[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-esophageal-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-esophageal-squamous-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,70,117,139,162,188,209,230,254],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473",false,"NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients 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 enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Advanced Esophageal Squamous Cell Carcinoma","Advanced Renal Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Gastroesophageal Junction Adenocarcinoma","Hepatocellular Carcinoma","Locally Advanced Urothelial Carcinoma","Lung Non-Small Cell Carcinoma","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Urothelial Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Renal Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Urothelial Carcinoma","Unresectable Urothelial Carcinoma","RECRUITING","2026-06-05",{"date":60,"type":61},"2026-06-09","ACTUAL",{"date":63,"type":61},"2024-04-30",{"date":65,"type":20},"2026-12-31",{"name":67,"class":68},"Mayo Clinic","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100509238","phase-1-a-phase-ibii-study-of-an-anti-her3-antibody-hmbd-001-with-cetuximab---docetaxel-in-advanced-squamous-cell-cancers-100509238","NCT05910827","A Phase Ib\u002FII Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +\u002F- Docetaxel in Advanced Squamous Cell Cancers","A Phase Ib\u002FII Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas","Inclusion Criteria:\n\n* Ability to understand and be willing to sign an informed consent form\n\n  * Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is \\> 18 years of age)\n  * Eastern Cooperative Oncology Group (ECOG) status of 0 to 1\n  * Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable\n  * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,\n  * Have an estimated life expectancy of at least 3 months\n  * Participants must be willing to provide a fresh tumor biopsy sample\n  * Have adequate organ function\n  * Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal\n  * Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion\n\nExclusion Criteria:\n\n* Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C\n\n  * Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and\u002For KRAS G12C mutation\n  * Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \\>2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and\u002For impact the study results e.g., alopecia\n  * Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment\n  * Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline\n  * Evidence of abnormal cardiac function\n  * History of uncontrolled allergic reactions and\u002For known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into\n  * Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n  * Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment\n  * Known Human Immunodeficiency Virus (HIV) infection\n  * Active hepatitis B or hepatitis C infection\n  * Pregnant or breast feeding\n  * COVID 19 infection within 3 months prior to the first dose of the study drug\n  * COVID 19 vaccination within 14 days prior to the first dose of the study drug\n  * Treatment with strong inhibitors or inducers of CYP3A4",{"count":78,"type":20},398,[80,23],"PHASE1","This is a Phase Ib\u002FII multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers",[83,84,26,85,86,87,88],"Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Advanced Head and Neck Squamous Cell Carcinoma","Cervical Squamous Cell Carcinoma","Advanced Cutaneous Squamous Cell Carcinoma","Nasopharyngeal Cancinoma (NPC)","Squamous Cell Carcinoma",[90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"NSCLC","Non-small Cell Lung Cancer","sqNSCLC","Lung","Squamous","HER3","ErbB3","Docetaxel","Cetuximab","cervical squamous cell carcinoma","HNSCC","CSCC","ESCC","advanced squamous cell cancer","NPC","SCC","2026-05-24",{"date":108,"type":61},"2026-05-27",{"date":110,"type":61},"2024-02-05",{"date":112,"type":20},"2027-12",{"name":114,"class":115},"Hummingbird Bioscience","INDUSTRY",20,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":69},"100630211","phase-2-a-study-evaluating-the-safety-and-efficacy-of-js212-combination-therapy-in-patients-with-advanced-esophageal-squamous-cell-carcinoma-100630211","NCT07484724","A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma","An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (ESCC)","Inclusion Criteria:\n\n1. Male or female subjects aged 18 to 75 years (inclusive) at the time of signing the Informed Consent Form (ICF).\n2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) that is locally advanced, recurrent, or metastatic, and not amenable to radical treatment.\n3. No prior systemic anti-tumor therapy. For patients who received neoadjuvant\u002Fadjuvant therapy or radical concurrent chemoradiotherapy, the interval from the last dose of chemotherapy to disease recurrence or progression must be \\> 6 months to be eligible for screening.\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Expected survival ≥ 12 weeks\n\nExclusion Criteria:\n\n1. Prior treatment with any of the following: anti-PD-1 or anti-PD-L1 antibody therapy; ADC therapy targeting EGFR and\u002For HER3, or ADC therapy with a topoisomerase I inhibitor as the toxic payload;\n2. Subjects at high risk of bleeding or esophageal fistula, e.g., lesions with large ulcers or direct invasion of vital adjacent organs such as the aorta or trachea;\n3. Subjects with a history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose;\n4. Presence of active central nervous system (CNS) metastases;\n5. Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose;\n6. Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion\u002Fexclusion criteria;\n7. Severe cardiovascular or cerebrovascular disease;\n8. Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；","75 Years",{"count":126,"type":20},280,[23],"This study is an open-label, multi-center phase II clinical trial aimed to evaluat the safety and preliminary efficacy of JS212 combination therapy in patients with advanced esophageal squamous cell carcinoma (ESCC).",[26],"2026-04-21",{"date":132,"type":61},"2026-04-22",{"date":134,"type":61},"2026-04-13",{"date":136,"type":20},"2028-04-01",{"name":138,"class":68},"Shanghai Junshi Bioscience Co., Ltd.",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":69},"100630455","phase-3-a-study-of-yl201-versus-investigators-choice-of-chemotherapy-in-participants-with-locally-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-after-failure-of-first-line-therapy-100630455","NCT07487896","A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy","A Randomized, Controlled, Multicenter Phase III Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy (TAISHAN-303)","Inclusion Criteria:\n\n1. Age: ≥18 years;\n2. Voluntary participation in this study with signed informed consent and good compliance.\n3. ECOG PS score: 0-1;\n4. estimated life expectancy \\>3 months;\n5. Histologically or cytologically confirmed ESCC with unresectable locally advanced or metastatic disease\n6. Previously received one line of systemic standard therapy for unresectable locally advanced or metastatic ESCC and experienced disease progression\n7. Adequate organ function.\n8. At least one measurable lesion\n9. Willing to provide biopsy or archived tumor tissue.\n\nExclusion Criteria:\n\n1. Other malignancies within 5 years prior to first dose or currently concurrent malignancies.\n2. Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except for alopecia (any grade), hyperpigmentation (any grade), peripheral neuropathy (≤ Grade 2), and lymphopenia (≤ Grade 3).\n3. Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment\n4. Any arterial thromboembolic event within 6 months prior to randomization, or venous thromboembolic events of Grade ≥ 3 according to NCI CTCAE version 5.0.\n5. Known active tuberculosis (TB). Participants suspected of having active TB must undergo clinical evaluation to rule it out.\n6. History of immunodeficiency or positive test for human immunodeficiency virus (HIV) antibodies. Participants with known active syphilis infection are also excluded.\n7. Current active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).\n8. Known allergy to any component of the investigational product; history of severe allergic reactions (e.g., anaphylactic shock); or known history of severe hypersensitivity reactions to other monoclonal antibodies or recombinant proteins, or previous severe infusion reactions.\n9. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period.\n10. Any disease, medical condition, organ dysfunction, or social\u002Fpsychological circumstance that, in the investigator's judgment, may interfere with the participant's ability to sign the informed consent form (ICF), compromise cooperation or compliance with study procedures, or affect the interpretation of study results. This includes, but is not limited to, psychiatric disorders, substance\u002Falcohol abuse, or a history of drug abuse.",{"count":147,"type":20},440,[149],"PHASE3","This is a large clinical study carried out at multiple hospitals. Participants will be randomly assigned to one of two groups: one group will receive a new medicine called YL201, and the other group will receive standard chemotherapy chosen by the doctor.\n\nThe purpose of the study is to see whether YL201 works better and is safer for people with locally advanced or metastatic esophageal squamous cell carcinoma whose first-line treatment has stopped working.\n\nThe study will also look at how YL201 is processed in the body (Pharmacokinetics), whether it triggers any immune reactions, and whether certain biological markers can help predict how well it works.",[26],"NOT_YET_RECRUITING","2026-03-24",{"date":155,"type":61},"2026-03-30",{"date":157,"type":20},"2026-04-30",{"date":159,"type":20},"2028-12-31",{"name":161,"class":115},"MediLink Therapeutics (Suzhou) Co., Ltd.",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100629022","phase-2-study-of-mri-guided-personal-chemoradiotherapy-and-immunotherapy-for-limited-advanced-esophageal-squamous-caicinoma-100629022","NCT07469241","Study of MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma.","MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma: A Prospective, Multicenter, Single Arm, Phase II Study (FUTURE-3)","FUTURE-3","Inclusion Criteria:\n\n* Obtain written informed consent before any trial-related procedures are implemented;\n* Age 18-80 years;\n* ECOG performance status score: 0-2 points;\n* Pathologically confirmed esophageal squamous cell carcinoma;\n* Locally advanced stage, unresectable or refusing surgery, and stage IV with only extra-regional lymph node metastasis;\n* Tolerance of contrast-enhanced MRI;\n* Expected survival \\> 3 months;\n* Adequate organ function; subjects must meet the following laboratory criteria:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹\u002FL;\n  * Platelet count ≥ 100 × 10⁹\u002FL.