[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fujian Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":571},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,71,0,25,[9,43,64,92,114,135,158,179,206,230,252,271,291,312,332,353,374,393,415,432,457,483,506,533,553],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100637273","a-prospective-study-on-the-clinical-value-of-skin-test-for-oxaliplatin-hypersensitivity-reaction-and-its-correlation-with-biomarkers-100637273",false,"NCT07613905","A Prospective Study on the Clinical Value of Skin Test for Oxaliplatin Hypersensitivity Reaction and Its Correlation With Biomarkers","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Patients scheduled to receive oxaliplatin-containing chemotherapy during the study.\n* Treatment-naive patients to oxaliplatin are eligible. Patients who may resume oxaliplatin treatment after prior adjuvant oxaliplatin chemotherapy can be enrolled as assessed by investigators.\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. Estimated survival time of no less than 3 months.\n* No contraindications to oxaliplatin chemotherapy.\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization, and agree to use effective contraception throughout the study and for 3 months after the last dose. Male subjects with childbearing potential female partners shall adopt reliable contraceptive measures during the study and within 3 months after final administration. Lactating women are excluded.\n* Subjects fully understand the study, voluntarily sign written informed consent, and are willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Received systemic steroid therapy exceeding 10 mg prednisone equivalent daily or other immunosuppressants within 21 days prior to enrollment; topical steroids applied to skin test area within 7 days before enrollment; anti-IL-6 monoclonal antibodies such as tocilizumab within 3 months prior to enrollment; anti-IgE monoclonal antibodies such as omalizumab within 6 months prior to enrollment.\n* Any unresolved toxicity from previous treatment not recovered to Grade 0 or 1 per NCI CTCAE Version 6.0 before enrollment, excluding alopecia and clinically insignificant asymptomatic laboratory abnormalities.\n* Known hypersensitivity to oxaliplatin or other platinum agents, ingredients and excipients of combined chemotherapeutic drugs.\n* Grade 2 or higher peripheral neuropathy prior to initial medication.\n* Active autoimmune diseases requiring systemic treatment with immunomodulators, corticosteroids or immunosuppressants. Replacement therapies including thyroxine, insulin and physiological corticosteroids for adrenal or pituitary insufficiency are permitted.\n* Uncontrolled complications, including persistent active infection or fever ≥38℃; psychiatric or social disorders that may impair study compliance, increase adverse event risks or compromise the capacity to provide informed consent.\n* Treatment with any investigational drug or participation in other clinical trials within 28 days before randomization. Enrollment is allowed if the investigational drug is deemed not to affect skin test results and relevant indicators by investigators.\n* Clinically significant underlying diseases judged by investigators to interfere with drug administration or protocol compliance.\n* Pregnant or breastfeeding females.\n* Other subjects deemed ineligible by investigators.","ALL","18 Years",{"count":19,"type":20},380,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective clinical study enrolling eligible subjects scheduled to receive oxaliplatin-based chemotherapy after signing informed consent forms.\n\nSubjects are randomly assigned to two groups. Group 1 (skin test group) receives an intradermal injection of 0.02 mL oxaliplatin solution (0.01-5.00 mg\u002FmL) before cycles 6-10 (oxaliplatin-naive patients) or cycles 2-6 (patients with recurrence after adjuvant oxaliplatin chemotherapy), with a simultaneous self-negative control (0.02 mL 0.9% normal saline). A total of 1650 person-times will be included. Group 2 (negative control group) includes 50 subjects who receive 0.02 mL 0.9% normal saline intradermally before cycle 6 or 2.\n\nAssessments include:\n\n1. Skin test results evaluated 15-30 minutes post-injection; a positive result is defined as a wheal ≥5 mm with surrounding erythema\n2. Maximum diameter of skin test rash measured 15-30 minutes post-injection\n3. Biomarker detection at three time points: pre-initial skin test, 1 hour post-skin test, and 1 hour post-first medication (carboxypeptidase A3, 9α,11β-PGF2, cysteinyl leukotrienes LTC4\u002FLTD4\u002FLTE4, IL-4\u002F5\u002F1β\u002F6\u002F8, TNF-α, MCP-1, mast cell chymase, total tryptase, ΔTryptase, ΔIL-6 peak); pre-skin test assessments include basophil activation rate, total IgE, LDH, lymphocytes, monocytes, and eosinophils\n4. Occurrence, onset time, severity (graded per NCI-CTCAE Version 5.0), and classification of oxaliplatin infusion-related hypersensitivity reactions Follow-up continues until cycle 10 (cycle 6 for oxaliplatin re-exposed patients) or the first occurrence of: hypersensitivity reaction, disease progression requiring new anti-tumor therapy, intolerable toxicity, consent withdrawal, loss to follow-up, death, or other protocol-specified termination conditions.