the presence of early-stage oral squamous cell carcinoma.",[33],[201,202,203],"Oral squamous cell carcinoma","Tumor budding","Cervical lymph node dissection","2026-04-24",{"date":206,"type":70},"2026-04-30",{"date":208,"type":21},"2026-05-04",{"date":210,"type":21},"2027-06-30",{"name":212,"class":152},"Jinsong Hou",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":153},"100567544","phase-2-lenvatinib-and-pembrolizumab-to-treat-patients-with-anal-or-rectum-cancer-that-has-gotten-worse-after-initial-treatment-100567544","NCT06669572","Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment","A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and\u002For Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.","Inclusion Criteria:\n\n* Histological confirmation of anorectal squamous cell carcinoma per the American Joint Committee on Cancer 8th edition. NOTE: If archived tissue is not available for diagnostic histological confirmation \\[core, incisional, or excisional\\], a new biopsy of a tumor lesion prior to tumor irradiation should be obtained.\n* Unresectable locally advanced or metastatic anorectal squamous cell carcinoma following progression on first line chemotherapy or chemoradiation therapy. Prior use of immunotherapy with Retifanlimab is allowed but not mandatory.\n* Prior chemoradiation therapy with either definitive intent or palliative intent is allowed.\n* Measurable disease based on Response Evaluation Criteria In Solid Tumors 1.1 Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions within 28 days prior to registration.\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti- PDL1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) with the exception of Retifanlimab immunotherapy.\n* Prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agents including events like pneumonitis, myocarditis, renal failure, Guillain Barre syndrome or myasthenia gravis.\n* Active autoimmune disease with ongoing treatment with chronic immunosuppressive therapy such as DMARDs .",{"count":221,"type":21},35,[25],"The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal\u002Frectal cancer that has spread to other parts of the body and will not respond to standard care.",[33,225],"Anorectal Cancer",[227,228,229,230],"chemotherapy","anorectal cancer","Lenvatinib","Pembrolizumab","2026-04-13",{"date":233,"type":70},"2026-04-15",{"date":235,"type":70},"2025-07-11",{"date":237,"type":21},"2029-03-26",{"name":239,"class":152},"University of Chicago",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":153},"100370126","circulating-tumor-dna-ctdna-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100370126","NCT04099290","Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Consent for the use of any residual material from biopsy and\u002For surgical resection (archival tissue) and serial blood draws will be required for enrollment.\n* Age ≥ 18 years of age on day of signing informed consent\n* Newly diagnosed, histologically confirmed squamous cell carcinoma of the head and neck, including the following subtypes: oral cavity, oropharynx, larynx\n* Must be planning to undergo gross total resection of the primary tumor with curative intent at UNC-CH hospital\n* No prior, definitive therapy to primary tumor. Must meet one of the following clinical stages: T3-T4 (if T1\u002FT2 must have nodal involvement), Any N, M0\n* Patient must be amenable to receiving adjuvant therapy with radiotherapy +\u002F- systemic therapy, as clinically indicated, based on either standard of care (SOC) or appropriate clinical trial.\n* Diagnostic tumor material must be available for correlative analysis\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee\n\nExclusion Criteria:\n\n* Has known evidence of metastatic disease based on clinical or radiographic studies\n* Women who are pregnant or nursing\n* History of another primary malignancy in the last 5 years prior to registration. Patients with history of in situ cancer or basal or localized squamous cell skin cancers are eligible.