\n  * Hemoglobin \\> 9 g\u002FdL;\n  * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN);\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;\n  * Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 ml\u002Fmin;\n  * Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN;\n  * Normal thyroid function, defined as TSH within the normal range. If baseline TSH is outside the normal range, subjects with normal total T3 (or FT3) and FT4 may also be enrolled;\n  * Cardiac enzyme levels are within the normal range (simple laboratory abnormalities deemed clinically insignificant by the investigator may also be enrolled);\n* For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to the first administration of the study drug (day 1 of cycle 1), and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-reproductive-age women are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;\n* If there is a risk of pregnancy, all subjects (regardless of gender) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).\n\nExclusion Criteria:\n\n* Enhanced MRI showing a primary esophageal lesion thickness less than 5 mm and a short diameter lymph node less than 1 cm.\n* Severe emphysema, interstitial lung disease, or COPD.\n* History of other malignant tumors and chemotherapy within the past 2 years.\n* History of chest radiotherapy.\n* An active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n* Currently receiving systemic glucocorticoid therapy (excluding nasal sprays, inhaled or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose.\n\nNote: Physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) are permitted.\n\n* Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n* Known adverse reactions to the study drug. 9) Individuals allergic to the drug or excipients;\n* Individuals with a known history of human immunodeficiency virus (HIV) infection (i.e., HIV1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive with a detected HBV-DNA copy number greater than the upper limit of normal values in the laboratory of their research center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled:\n\n  * HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) before the first dose. Subjects should receive anti-HBV therapy throughout the study chemotherapy treatment to avoid viral reactivation.\n  * For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary.\n* Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit);\n* Subjects who received a live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated influenza vaccines for seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal live attenuated influenza vaccines are not permitted.\n* Pregnant or lactating women;\n* Presence of any serious or uncontrollable systemic disease, such as:\n\n  * Significant and symptomatic abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;\n  * Unstable angina, congestive heart failure, or chronic heart failure with a New York Heart Association (NYHA) classification ≥2;\n  * Any arterial thrombosis, embolism, or ischemia that has occurred within 6 months prior to enrollment in treatment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;\n  * Poorly controlled blood pressure (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>140 mmHg).\n  * History of non-infectious pneumonia requiring glucocorticoid therapy within one year prior to the first dose, or current clinically active interstitial lung disease;\n  * Active pulmonary tuberculosis;\n  * Active or uncontrolled infection requiring systemic treatment;\n  * Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;\n  * Liver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis;\n  * Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n  * Urinalysis showing ≥++ proteinuria, and 24-hour urine protein quantification \\> 1.0 g;\n  * Patients with mental disorders who cannot cooperate with treatment;\n* Medical history or disease evidence, treatment or abnormal laboratory test values that may interfere with trial results or prevent full participation of subjects in the study, or other circumstances deemed unsuitable for enrollment by the investigator.","80 Years",{"count":19,"type":20},[23],"FUTURE-3 was a prospective, multicenter, single-arm phase II study designed to explore the efficacy and safety of MRI-guided individualized chemoradiotherapy for locally advanced esophageal squamous cell carcinoma. The primary endpoint was one-year progression-free survival rate.",[26,54],[176,177,178,179],"Limited Advanced Esophageal Squamous Caicinoma","MRI-guided","Chemoradiotherapy","adebrelimab","2026-03-10",{"date":182,"type":61},"2026-03-13",{"date":180,"type":20},{"date":185,"type":20},"2029-06-30",{"name":187,"class":68},"Fudan University",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":69},"100627261","phase-3-a-phase-iii-study-of-first-line-anlotinib-combined-with-benmelstobart-in-patients-with-advanced-esophageal-squamous-cell-carcinoma-100627261","NCT07446335","A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma","A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined With Benmelstobart Versus Toripalimab Combined With Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations","Inclusion