\n\nThe negative control group is exclusively used for exploratory biomarker correlation analysis to assess the impact of skin test procedures, and is excluded from primary (sensitivity, specificity) and secondary (predictive values, likelihood ratios, Kappa coefficient) endpoint analyses. Limitations of this exploratory analysis are explicitly stated.\n\nBiomarker correlation analysis uses first skin test baseline data from 50 subjects per group (total 100 randomized cases). Variable block stratified randomization is performed, stratified by oxaliplatin-naive status and presence of comorbidities (diabetes, hypertension, renal insufficiency).",[26],"Hypersensitivity Reaction",[28,29],"Oxaliplatin","skin test","NOT_YET_RECRUITING","2026-05-22",{"date":33,"type":34},"2026-05-29","ACTUAL",{"date":36,"type":20},"2026-09-01",{"date":38,"type":20},"2029-06-01",{"name":40,"class":41},"Fujian Cancer Hospital","OTHER_GOV",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100639703","phase-3-a-clinical-study-of-ql1706-combined-with-chemotherapy-as-neoadjuvant-therapy-for-high-risk-locally-advanced-cervical-cancer-100639703","NCT07613567","A Clinical Study of QL1706 Combined With Chemotherapy as Neoadjuvant Therapy for High-Risk Locally Advanced Cervical Cancer","A Randomized, Multicenter, Phase III Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* 1\\) Age: 18-75 years; 2) Histologically confirmed cervical squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma; 3) Locally advanced disease (Stage III-IVA per FIGO 2018 staging criteria, including IIIC1\u002FIIIC2), confirmed by imaging evaluation; 4) ECOG performance status 0-1; 5) Expected to be able to complete external beam radiation therapy (EBRT) combined with brachytherapy; 6) No definite contraindications to radiotherapy; 7) Able to provide pathological specimens (≥18 qualified tissue slides) for biomarker testing; 8) No prior surgery, radiotherapy, chemotherapy, systemic therapy (including investigational drugs), or immunotherapy for cervical cancer; 9) At least one measurable lesion (per RECIST 1.1: ≥10 mm longest diameter for non-lymph node lesions on CT; ≥15 mm short axis for lymph node lesions on CT); 10) Expected survival ≥6 months; 11) Adequate major organ function. Hematology (without transfusion or blood products within 14 days): ANC ≥1.5×10⁹\u002FL; platelets ≥80×10⁹\u002FL; hemoglobin ≥9 g\u002FdL. Biochemistry: total bilirubin \\\u003C1.5×ULN; AST and ALT ≤2.5×ULN; serum creatinine ≤1.5×ULN, or creatinine clearance ≥40 mL\u002Fmin (using the standard Cockcroft-Gault formula); 12) Participants have signed informed consent and agree to comply with follow-up; 13) Women of childbearing potential must agree to use effective contraception during the study and for at least 12 months after the last dose (postmenopausal women or women not of childbearing potential are exempt).\n\nExclusion Criteria:\n\n* 1\\) Diagnosed with other malignancies within 5 years prior to first dose, excluding radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, radically excised carcinoma in situ, and\u002For papillary thyroid carcinoma; 2) Histologically confirmed small cell (neuroendocrine) cervical carcinoma, cervical carcinosarcoma, or gastric-type cervical adenocarcinoma; 3) FIGO 2018 Stage IVB disease; 4) Prior total hysterectomy (defined as removal of the entire uterus) or planned hysterectomy as part of initial cervical cancer treatment; 5) Bilateral hydronephrosis, unless at least one side has been stented or resolved by nephrostomy, or considered mild and not clinically significant by the investigator; 6) Anatomical or tumor geometric contraindications to intracavitary brachytherapy or combined intracavitary and interstitial brachytherapy, or any other contraindications; 7) Live vaccine administration within 30 days prior to first dose of study treatment; 8) Systemic immunostimulatory agents, colony-stimulating factors, interferons, interleukins, or vaccine combinations within 6 weeks or 5 half-lives (whichever is shorter) prior to Day 1 of Cycle 1; 9) Prior treatment with anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agents, or agents targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137); 