\n* Patients with primary skin cancers of the head and neck, including basal or squamous cell cancers\n* Prior chemotherapy, IP, biologic, or hormonal therapy for HNSCC treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.",{"count":247,"type":21},50,"Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.",[250,33],"Head and Neck Neoplasm",[252,253],"Squamous Cell Carcinoma","Circulating Tumor DNA","2026-02-05",{"date":256,"type":70},"2026-02-06",{"date":258,"type":70},"2020-01-14",{"date":260,"type":21},"2027-02-01",{"name":183,"class":152},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":153},"100586185","phase-1-dose-finding-study-of-zanzalintinib-with-pembrolizumab-and-cetuximab-in-head-and-neck-scc-100586185","NCT06912087","Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC","A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and\u002For Metastatic Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n* Histologically or cytologically confirmed recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC), which is considered incurable by local therapies.\n* Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible.\n* Age: Participants must be at least 18 years old.\n* ECOG Performance Status: Must be 0-1.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.\n* For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing.\n* Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R\u002FM disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy.\n* Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from any adverse events (AEs), including immune-related AEs from prior treatments.\n* Adequate organ and marrow function, including:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n* Platelets ≥ 100,000\u002Fmm3.\n* Hemoglobin ≥ 9 g\u002FdL.\n* Normal liver and kidney function.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Contraception: Sexually active fertile subjects must agree to use a highly effective method of contraception during the study and for 2 months after the last dose of cetuximab and 4 months after the last dose of pembrolizumab.\n\nExclusion Criteria:\n\n* Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors.\n* More than two prior lines of systemic therapy in the recurrent\u002Fmetastatic setting.\n* Relapsed disease within 3 months of definitive therapy.\n* Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment).\n* Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks.\n* Concomitant anticoagulation with oral anticoagulants or platelet inhibitors, unless on stable doses of acceptable anticoagulants.\n* Active infection requiring systemic treatment or significant cardiovascular, gastrointestinal, or other serious health issues that may affect study participation.\n* Known or suspected autoimmune disease, except for specific conditions like type I diabetes or controlled skin disorders.\n* Pregnancy or breastfeeding: Women must not be pregnant or breastfeeding at screening.\n* Other malignancies within the past 2 years (except for certain low-grade cancers like localized skin cancers).",{"count":270,"type":21},36,[24],"This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).",[32,33,274,275,276,277],"Neoplasm Recurrence, Local","Neoplasm Metastasis","Recurrent Squamous Cell Carcinoma","Metastatic Squamous Cell Carcinoma","2025-12-01",{"date":280,"type":70},"2025-12-02",{"date":282,"type":70},"2025-09-29",{"date":284,"type":21},"2027-06-05",{"name":239,"class":152},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":306,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":320},"100395472","phase-1-study-of-safety-and-tolerability-of-bca101-monotherapy-and-in-combination-therapy-in-patients-with-egfr-driven-advanced-solid-tumors-100395472","NCT04429542","Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors","First-in-Human, Phase 1\u002F1b, Open-label, Multicenter Study of Bifunctional EGFR\u002FTGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors","Inclusion Criteria:\n\n* Patient must have measurable disease amendable to biopsy and be willing to undergo both a pre-treatment and on-treatment biopsy, as well as provide archival tumor if available from the primary tumor (a paraffin embedded tumor tissue block sufficient to obtain at least 10 sections of 4 to 5 micrometer thickness).\n* Patient must have a performance status of ≤1 on the Eastern Cooperative Oncology Group Performance Scale.\n* Patients must have evaluable or measurable disease (computed tomography \\[CT\\]\u002Fmagnetic resonance imaging \\[MRI\\] scans performed within 21 days before the screening visit are acceptable) demonstrating measurable disease, i.e., at least 1 unidimensional measurable lesion as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumors (iRECIST).