Criteria:\n\n* (1) Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (excluding adenosquamous carcinoma); (2) No prior systemic therapy, or recurrence more than 6 months after completion of (neo)adjuvant therapy or definitive chemoradiotherapy; (3) Age: ≥18 years (calculated from the date of informed consent signature); ECOG PS score: 0-1; estimated life expectancy \\>3 months; (4) Presence of TP53 mutation or FAT1 mutation, and absence of NOTCH3 mutation; (5) At least one measurable lesion as confirmed by RECIST 1.1 criteria; measurable lesions should not have received prior local treatment such as radiotherapy (lesions within prior radiation fields may be selected as target lesions if progression is confirmed); (6) Adequate major organ function meeting the following criteria:\n* Hemoglobin ≥90 g\u002FL;\n* Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL;\n* Platelets ≥75 × 10\\^9\u002FL;\n* Total bilirubin ≤1.5 × upper limit of normal (ULN);\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if liver metastases present);\n* Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin;\n* Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤1.5 × ULN (for patients not receiving anticoagulation);\n* Thyroid-stimulating hormone (TSH) ≤ULN (if TSH abnormal, normal free T3 and free T4 are acceptable); (7) Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with negative serum or urine pregnancy test within 7 days prior to enrollment; men must agree to use effective contraception during the study and for 6 months after study completion, see Section 5.4 for details; (8) Voluntary participation in this study with signed informed consent and good compliance.\n\nExclusion Criteria:\n\n* (1) Other malignancies within 3 years prior to first dose or currently concurrent malignancies, except:Other malignancies treated with surgery alone with continuous disease-free survival (DFS) of ≥5 years;Cured cervical carcinoma in situ, non-melanomatous skin cancer, and superficial bladder tumors \\[Ta (non-invasive), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)\\]; (2) Conditions affecting intravenous injection or blood collection, or factors affecting oral drug administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction); (3) Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except Grade 2 alopecia, Grade 2 peripheral neuropathy, Grade 2 anemia, clinically non-significant and asymptomatic laboratory abnormalities, and hypothyroidism stable on hormone replacement therapy judged by investigator as having no safety risk; (4) Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment (except protocol-required surgery), or presence of non-healing wounds or fractures. \\[Major surgery defined as Grade 3 or higher per National Surgical Classification Directory 2022\\]; (5) Esophageal squamous cell carcinoma with active bleeding from primary lesion within 2 months; hematemesis or melena with daily blood loss ≥2.5 mL within 3 months prior to screening, or any bleeding event ≥CTCAE Grade 3, or any bleeding signs or history regardless of severity judged by investigator as unsuitable for enrollment; (6) Arterial or venous thrombotic events within 6 months prior to first dose, including cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism; (7) Active viral hepatitis with inadequate control. Eligible if: HBsAg-positive subjects: HBV DNA \\\u003C2000 IU\u002FmL (or 1×10⁴ copies\u002FmL) or receiving anti-HBV treatment for ≥1 week prior to study with ≥1 log reduction in viral load, with willingness to continue anti-HBV therapy throughout study; HCV-infected subjects (HCV Ab or HCV RNA positive): judged by investigator as stable or receiving approved antiviral treatment at enrollment with plan to continue; (8) Active syphilis infection requiring treatment; (9) Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis requiring treatment, or symptomatic active pneumonia; (10) History of psychoactive substance abuse with inability to abstain, or psychiatric disorder; (11) Prior or planned allogeneic bone marrow or solid organ transplantation; (12) History of hepatic encephalopathy; (13) Significant cardiovascular disease, including any of the following:\n\n  1. New York Heart Association (NYHA) Class II or greater heart failure or left ventricular ejection fraction (LVEF) \\\u003C50% by echocardiography;\n  2. History of clinically significant ventricular arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmia requiring continuous antiarrhythmic medication;\n  3. Unstable angina pectoris;\n  4. Myocardial infarction within 12 months;\n  5. Fridericia-corrected QT interval (QTcF) \\>450 msec for males or \\>470 msec for females (if abnormal, three consecutive measurements ≥2 minutes apart, use average);\n  6. Congenital long QT syndrome or family history;\n  7. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to randomization (implanted port or catheter-related thrombosis, or superficial venous thrombosis not considered \"serious\");\n  8. Current use or recent use (within 7 days prior to study treatment) of aspirin (\\>325 mg\u002Fday), dipyridamole, ticlopidine, clopidogrel, or cilostazol; (14) Active or uncontrolled severe infection (≥CTCAE Grade 2); (15) Renal failure requiring hemodialysis or peritoneal dialysis; (16) History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disorders; (17) Use of immunosuppressants or systemic or absorbable topical corticosteroids for immunosuppressive purposes within 7 days prior to first dose (except prednisone ≤10 mg daily or equivalent); (18) Epilepsy requiring treatment; (19) Tumor-related symptoms and treatment:\n\n  \u003C!