10) Systemic anti-cancer therapy within 4 weeks prior to randomization, including investigational drugs; 11) Currently participating in or previously participated in a study with an investigational drug; 12) Contraindications to cisplatin use; 13) Diagnosed with immunodeficiency or receiving chronic systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to first study treatment; 14) Hypersensitivity to any study drug; 15) Active autoimmune disease requiring systemic therapy within the past 2 years; 16) History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring corticosteroids, or current pneumonitis\u002Finterstitial lung disease; 17) Active infection requiring systemic treatment; 18) Known history of human immunodeficiency virus (HIV) infection; 19) Known history of hepatitis B or known active hepatitis C viral infection; 20) Any condition, treatment, laboratory abnormality, or other circumstance that may increase risk associated with study participation or administration of study treatment, or may interfere with interpretation of study results, and judged by the investigator or sponsor to render the participant unsuitable for this study; 21) Known psychiatric or substance abuse disorders that would interfere with the participant's ability to comply with study requirements; 22) Prior allogeneic tissue\u002Fsolid organ transplantation; 23) Evidence of metastatic disease per RECIST 1.1, including lymph nodes in the inguinal region or above the level of the L1 vertebral body; 24) Women with pregnancy desire, pregnant women, or breastfeeding women.","FEMALE","75 Years",{"count":53,"type":20},486,[55],"PHASE3","This study aims to compare the efficacy and safety of \"neoadjuvant immunotherapy combined with chemotherapy followed by immunotherapy combined with radiotherapy during the radiotherapy period\" versus \"standard concurrent chemoradiotherapy\" in locally advanced cervical cancer.",[58],"Locally Advanced Cervical Carcinoma",{"date":33,"type":34},{"date":36,"type":20},{"date":62,"type":20},"2032-08-31",{"name":40,"class":41},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100638661","phase-2-efficacy-and-safety-of-dalpiciclib-combined-with-endocrine-adjuvant-therapy-for-early-hr-her2--breast-cancer-a-multicenter-prospective-clinical-study-100638661","NCT07581834","Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +\u002FHER2- Breast Cancer: a Multicenter, Prospective Clinical Study","Inclusion Criteria:\n\n1. Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal\u002Fperimenopausal.\n2. Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry showing ER ≥10% and\u002For PR ≥10%, HER2 0-1+ or HER2 ++ but negative by FISH or CISH testing, with no amplification).\n3. Patients with histologically confirmed invasive breast cancer at clinical\u002Fpathological stages II-III.\n\n   Note: For stage IIA, N1 is required, or N0 with Grade 3 or Grade 2 tumors combined with high-risk factors such as Ki-67 ≥20% or positive genetic testing (including but not limited to high-risk results in the 21-gene test). If the patient has previously received neoadjuvant therapy, the clinical stage at the time before neoadjuvant therapy must meet the above criteria.\n4. Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.\n5. The time interval from surgery to enrollment must not exceed 12 months.\n6. Patients who have received radiotherapy must have recovered from the acute effects of radiotherapy, and there must be at least 14 days of washout period from the end of radiotherapy to enrollment.\n7. Patients who have previously received chemotherapy must have recovered from the acute adverse effects of chemotherapy before enrollment (\\[CTCAE\\] grade ≤1), except for hair loss or grade 2 peripheral neuropathy.There must be a washout period of at least 21 days between the last administration of chemotherapy and enrollment in the study. 8. The Eastern Cooperative Oncology Group performance status score must be 0-1. 9. The functions of major organs must meet the following requirements: a) Blood tests: neutrophils (ANC) ≥1.5×10\\^9\u002FL; platelet count (PLT) ≥90×10\\^9\u002FL; hemoglobin (Hb) ≥90 g\u002FL. b) Blood biochemistry tests: total bilirubin (TBIL) ≤2.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; alkaline phosphatase ≤2.5×ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN. c) 12-lead electrocardiogram: QT interval corrected using the Fridericia method (QTcF) \\\u003C 470 ms in females (QTcF calculation formula: QTcF = QT\u002F(RR\\^1\u002F3)). Participants must voluntarily agree to participate in the study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up assessments.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer or recurrent\u002Fmetastatic breast cancer, or inflammatory breast cancer;\n2. A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma, etc.