\n* Tumor eligibility:\n\nPART B (Cohort expansion):\n\n1. Single agent BCA101 - patients with the following tumor type will be eligible:\n\n   • Expansion Cohort 1: Cutaneous Squamous Cell Carcinoma (CSCC) - i. patients must have received (or been intolerant to or ineligible for) prior anti-PD-1 therapy in the metastatic or locally advanced setting.\n\n   ii. No prior history of treatment with anti-EGFR antibodies in the unresectable\u002Fmetastatic setting (prior treatment with radiotherapy in the adjuvant setting is allowed).\n2. Combination BCA101 and pembrolizumab - patients with the following tumor types will be eligible:\n\n   • Expansion Cohort 2: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) equal to or greater than 1, as determined by an CLIA-approved laboratory test. Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology).\n\n   i. Patients must have no prior systemic therapy administered in the recurrent or metastatic setting (with the exception of systemic therapy completed \\>6 months prior if given as part of multimodal treatment for locally advanced disease) or prior history of immune checkpoint inhibitors with the exception of neoadjuvant therapy (\\>6 months prior to study drug initiation). No prior history of anti-EGFR antibodies (with the exception of radiosensitizing agents and multimodal treatment for locally advanced disease).\n\n   ii. Patients must provide tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not sufficient): A newly obtained biopsy (within 90 days prior to start of study treatment) is preferred but an archival sample is acceptable.\n\n   iii. Patients must have results from testing of human papillomavirus (HPV) status for oropharyngeal cancer\n   * Expansion Cohort 3: Squamous Carcinoma of the Anal Canal (SCAC), locally advanced\u002Funresectable or metastatic.\n\n     i. Patients must have received (or been intolerant to or ineligible for) at least 1 prior line of chemotherapy and received no more than 2 prior lines of systemic treatments for treatment of unresectable and\u002For metastatic disease. No prior history of immune checkpoint inhibitors.\n   * Expansion Cohort 5: Squamous Non-Small Cell Lung Cancer (SqNSCLC) i. Patients must have a histologically or cytologically confirmed diagnosis of stage IV (AJCC 8th edition) squamous NSCLC. Patients with mixed histology (e.g., adenosquamous) are not allowed.\n\n   ii. Patients must have progressed on one prior systemic therapy in the metastatic setting.\n\n   iii. No prior history of treatment with anti-EGFR antibodies in the metastatic setting.\n\n   • Expansion Cohort 6: Head and Neck Squamous Cell Carcinoma (HNSCC), metastatic or unresectable, recurrent with a Combined Positive Score (CPS) less than 1, as determined by PD-L1 IHC 22C3 pharmDx.\n3. Randomized to either ficerafusp alfa alone or in combination with pembrolizumab • Expansion Cohort 9: Colorectal cancer (CRC) i. Patients must have received at least 2 and no more than 3 prior lines of systemic therapy including two standard treatment regimens.\n\nExclusion Criteria:\n\n* For Part A: Exposure to anti-EGFR antibodies within 4 weeks of the first dose of study drug.\n* Prior treatment with any anti-TGFβ therapy.\n* Prior history of Grade ≥ 2 intolerance or hypersensitivity reaction to cetuximab or other anti-EGFR therapy or other murine proteins or prior discontinuation of therapy in the setting of toxicity related to treatment.\n* Pregnant or breastfeeding women.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose of study drug, with the exception of topical, intranasal, intrabronchial, or ocular steroids.\n* Known history of a hematologic malignancy (or solid tumor other than the ones indicated for this study), unless the patient has undergone potentially curative therapy with no evidence of that disease for 2 years. Does not include tumors with a negligible risk of metastasis or death (e.g. adequately treated basal or squamous cell carcinoma, stage 1 prostate cancer, or carcinoma in situ of the cervix or carcinoma in situ of the breast). Subjects enrolling in the CSCC cohort may have chronic lymphocytic leukemia as long as the patient is not on active treatment.\n* Known cases of human immunodeficiency virus (HIV) are excluded if patients have a CD4+ T-cell (CD4+) count \\\u003C250 cells\u002FuL. To ensure that effective antiretroviral therapy (ART) is tolerated and that toxicities are not confused with investigational drug toxicities, trial participants should be on established ART for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment.\n* Patients with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment\n* Patients with a known history of hepatitis C who have not completed curative antiviral treatment or have a HCV viral load above the limit of quantification",{"count":294,"type":21},292,[24],"The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.",[167,298,299,300,301,302,303,304,32,33,305],"Squamous Cell Carcinoma of Anal Canal","Colorectal Cancer","Squamous Cell Carcinoma of the Lung","EGFR Amplification","Epithelial Ovarian Cancer","Pancreas Cancer","Cutaneous Squamous Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck",[307,308,309,310],"TGFβ","EGFR","pembrolizumab","ficerafusp alfa","2025-08-14",{"date":313,"type":70},"2025-08-15",{"date":315,"type":70},"2020-06-01",{"date":317,"type":21},"2027-06-01",{"name":319,"class":77},"Bicara Therapeutics",20,{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100512705","phase-3-nicotinamide-chemoprevention-for-keratinocyte-carcinoma-in-solid-organ-transplant-recipients---pivotal-trial-100512705","NCT05955924","Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial","Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients: a Multicentre, Pragmatic Randomized Trial","SPRINTR","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Kidney, liver, heart, or lung transplant at least two years ago\n* History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ\n* Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus)\n* Able to attend follow-up visits\n\nExclusion Criteria:\n\n* Use of nicotinamide or niacin (≥250 mg daily) within past 12 weeks\n* Untreated localized skin cancer at baseline (patient can enrol after skin cancer treatment)\n* Biopsy-confirmed acute rejection episode within the past 12 weeks\n* Active liver disease (high AST \\>3 times or bilirubin \\>1.5 times)\n* Severe kidney disease (estimated glomerular filtration rate \\\u003C20 mL\u002Fmin\u002F1.73 m2)\n* Solid organ or hematologic malignancy, invasive melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years\n* Pregnancy or lactation\n* Need for ongoing carbamazepine or primidone\n* Allergy to nicotinamide or any ingredient of the vitamin or placebo capsules",{"count":330,"type":21},396,[103],"As patients live longer after receiving an organ transplant, there is a need to reduce the long-term side effects of the drugs used to prevent organ rejection. In particular, long-term use of these drugs increases the risk of skin cancer. Skin cancer is now a leading cause of illness and disfigurement after kidney, liver, heart, and lung transplantation. Given the increased risk and burden of skin cancer in transplant recipients, prevention is critical.\n\nNicotinamide is a form of Vitamin B3 that has been shown to protect against skin cancer in the general population. However, it is unclear whether nicotinamide is effective among immune-suppressed transplant recipients. Investigators will conduct a clinical trial involving multiple transplant centres in Canada to evaluate whether oral nicotinamide (500 mg twice daily) is effective and safe for preventing skin cancer. Investigators will recruit 396 high-risk adult kidney, liver, heart, and lung transplant patients who have previously had at least one skin cancer. Patients will receive nicotinamide or sham tablets for up to 4 years. The results will inform efforts to improve the long-term health of transplant recipients.",[334,33,335,336],"Non-melanoma Skin Cancer","Carcinoma, Basal Cell","Keratinocyte Carcinoma","2025-02-20",{"date":339,"type":70},"2025-02-21",{"date":341,"type":70},"2023-08-28",{"date":343,"type":21},"2027-08",{"name":345,"class":152},"Women's College Hospital",7,{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":360,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":153},"100399443","tgf--and-pdl-1-inhibition-in-esophageal-squamous-cell-carcinoma-combined-with-chemoradiation-therapy-100399443","NCT04481256","TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY","TAPESTRY","Inclusion Criteria:\n\n* Histologically proven squamous cell carcinoma of the esophagus or gastro esophageal junction.