-- -->\n\n  1. Cytotoxic chemotherapy, immunotherapy within 3 weeks, or radiotherapy or small molecule targeted therapy within 2 weeks prior to first dose, or within 5 half-lives of drug (whichever is shorter) from last treatment; (prior radiotherapy: target lesions should not be within radiation field, or if within field, progression must be confirmed);\n  2. Traditional Chinese medicines with anti-tumor indications approved by NMPA within 2 weeks prior to first dose (including Compound Cantharis Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Brucea Javanica Oil Injection\u002FCapsules, Xiaoaiping Tablets\u002FInjection, Huachansu Capsules, etc.);\n  3. Imaging evidence of significant tumor invasion into adjacent organs (aorta or trachea) with increased risk of bleeding or fistula; ulcerative ESCC with increased bleeding risk due to proximity to vessels;\n  4. Known complete esophageal obstruction requiring interventional relief;\n  5. Post-esophageal or tracheal stent placement;\n  6. Uncontrolled pleural effusion, pericardial effusion, or moderate to severe ascites requiring repeated drainage (investigator judgment);\n  7. Known spinal cord compression, carcinomatous meningitis, or brain metastasis with symptoms or symptom control \\\u003C4 weeks; (20) Known hypersensitivity to study drug excipients; (21) Prior treatment with anlotinib hydrochloride or other anti-angiogenic agents, or any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody; (22) Participation in other interventional clinical trials with investigational drug use within 4 weeks prior to first dose; (23) Pregnancy, lactation, or planned pregnancy during study period; (24) Any condition that, in the opinion of the investigator, would pose significant safety risk to the subject or interfere with completion of the study.",{"count":196,"type":20},578,[149],"A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined with Benmelstobart versus Toripalimab Combined with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations",[26],"2026-02-26",{"date":202,"type":61},"2026-03-03",{"date":204,"type":20},"2026-04",{"date":206,"type":20},"2029-06",{"name":208,"class":68},"The First Affiliated Hospital of Zhengzhou University",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":124,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":69},"100553677","phase-2-ak112-combined-with-chemotherapy-as-the-first-line-treatment-in-advanced-esophageal-squamous-cell-carcinoma-patients-100553677","NCT06489197","AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients","Ivonescimab(AK112) Combined With Chemotherapy as the First-line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma (ESCC): A Single Arm , Phase II Trial","Inclusion Criteria:\n\n1. Signed the informed consent；\n2. Male or female patients ≥18 and ≤ 75 years old;\n3. ECOG physical status score is 0 or 1;\n4. Patients with non resectable or metastatic advanced ESCC confirmed by pathological ocytological examination;\n5. No previous systemic treatment;\n6. Expected survival time ≥ 3 months;\n7. Patients must have at least one measurable metastatic lesion according to RECIST version 1.1;\n8. Normal organ function:\n\n   1. Hematology :Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (1500\u002Fmm3); Platelet count ≥ 100 × 109\u002FL (100000\u002Fmm3); Hemoglobin ≥ 90g\u002FL;\n   2. Kidney:The calculated value of creatinine clearance rate (CrCl) is ≥ 50 mL\u002Fmin;Normal urine routine, urine protein\\\u003C2+or 24-hour (h) urine protein quantification\\\u003C1.0 g;\n   3. Liver:Total serum bilirubin (TBiL) ≤ 1.5 × ULN;AST and ALT ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT can be ≤ 5 × ULN;Serum albumin (ALB) ≥ 30g\u002FL;\n   4. Normal coagulation function, international standardized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;\n9. Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug; For males, surgical sterilization or agreement to use appropriate methods of contraception during observation and within 8 weeks after the last administration of study medication should be considered;\n10. Comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study;\n\nExclusion Criteria:\n\n1. Local advanced esophageal squamous cell carcinoma that can be curative through surgery or potentially cured through radiation therapy;\n2. Suffering from other malignant tumors within the 5 years prior to enrollment. Patients with other malignant tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ, are not excluded;\n3. Active bleeding signs of the lesion are displayed under endoscopy;\n4. Currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration;\n5. Receiving immunotherapy in the past, including immune checkpoint inhibitors (such as anti-PD-1\u002FL1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any other treatment targeting the immune mechanism of tumors;\n6. Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration;\n7. Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, glucocorticoids, or immunosuppressants) have occurred within 2 years prior to the first administration.