\n3. Participating in other clinical trials simultaneously;\n4. Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;\n5. Individuals with a known history of allergy to any component of this medication;\n6. A history of immunodeficiency, including a positive HIV test result, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n7. Any history of heart disease, including: (1) angina pectoris; (2) arrhythmias that require medical treatment or are clinically significant; (3) myocardial infarction; (4) heart failure; (5) any other heart disease deemed by the study investigators to be inappropriate for participation in this trial.\n8. Pregnant or lactating female patients; 9. Any other circumstances in which the researchers deem the participant unsuitable for participating in this study.",{"count":71,"type":20},2000,[73],"PHASE2","This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +\u002FHER2- early breast cancer. The study planned to include 2000 HR +\u002FHER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive\u002Fnegative), prior (neo) adjuvant chemotherapy (yes\u002Fno), and clinical\u002Fpathological stage (Stage II\u002FIII).\n\nCohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.",[76,77,78,79,80,81],"Breast Diseases","Breast Neoplasms","Dalpiciclib","Endocrine Breast Diseases","CDK4\u002F6 Inhibitor","HR+\u002FHER2- Breast Cancer","RECRUITING","2026-05-06",{"date":85,"type":34},"2026-05-12",{"date":87,"type":34},"2026-01-21",{"date":89,"type":20},"2032-06-30",{"name":40,"class":41},2,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100612642","phase-2-skb264-plus-ql1706-in-recurrent-or-metastatic-cervical-cancer-100612642","NCT07256236","SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer","A Single-arm, Multicenter, Phase II Study of Sacituzumab Tirumotecan (Sac-TMT\u002FSKB264) in Combination With QL1706 for Recurrent or Metastatic Cervical Cancer","Inclusion Criteria:\n\n* Female, aged ≥18 years at the time of signing the informed consent form;\n* Diagnosed with recurrent or metastatic cervical cancer \\[pathological types include squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, etc., with pathological report provided\\], and not suitable for radical treatments such as surgery or radiotherapy. Patients will be divided into the following two cohorts based on pathological type:\n\n  * Cohort 1: Cervical squamous cell carcinoma;\n  * Cohort 2: Cervical non-squamous carcinoma (including adenocarcinoma or adenosquamous carcinoma, and other types of cervical cancer)\n* Have experienced failure of at least one prior line of platinum-based standard therapy or intolerance to platinum-based drugs in the recurrent or metastatic setting, or have experienced radiologically confirmed disease progression during or within 6 months after completion (≥4 cycles) of platinum-based neoadjuvant or adjuvant chemotherapy. Specific requirements are as follows:\n\n  (a) Failure of first-line platinum-based standard therapy: meeting any one of the following criteria: i. Radiologically confirmed disease progression during treatment; ii. Radiologically confirmed disease progression after completion of treatment, provided the patient had a response (Complete Response (CR)\u002FPartial Response (PR)\u002FStable Disease (SD)) and received ≥4 cycles of treatment; (b) Investigator's judgment that the subject is intolerant to platinum-based drugs; (c) Radiologically confirmed disease progression during or within 6 months after completion (≥4 cycles) of platinum-based neoadjuvant or adjuvant chemotherapy. Weekly chemotherapy administered concurrently with radiotherapy for sensitization purposes should not be counted as chemotherapy cycles;\n* According to RECIST (v1.1) criteria, at least one measurable lesion (non-lymph node lesion with longest diameter ≥10 mm, or lymph node lesion with short diameter ≥15 mm). Lesions previously irradiated should not be selected as target lesions; unless there are no other measurable lesions available, in which case a previously irradiated measurable lesion that has shown confirmed progression radiologically may be selected as a target lesion. Subjects with only skin lesions or bone lesions are not eligible;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to dosing;\n* Expected survival period ≥12 weeks;\n* Subjects must have recovered from all toxicities resulting from prior therapy (i.e., improved to Grade 0 or 1, or to the level specified in the eligibility criteria), except for toxicities not considered a safety risk (such as alopecia, vitiligo, and other asymptomatic laboratory abnormalities). Subjects with ≤ Grade 2 neuropathy will be evaluated on a case-by-case basis in