\n* Surgically irresectable (T1-T4a, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS), PET scan and diagnostic CT scan of neck, thorax and abdomen. Patients with M1 disease solely on the basis of supraclavicular metastasis are eligible. Patients with resectable tumors refusing radical surgery are eligible.\n* Locoregional recurrences without distant metastasis after surgery alone or endoscopical resection\n* Locoregional recurrences without distant metastasis after neoadjuvant chemoradiation + resection or definitive chemoradiation outside the previously irradiated area, provided that full dose of radiation can safely be delivered.\n* Tumors that cannot be passed with an endoscope for endoscopic ultrasound are eligible if all other criteria are fulfilled.\n* If the tumor extends below the gastroesophageal (GE) junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction.\n* Age ≥ 18.\n* ECOG performance status 0-2 (cf. Appendix A).\n* Adequate hematological, renal and hepatic functions defined as:\n\n  * Neutrophils ≥ 1.5 x 109\u002FL\n  * Platelets ≥ 100 x 109\u002FL\n  * Hemoglobin ≥ 5.6 mmol\n  * Total bilirubin ≤ 1.5 x upper normal limit\n  * ASAT and ALAT ≤ 1.5 x upper normal limit, Alkaline Phosphatase ≤ 2.5 x upper normal limit.\n  * PT (INR) ≤ 1.5 x upper normal limit and aPTT ≤ 1.5 x upper normal limit.\n  * Creatinine clearance (Cockroft) \\> 60 ml\u002Fmin\n* Written, voluntary informed consent\n* Patients must be accessible to management and follow-up in the treatment center\n\nExclusion Criteria:\n\n* Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.\n* Patient with tracheo-esophageal fistula or extension into the mucosal layer of the trachea, highly at risk to develop fistula. Thus, tumor extension to the trachea is allowed, but not through the trachea.\n* Patients with pathological lymph nodes at both supraclavicular and truncus coeliacus level.\n* Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.\n* Patient (male or female) in the reproductive age is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.\n* Previous chemotherapy, radiation and\u002For treatment with checkpoint inhibitors for the currently present esophageal tumor.\n* Previous chemotherapy and\u002For treatment with targeted agents and\u002For checkpoint inhibitors for other forms of cancer within the last six months.\n* Previous radiation to the mediastinum precluding full dose radiation of the currently present esophageal tumor.\n* Persisting grade \\>1 NCI CTCAE 5.0 toxicity (except alopecia and vitiligo) related to prior therapy; however, grade ≤2 sensory neuropathy is acceptable.\n* Presence of an esophageal stent.\n* History of bleeding diathesis or major bleeding event (grade ≥ 2) in the month prior to first dose of trial treatment.\n* Current use of direct oral anticoagulants or coumarins.\n* Clinically significant cardiovascular disease precluding safe treatment with chemoradiation.\n* Evidence of pulmonary fibrosis and\u002For clinically significant impairment of lung function precluding safe treatment with chemoradiation. In case of doubt about pulmonary function, a lung function test should be performed and, in case of abnormalities, discussed with the principle investigator.\n* Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide or cyclosporine.\n* Mental status that would prohibit the understanding and giving of informed consent.\n* Inadequate caloric- and\u002For fluid intake despite consultation of a dietician and\u002For tube feeding.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine for patients with a history of autoimmune-related hypothyroidism, insulin for patients with type 1 diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo with dermatological manifestations only are eligible to enter the study.\n* A diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg\u002Fday prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Diagnosis of HIV unless stable on antiretroviral therapy for at least 4 weeks, no evidence of multi-drug resistance, viral load of \\\u003C 400 copies\u002Fml and CD4+ T-cells ≥ 350 cells\u002Fµl.\n* Active HBV\u002FHCV. Participants on a stable dose of antiviral therapy with HBV\u002FHCV viral load below the limit of quantification are eligible.\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* An active infection requiring systemic therapy, which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.\n* Administration of a live vaccine within 30 days prior to the first dose of trial treatment. Seasonal flu vaccines that do not contain a live virus are permitted.