\n8. The study is currently undergoing systemic glucocorticoid therapy (excluding local glucocorticoids through nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first administration; Note: Physiological doses of glucocorticoids (≤ 10 mg\u002Fday of prednisone or equivalent) are allowed to be used;\n9. Clinically significant gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess, fistula formation, etc. occur within 6 months before the first administration;\n10. Active, uncontrolled, or recurrent inflammatory gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, radiation enteritis, hemorrhagic enteritis, chronic diarrhea, etc.);\n11. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure (classified as grade 2 or above according to the New York Heart Association functional classification) or vascular disease (such as aortic aneurysm with a risk of rupture) that requires hospitalization within 12 months prior to the first administration, or other cardiac damage that may affect the safety evaluation of the investigational drug (such as poorly controlled arrhythmias, myocardial ischemia);\n12. Any arterial thromboembolism events, NCI CTCAE 5.0 grade 3 or above venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to the first administration; Currently, there is hypertension and after treatment with oral antihypertensive drugs, the systolic blood pressure is ≥ 160mmHg or the diastolic blood pressure is ≥ 100mmHg;\n13. Severe infections occurring within 4 weeks prior to the first administration, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti infective treatment within 2 weeks prior to the first administration (excluding antiviral treatment for hepatitis B or C);\n14. Subjects with active hepatitis B are required to receive anti hepatitis B virus treatment during the study treatment; Active hepatitis C subjects (HCV antibody positive and HCV RNA levels above the detection limit);\n15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n16. If the toxicity of previous anti-tumor treatments has not improved, it is defined as the toxicity has not returned to level 0 or 1 of NCI CTCAE 5.0, or the level specified in the inclusion\u002Fexclusion criteria, except for hair loss;\n17. Known to be allergic to any component of any investigational drug; Known medical history of severe hypersensitivity reactions to other monoclonal antibodies;\n18. If a live vaccine or attenuated live vaccine is administered within 30 days prior to the first administration, or if a live vaccine or attenuated live vaccine is planned to be administered during the study period, the use of inactivated vaccines is allowed;\n19. Known history of mental illness, drug abuse, alcohol or drug abuse;\n20. Pregnant or lactating women;\n21. Those who have undergone major surgical procedures or experienced severe trauma within 30 days prior to the first administration, or those who have planned major surgical procedures within 30 days after the first administration (as determined by the investigator); Minor local surgeries were performed within 3 days prior to the first administration (excluding peripheral venous puncture, central venous catheterization, and intravenous infusion port implantation);\n22. During the screening period, imaging showed significant necrosis and cavities in the tumor, and the researchers determined that entering the study would pose a risk of bleeding; Tumors invade important blood vessels and organs; Tumor mediastinal lymph node metastasis invading the trachea, main bronchus, or at risk of developing esophagotracheal fistula or esophagopleural fistula;\n23. Have a history of severe bleeding tendency or coagulation dysfunction; There are significant clinically significant bleeding symptoms within one month prior to the first administration; Patients who have previously or currently require long-term therapeutic anticoagulation therapy (such as atrial fibrillation patients who meet CHADS2 score ≥ 2);\n24. The researcher believes that there are other potential risks that are not suitable for participation in this study;",{"count":217,"type":20},30,[23],"This is a single arm，phase 2 study evaluating the safety and efficacy of Ivonescimab(AK112) combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma (ESCC). In this study, patients with advanced esophageal squamous cell carcinoma who had not received any systematic treatment in the past will be enrolled.\n\nThe research will be conducted in two stages. In the first part, 6 patients were enrolled in the group. After the last subject in the group completed at least 21 days of observation after the first medication, the researchers will conduct a preliminary safety and effectiveness assessment. If the safety and tolerability are good, it will enter the second expansion part till the study enrolled 30 patients. Patients who met the inclusion criteria were treated with AK112 (20mg\u002Fkg, intravenous infusion, d1, Q3W) in combination with albumin paclitaxel (220mg\u002Fm2, intravenous infusion, d1, Q3W) and cisplatin (75mg\u002Fm2, intravenous infusion, d1, Q3W), of which the maximum treatment time of chemotherapy was up to six cycles, and the maximum treatment time of AK112 was 24 months. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.",[102,26],"2025-01-20",{"date":223,"type":61},"2025-01-22",{"date":225,"type":61},"2024-11-16",{"date":227,"type":20},"2027-08-30",{"name":229,"class":68},"Tianjin Medical University Cancer Institute and Hospital",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":124,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":69},"100455719","phase-2-penpulimab-plus-chemotherapy-withwithout-anlotinib-for-patients-with-advanced-esophageal-squamous-cell-carcinoma-100455719","NCT05214222","Penpulimab Plus Chemotherapy With\u002FWithout Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma","Penpulimab Plus Chemotherapy With or Without Anlotinib as First-line Therapy for Patients With Advanced Esophageal Squamous Cell Carcinoma (Answer): A Randomized Two-arm Clinical Study","ANSWER","Inclusion Criteria:\n\n1. Patients with stage III-IV esophageal squamous cell carcinoma who are not candidates for curative treatment (excluding adenosquamous carcinoma mixed type);\n2. Those who have not received systemic treatment in the past, or (new) adjuvant treatment\u002Fradical surgery\u002Fradical radiotherapy and chemotherapy have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after radiotherapy alone. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time\\> 2 weeks;\n3. According to the RECIST 1.1 version of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion; the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area, if it is confirmed that it has progressed, and meets RECIST1.1 Standard, target lesions can also be selected);\n4. Patients between 18 and 75 years old;\n5. ECOGPS score: 0\\~1 points; the expected survival period is more than 3 months;\n6. Tumor specimens can be provided to determine gene detection and PD-L1 expression, at least 15 white sheets (assessed by the company); provide two oral swabs; within 7 days before the medication, the first, third, and sixth at the end of the cycle, one tube of 6ml EDTA anticoagulant blood will be provided.\n7. It has sufficient organ and bone marrow function, that is, it meets the following standards:\n\n(1) The standard of routine blood examination must meet: Hemoglobin content (HB) ≥90g\u002FL (no blood transfusion within 28 days); Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥100×10\\^9\u002FL. (2) The biochemical inspection shall meet the following standards: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5´ULN; if there is liver metastasis, ALT and AST≤5´ULN; Cr≤1.5´ULN or creatinine clearance (CCr)≥60ml\u002Fmin; (Cockcroft-Gault formula) (3) The coagulation function is adequate, which is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8) Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the treatment, and they must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:\n\n1. Post-menopausal is defined as amenorrhea at least 12 months after the age is greater than 50 years and all exogenous hormone replacement therapy is stopped;\n2. For women younger than 50 years old, if the amenorrhea is 12 months or more after stopping all exogenous hormone treatments, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference value range, also Can be considered post-menopausal;\n3. Have received irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral fallopian tube resection, except for bilateral tubal ligation.\n\nFor men, they must agree to use appropriate methods of contraception or have been surgically sterilized during the trial period and 8 weeks after the last trial drug administration; 9) The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. It is known that esophageal squamous cell carcinoma tends to be completely obstructed under endoscopy and requires interventional treatment to relieve the obstruction;\n2. Patients with ulcerative esophageal squamous cell carcinoma;\n3. Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula;\n4. Patients with esophageal squamous cell carcinoma whose esophageal lesions have not been reduced after radiotherapy without surgical resection of the primary lesion;\n5. Allergy to paclitaxel and cisplatin preparations or excipient ingredients;\n6. Patients who have used paclitaxel or cisplatin in adjuvant chemotherapy and have relapsed or metastasized within six months; Note: Those who have relapsed or metastasized for more than six months can be included in the study;\n7. Previously received anti-tumor immunotherapy (including immune checkpoint inhibitors, immune cell therapy, etc.) or anti-angiogenesis targeted therapy drugs (including antibodies and small molecule tyrosine kinase inhibitors);\n8. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), but patients who have difficulty swallowing and can drink, can take Anlotinib after dissolving the granules;\n9. The burden of liver metastases accounts for more than 50% of the entire liver volume;\n10. Patients with any severe and\u002Funcontrolled diseases, including:\n\n    1. Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg); patients with grade II or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥480ms); according to NYHA standards , Grade III-IV cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%;\n    2. Active or uncontrolled serious infection;\n    3. Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;\n    4. Poor control of diabetes (fasting blood glucose (FBG)\\> 10mmol\u002FL);\n    5. Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein content is confirmed to be greater than 1.0g;\n11. Long-term unhealed wounds or fractures;\n12. Patients with esophageal squamous cell carcinoma with active bleeding within 2 months of the primary lesion; pulmonary hemorrhage with NCICTCAE grade\\> grade 1 occurred within 4 weeks before enrollment; other sites with NCICTCAE grade\\> grade 2 occurred within 4 weeks before enrollment Bleeding; patients with bleeding tendency (such as active peptic ulcer) or who are receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or their analogues;\n13. Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose of the study or expected major surgery during the study treatment period.\n14. A history of gastrointestinal perforation and\u002For fistula in the 6 months before the enrollment treatment; or arteriovenous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and lungs Embolizer\n15. There are known symptomatic central nervous system metastases and\u002For cancerous meningitis;\n16. Ascites with clinical significance, including any ascites that can be found on physical examination, ascites that has been treated in the past or still needs to be treated at present, only those with a small amount of ascites but asymptomatic on imaging can be selected;\n17. Patients with moderate pleural effusion on both sides, or large pleural effusion on one side, or patients who have caused respiratory dysfunction and require drainage;\n18. Known to have active tuberculosis;\n19. Suffer from interstitial lung disease that requires steroid therapy;\n20. Uncontrolled metabolic disorders or other non-malignant tumor organs or systemic diseases or cancer secondary reactions, which may lead to higher medical risks and\u002For uncertainty in survival evaluation;\n21. Patients with significant malnutrition, BMI\\\u003C13.6kg\u002Fm2;\n22. People who have a history of psychotropic drug abuse and cannot be quit or have mental disorders;\n23. Have a history of immunodeficiency, including those who have tested positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;\n24. History of other primary malignant tumors, except for the following: 1) Malignant tumors that have been completely remitted for at least 2 years before enrollment and no other treatment is required during the study period; 2) Non-melanoma skin that has been adequately treated and has no evidence of disease recurrence Carcinoma or malignant freckle-like nevus; 3) Carcinoma in situ that has been adequately treated and has no evidence of disease recurrence;\n25. Female patients who are pregnant or breastfeeding;\n26. According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.",{"count":239,"type":20},100,[23],"Penpulimab plus chemotherapy with or without Anlotinib as first-line therapy for patients with advanced esophageal squamous cell carcinoma (Answer): A randomized two-arm clinical study.",[26],[244],"PD-1 inhibitor\u002Fanlotinib","2024-12-26",{"date":247,"type":61},"2024-12-30",{"date":249,"type":61},"2022-09-02",{"date":251,"type":20},"2028-09-02",{"name":253,"class":68},"Nanfang Hospital, Southern Medical University",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":69},"100555464","phase-2-a-study-of-simmitinib-plus-irinotecan-in-advanced-esophageal-squamous-cell-carcinoma-100555464","NCT06512428","A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma","An Open-label, Multicenter Phase II Clinical Trial to Explore the Safety and Efficacy of Simmitinib Plus Irinotecan Liposome in Patients With Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Have fully understood and voluntarily sign the ICF for this study;\n2. Age of 18-70 years (inclusive), male or female;\n3. Esophageal squamous cell carcinoma confirmed histologically or cytologically\n4. Second-line patients with disease progression after only first-line standard therapy（Standard treatment: chemotherapy with platinum plus fluorouracil or taxane combined with immunosuppressive regimen .Progression during adjuvant\u002Fneoadjuvant therapy or within 6 months of the last dose is considered a first-line standard treatment failure）\n5. At least one measurable lesion according to RECIST 1.1;\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;\n7. Expected survival is more than 3 months\n8. Adequate organ function, defined as:\n\n   Absolute Neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 75× 10\\^9\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL\u002Fmin; Prothrombin time (PT)、activated partial thromboplastin time (APTT)、international normalized ratio(INR)≤1.5 × ULN;\n9. Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.\n\nExclusion Criteria\n\n1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;\n2. Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;\n3. Prior systemic treatment with anti-VEGF drugs, irinotecan, or any other topoisomerase I inhibitor\n4. LVEF \\\u003C50%；\n5. BMI≤18.5 kg\u002Fm\\^2\n6. Symptomatic central nervous system (CNS) metastases or meningeal metastases;\n7. Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;\n8. Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;\n9. Urine protein ≥ ++ and 24 h urine protein \\> 1.0g at screening period;\n10. Presence of any severe and\u002For uncontrolled disease before starting treatment;\n11. Severe lung disease within 6 months before first dosing ；\n12. Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;\n13. Inability to swallow drugs orally, or presence of clinically significant gastrointestinal disorders","70 Years",{"count":263,"type":20},138,[23],"To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.",[26],"2024-07-15",{"date":269,"type":61},"2024-07-22",{"date":271,"type":61},"2024-03-15",{"date":273,"type":20},"2026-01-30",{"name":275,"class":115},"Shanghai Runshi Pharmaceutical Technology Co., Ltd"]