consultation with the investigator;\n* Adequate organ and bone marrow function (without transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to dosing), defined as follows:\n\n  1. Neutrophil count (NEUT#) ≥1.5×10⁹\u002FL; Platelets (PLT) ≥100×10⁹\u002FL; Hemoglobin ≥90 g\u002FL;\n  2. Liver function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 × ULN; for subjects with baseline liver metastases, ALT and AST ≤5 × ULN; Albumin ≥30 g\u002FL; Total bilirubin (TBIL) ≤1.5 × ULN;\n  3. Renal function: Creatinine clearance (Ccr) ≥50 ml\u002Fmin (calculated using the standard Cockcroft-Gault formula); Urine protein ≤1+; if urine protein ≥2+, then 24-hour urine protein quantification must be ≤1.0 g;\n  4. Coagulation function: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) ≤1.5 × ULN;\n  5. Cardiac left ventricular ejection fraction (LVEF) ≥50%.\n* For female subjects of childbearing potential, must agree to use effective medical contraception measures from the time of signing the informed consent form until 6 months after the last dose;\n* The subject voluntarily joins this study, signs the informed consent form, and is able to comply with the visits and related procedures stipulated in the protocol.\n\nExclusion Criteria:\n\n* Subjects who have had a known additional malignancy that is progressing or has required active treatment within the past 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, etc., that has undergone potentially curative therapy.\n* Subjects with known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and\u002For compression, or other active central nervous system (CNS) metastases. Subjects with brain metastases treated with local therapy may be enrolled if they meet the following criteria: clinically stable for at least 4 weeks, and no requirement for steroid treatment for at least 14 days prior to the first dose of study drug.\n* Subjects with clinically significant cardiovascular diseases, such as: a) Presence of severe or uncontrolled cardiac disease or clinical symptoms requiring treatment within 6 months prior to the first study dose, including: congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, unstable angina pectoris uncontrolled by medication, severe arrhythmia requiring drug treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia), and myocardial infarction; b) Previous history of myocarditis or cardiomyopathy; c) QTc interval \\> 480 ms based on baseline measurement.\n* Subjects with severe and\u002For uncontrolled concurrent diseases, such as decompensated liver cirrhosis, nephrotic syndrome, uncontrolled hypertension or severe hypertension, clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n* Subjects diagnosed with active Hepatitis B or Hepatitis C.\n* Subjects with known poorly controlled human immunodeficiency virus (HIV) infection, including HIV infection with a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease.\n* Subjects with known active tuberculosis.\n* Subjects with a history of severe dry eye syndrome, meibomian gland dysfunction, blepharitis, or corneal diseases that affect timely corneal healing.\n* Subjects with a known prior history of fistula of the female reproductive tract (e.g., vesicovaginal fistula, urethrovaginal fistula, vesicocervical fistula, etc.); subjects may be enrolled if the perforation or fistula has been treated with diversion surgery, resection, or repair, and the disease is considered by the investigator to have recovered or resolved.\n* Subjects who have undergone major surgery (as defined by the investigator) within 30 days prior to the first dose of study treatment or have not recovered from prior surgery.\n* Subjects with known allergy or hypersensitivity to the study drug or excipients; history of severe hypersensitivity to monoclonal antibodies.\n* Subjects with a history of interstitial lung disease (ILD), or history of non-infectious pneumonitis requiring steroid treatment, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging during screening.\n* Subjects with a history of allogeneic tissue\u002Forgan transplantation.\n* Subjects with autoimmune disease that required systemic treatment within the past 2 years or requires immunosuppressive therapy during the study period. Subjects with controlled Type 1 diabetes, thyroiditis with normal thyroid function, hypothyroidism controlled well with hormone replacement therapy (HRT), or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis) can be enrolled.\n* Subjects who have previously received TROP2-targeted therapy, or any drug containing a topoisomerase I inhibitor, including antibody-drug conjugate (ADC) therapy.\n* Subjects who have previously used any experimental anticancer vaccine, or any drug targeting T-cell co-stimulation pathways.