\n* Patients with prior allogeneic stem cell or solid organ transplantation.",{"count":355,"type":21},49,[197],"The primary objective of this study is to assess the feasibility of treatment with bintrafusp alfa combined with definitive chemoradiation (carboplatin, paclitaxel and radiation) in patients with squamous cell carcinoma of the esophagus or gastroesophageal junction.",[33,359],"Oesophageal Cancer",[361,362,363,364],"Definitive chemoradiation","TGF-beta inhibition","PDL-1 ihibition","feasability","2024-07-25",{"date":367,"type":70},"2024-07-26",{"date":369,"type":70},"2020-11-11",{"date":371,"type":21},"2030-09-01",{"name":373,"class":152},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":153},"100545578","phase-2-neoadjuvant-targeted-therapy-in-patients-with-resectable-egfr-mutated-lung-squamous-cell-carcinoma-100545578","NCT06383728","Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma","Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma: A Single-centre, Single-arm, Phase 2 Trial","GALAXY-02","Inclusion Criteria:\n\n1. Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma;\n2. Gene text confirmed EGFR mutation;\n3. PET-CT confirmed no metastasis;\n4. ECOG physical status score 0-1;\n5. Age ≥ 18 years;\n6. Have one measurable lesion at least;\n7. Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g\u002FL). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be \\\u003C 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN\n8. Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after treatment, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after treatment;\n9. Sign informed consent.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors in the five years before the start of this trial.\n2. Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure \\[higher than II (New York College of Cardiology)\\], severe arrhythmias, liver, kidney or metabolic diseases;\n3. Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;\n4. A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);\n5. Allergic to experimental drugs;\n6. Complicated with HIV infection or active hepatitis.\n7. Vaccination within 4 weeks before the start of this trial;\n8. Those who had undergone other major operations or severe injuries within the previous 2 months;\n9. Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;\n10. Pregnant or lactating women;\n11. Those with neurological diseases or mental disorders;\n12. Participated in another therapeutic clinical study at the same time;\n13. Other researchers did not consider it appropriate to enroll in the group.","75 Years",{"count":384,"type":21},51,[25],"Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.",[388,33],"Lung Cancer",[390,391,392],"neoadjuvant targeted therapy","EGFR-mutated lung squamous cell carcinoma","surgery","2024-05-07",{"date":395,"type":70},"2024-05-09",{"date":397,"type":70},"2024-04-01",{"date":399,"type":21},"2029-04-30",{"name":401,"class":152},"The First Affiliated Hospital of Guangzhou Medical University",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":382,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":153},"100231401","phase-2-cyclin-d1-based-tpf-induction-chemotherapy-for-oral-squamous-cell-carcinoma-patients-at-clinical-n2-stage-100231401","NCT02290145","Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage","Cyclin D1 Based TPF(Docetaxel, Cisplatin and 5-fluorouracil) Induction Chemotherapy for OSCC(Oral Squamous Cell Carcinoma) Patients at cN2(Clinical Node 2) Stage: a Phase II Randomized Controlled Trial","Inclusion Criteria:\n\n* Age: 18 to 75 years old.\n* Sex: both males and females.\n* Karnofsky performance status (KPS) \\>60.\n* Histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).\n* Cyclin D1 high expression\n* Clinical stage III\u002FIVA (T1-2, N2, M0 or T3-4, N2, M0, UICC\\[International Union Against Cancer\\] 2002) with resectable lesions.\n* Adequate hematologic function: white blood cell \\>3,000\u002Fmm3, hemoglobin\\>8g\u002FL, platelet count\\>80,000\u002Fmm3.\n* Hepatic function: ALAT(alanine aminotransferase)\u002FASAT(aspartate transaminase) \\\u003C2.5 times the upper limit of normal (ULN), bilirubin \\\u003C1.5 times ULN.\n* Renal function: serum creatinine \\\u003C1.5 times ULN.\n* Written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease and other cancers.