\n* Administration of a live vaccine within 30 days prior to the first dose of study treatment, or planned administration of a live vaccine during the study.\n* Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose of study treatment or during the study.\n* Received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy within 4 weeks prior to the first dose of study treatment; received small molecule tyrosine kinase inhibitors (TKIs), antitumor hormone therapy, systemic immunostimulants (including but not limited to interferon, IL-2), or Chinese herbal patent medicines with approved anti-tumor indications within 2 weeks prior to the first dose of study treatment.\n* Received palliative radiotherapy to known metastatic sites within 2 weeks prior to the first dose of study treatment.\n* Received systemic anti-infection therapy within 1 week prior to the first dose of study treatment.\n* Any condition requiring systemic corticosteroid therapy (at doses \\>10 mg\u002Fday prednisolone or equivalent dose of similar drugs) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment. However, subjects using intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular injection), or using corticosteroids as premedication for hypersensitivity reactions can be enrolled.\n* Women who are pregnant or breastfeeding.\n* Any condition that, in the investigator's judgment, interferes with the evaluation of the study drug, the subject's safety, or the interpretation of study results, or any other circumstance that the investigator considers inappropriate for participation in this study.",{"count":100,"type":20},89,[73],"This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and QL1706 in the treatment of recurrent or metastatic cervical cancer.",[104],"Cervical Cancer","2026-03-25",{"date":107,"type":34},"2026-03-30",{"date":109,"type":34},"2026-01-28",{"date":111,"type":20},"2028-12-15",{"name":40,"class":41},14,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":134,"locationsCount":42},"100629145","phase-2-sbrt-plus-anlotinib-and-bimepolizumab-in-locally-advanced-or-metastatic-renal-cell-carcinoma-100629145","NCT07470840","SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma","A Phase II Multicenter Study of Stereotactic Body Radiation Therapy (SBRT) Combined With Anlotinib and Bimepolizumab in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Aged 18 to 80 years, regardless of sex.\n2. Histologically or cytologically confirmed locally advanced\u002Fmetastatic renal cell carcinoma (RCC) inoperable\u002Frefused for surgery, or post-operative locally recurrent\u002Fmetastatic RCC; pathological types include clear cell carcinoma and papillary renal cell carcinoma.\n3. ECOG performance status 0 or 1.\n4. At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).\n5. No contraindications to radiotherapy, targeted therapy or immunotherapy.\n6. At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Capable and willing to comply with the study protocol including scheduled visits, treatment plan, laboratory tests and other study-related procedures during the study period.\n8. Signed written informed consent form.\n\nExclusion Criteria:\n\n1. With contraindications to targeted or immunotherapeutic drugs.\n2. A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.\n3. With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.\n4. Extensive diffuse metastasis with an expected survival of less than 3 months.\n5. A history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity is judged by the investigator to potentially hinder the signing of the informed consent form or affect the patient's compliance with oral medication.\n6. With severe uncontrolled recurrent infections or other serious uncontrolled concomitant diseases.\n7. Allergic to any component of the study drugs.\n8. The subject's baseline blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥80g\u002FL; absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet ≥100×10⁹\u002FL; ALT and AST ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C2 times the upper limit of normal.","80 Years",{"count":123,"type":20},27,[73],"To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced\u002Fmetastatic renal cell carcinoma.",[127],"Locally Advanced or Metastatic Renal Cell Carcinoma","2026-03-22",{"date":130,"type":34},"2026-03-24",{"date":132,"type":20},"2027-02-01",{"date":38,"type":20},{"name":40,"class":41},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":50,"minAge":17,"maxAge":51,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100630821","phase-4-clinical-study-on-the-prevention-and-treatment-of-radiation-vaginitis-with-triethanolamine-cream-100630821","NCT07492654","Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream","Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream: An Open-label, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Age 18-75 years old;\n2. Those diagnosed with cervical cancer by histological pathology and receiving radiotherapy with a total radiation dose of ≥70Gy;\n3. ECOG score: 0-2 levels;\n4. Normal mental state and clear consciousness;\n5. Be able to cooperate with the visitor;\n6. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. Those with severe immune deficiency (such as those who have recently received bone marrow transplantation, with long-term high-dose glucocorticoids \\> 20 mg\u002F day for more than 2 weeks);\n2. Congenital vaginal malformations;\n3. Patients who are pregnant, breastfeeding, or have plans and the possibility of becoming pregnant;\n4. Other conditions that the researcher deems unsuitable for enrollment (such as: previous allergy history to triethanolamine cream, etc.).",true,{"count":144,"type":20},238,[146],"PHASE4","The objective of this clinical trial is to understand whether triethanolamine cream can prevent and treat acute radiation vaginitis. It will also learn about the safety of triethanolamine cream. The main questions it aims to answer include:\n\nCan triethanolamine cream reduce the incidence and severity of radiation vaginitis in cervical cancer patients undergoing radiotherapy?\n\nWhat medical problems might participants encounter when using triethanolamine cream?\n\nResearchers will compare triethanolamine cream with routine care to observe whether triethanolamine cream will reduce the incidence and severity of radiation vaginitis in cervical cancer patients receiving radiotherapy.\n\nParticipants will:\n\nDaily vaginal administration of triethanolamine cream, vaginal opening application and routine care, or only routine care, from the first day of radiotherapy until 28 days after the end of radiotherapy.\n\nFour examinations were conducted respectively from before radiotherapy to 90 days after its end.\n\nRecord their symptoms and conduct injury scoring.",[149,150],"Vaginitis","Radiotherapy Induced Mucositis","2026-03-19",{"date":105,"type":34},{"date":154,"type":20},"2026-03-01",{"date":156,"type":20},"2030-12-31",{"name":40,"class":41},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":42},"100628875","phase-3-dalpiciclib-combined-with-endocrine-therapy-and-metronomic-capecitabine-vs-dalpiciclib-combined-with-endocrine-therapy-for-first-line-treatment-100628875","NCT07467330","Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment","Open, Randomized Controlled Study of Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine Versus Dalpiciclib Combined With Endocrine Therapy for HR +\u002FHER2- Recurrent Metastatic Breast Cancer With Visceral Metastasis","Inclusion Criteria:\n\n1. postmenopausal or premenopausal\u002Fperimenopausal women ≥ 18 years of age who meet one of the following: a) prior bilateral oophorectomy, or ≥ 60 years of age; or b) age \\\u003C 60 years, spontaneous postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; or c) premenopausal or perimenopausal women must be willing to receive LHRH agonists between studies.\n2. Female breast cancer patients diagnosed as HR positive and HER2 negative by pathological examination are not suitable for surgical resection or radiation therapy with the purpose of cure.\n\n   A) ER-positive and\u002For PR-positive are defined as having positively stained tumor cells representing ≥ 1% of all tumor cells (reviewed and confirmed by the investigator at the site); b) HER2-negative are defined as having 0\u002F1 + by standard immunohistochemistry (IHC); HER2\u002FCEP17 ratio of less than 2.0 by ISH or HER2 gene copy number of less than 4 (reviewed and confirmed by the investigator at the site).\n3. ECOG score 0-2.\n4. Patients with new stage IV or recurrent metastases with visceral metastases are allowed to enroll patients with visceral crisis (visceral crisis definition includes but is not limited to meeting one of the following: pleural effusion; ascites; abdominal pain caused by liver or peritoneal metastases; rapid worsening of dyspnea at rest that cannot be relieved by pleural effusion drainage; rapid increase in bilirubin \\> 1.5 × ULN in the absence of Gilbert 's syndrome or biliary obstruction).\n5. adequate bone marrow function, defined as follows: a) neutrophil count (ANC) ≥ 1,500\u002Fmm3 (1.5 x 109 L) (no growth factors used within 14 days); b) platelet count (PLT) ≥ 100,000\u002Fmm3 (100 x 109 L) (no corrective treatment used within 7 days); c) hemoglobin (Hb) ≥ 8 g\u002FdL (80 g\u002FL) (no corrective treatment used within 14 days).