\n* Surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).\n* Previous radiotherapy or chemotherapy.\n* Other previous malignancies within 5 years.\n* Can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.\n* Legal incapacity or limited legal capacity.\n* Creatinine clearance \\\u003C30ml\u002Fmin.\n* Pregnancy (confirmed by serum or urine β-HCG) or lactation period.",{"count":410,"type":21},48,[25],"The purpose of this study is to To confirm the predictive value of CCND1 for TPF induction in cN2 patients with OSCC",[414,33],"Mouth Neoplasms",[416],"docetaxel, cisplatin, 5-FU, cyclinD1","2023-11-21",{"date":419,"type":70},"2023-11-22",{"date":421,"type":4},"2016-12",{"date":423,"type":21},"2026-12",{"name":425,"class":152},"Shanghai Jiao Tong University School of Medicine",{"id":427,"slug":428,"hasResults":11,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":153},"100458627","phase-2-anlotinib-hydrochloride-capsules-combined-with-tqb2450-injection-in-esophageal-squamous-cell-carcinoma-patients-100458627","NCT05252078","Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients","An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy","ALTER-E005","Inclusion Criteria:\n\n* Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.\n* ≥ 18 years old.\n* ECOG performance status of 0-1\n* Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.\n* Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.\n* Laboratory tests must be met:\n* Neutrophils count =\u002F\\> 1.5 x 109\u002FL, platelets count =\u002F\\> 75 x 109\u002FL, Hb =\u002F\\> 90 g\u002FL, WBC =\u002F\\> 3 x 109\u002FL.\n* total bilirubin =\u002F\\\u003C 1.5 x ULN, ALT and AST =\u002F\\\u003C 2.5 x ULN.\n* Creatinine =\u002F\\\u003C 1.5 x ULN.\n* APTT, INR, PT =\u002F\\\u003C 1.5 x ULN.\n* TSH =\u002F\\\u003C ULN.\n* Myocardial enzymes in the normal range.\n* LVEF =\u002F\\> 50%.\n\nExclusion Criteria:\n\n* Patients received other antitumor adjuvant therapy after surgical resection.\n* Concurrent malignancy (except cured basal cell carcinoma of the skin).\n* Patients was diagnosed cervical esophageal carcinoma.\n* Patients who have received prior targeted therapy (anti-VEGF\u002FVEGFR) or immunity therapy (anti-PD-1\u002FPD-L1\u002FCTLA-4).\n* Patients who are allergic to other monoclonal antibodies.\n* Patients with a history of immunodeficiency (or active autoimmue disease), or other acquired congenital immunodeficiency diseases.\n* Immunosuppressant, systemic, or absorbable local hormone therapy (\\> 10mg\u002F day of prednisone or other equivalent hormone) is required for immunosuppression and continued within 2 weeks of initial administration.\n* Patients with multiple factors affecting oral administration.\n* Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage.\n* With bleeding tendency. Patients with any bleeding or bleeding event CTC AE grade 3 in the 4 weeks prior to initial administration. The presence of digestive diseases or active bleeding of unresected tumors, or other conditions that the investigator determined which could lead to gastrointestinal bleeding or perforation.\n* Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.\n* Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg).\n* Patients with myocardial infarction, myocardial ischemia, arrhythmias with poor control (including QTC interval male \\> 450 ms, female\\> 470 ms) and cardiac insufficiency of grade II according to NYHA standard.\n* Active or uncontrolled severe infection (≥ CTC AE Grade 2 infection).\n* HIV test positive.\n* Proteinuria =\u002F\\>2+ and confirmed 24-hour urinary protein quantification \\> 1.0 g.\n* Vaccination with prophylactic or attenuated vaccine within 4 weeks prior to initial administration.\n* According to the investigators' judgment, there are factors that endanger patient or prevent patients from completing the study.",{"count":133,"type":21},[25],"This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).",[438,439,440,441,442,443,444,445,446,447,33],"Esophageal Squamous Cell Carcinoma","Esophageal Neoplasms","Esophageal Diseases","Gastrointestinal Neoplasms","Gastrointestinal Diseases","Digestive System Neoplasms","Digestive System Diseases","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms, Squamous Cell","2022-12-14",{"date":450,"type":70},"2022-12-16",{"date":452,"type":70},"2022-06-02",{"date":454,"type":21},"2026-11",{"name":456,"class":152},"Jiangxi Provincial Cancer Hospital"]