\n6. Female subjects who are not postmenopausal or surgically sterile must have a negative serum pregnancy test within 7 days before the first dose and are willing to abstain from sexual intercourse or use a medically recognized highly effective contraceptive measure after signing informed consent, during the study, and for 1 year after the last dose of study drug.\n7. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. patients who have previously been treated with CDK4\u002F6 inhibitors and\u002For capecitabine.\n2. patients who relapse within 2 years of adjuvant endocrine therapy.\n3. Patients with bone metastases alone regardless of recurrence, metastasis or new stage IV disease.\n4. patients with active brain metastases.\n5. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), hepatitis B surface antigen positive and HBV DNA ≥ 2000 IU\u002Fml, hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method) or combined hepatitis B and hepatitis C co-infection.\n6. The following conditions occurred 6 months before enrollment: myocardial infarction, severe\u002Funstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, ≥ grade 2 persistent arrhythmia (according to NCI CTCAE version 5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack) or symptomatic pulmonary embolism, and new thrombosis.\n7. Complicated with severe infection within 4 weeks before the first dose (such as intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment specifications), or unexplained fever \\> 38.5℃ during screening\u002Fbefore the first dose.\n8. inability to swallow, bowel obstruction, or the presence of other factors that affect the administration and absorption of the drug.\n9. known hypersensitivity to regimen combination therapy drugs and any of their excipients.\n10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n11. Known history of psychotropic substance abuse or drug abuse.\n12. Female patients who are pregnant or lactating.\n13. Any other condition that the investigator considers the subject unsuitable for participation in this study.",{"count":166,"type":20},258,[55],"This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +\u002FHER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).",[170],"Breast Cancer","2026-03-11",{"date":173,"type":34},"2026-03-12",{"date":175,"type":34},"2025-11-15",{"date":177,"type":20},"2032-12-31",{"name":40,"class":41},{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},"100629027","phase-2-short-course-rt-plus-capox-and-tislelizumab-vs-long-course-crt-plus-tislelizumab-for-locally-advanced-rectal-cancer-100629027","NCT07469306","Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer","Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Age 18-75 years, any gender.\n* Pathologically confirmed rectal adenocarcinoma.\n* Baseline MR stage T3-4\u002FN+.\n* Distance from anal verge ≤12cm.\n* No distant metastasis.\n* Karnofsky Performance Status ≥70.\n* Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.\n* Microsatellite\u002Fmismatch repair status MSS\u002FpMMR.\n* No prior chemotherapy or any other anti-tumor treatment before inclusion.\n* No prior immunotherapy.\n* Ability to comply with the study protocol during the study period.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Pathological diagnosis of signet ring cell carcinoma.\n* History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.\n* Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.\n* Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.\n* Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.\n* Patients with autoimmune diseases.\n* Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.\n* Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g\u002FL; absolute neutrophil count (ANC) .≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP\n\n  ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C1 times the upper limit of normal; serum albumin ≥30g\u002FL.\n* Known deficiency of dihydropyrimidine dehydrogenase (DPD).\n* Allergy to any investigational drug components.",{"count":187,"type":20},130,[73],"To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.",[191],"Locally Advanced Rectal Cancer",[193,194,195,196],"Modified Short-course radiotherapy (mSCRT)","Long-course radiotherapy (LCRT)","CAPOX","PD-1 monoclonal antibody","2026-03-10",{"date":199,"type":34},"2026-03-13",{"date":201,"type":20},"2026-08-10",{"date":203,"type":20},"2027-09-01",{"name":40,"class":41},3,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":213,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":91},"100576583","phase-2-scrtshort-course-radiotherapy-combined-with-capox-plus-ql1706-for-rectal-cancer-liver-metastases-100576583","NCT06787183","SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases","A Phase II Multicenter Clinical Trail of Efficacy and Safety of Short Course Radiotherapy Combined With CAPOX and PD-1\u002FCTLA-4 Bispecific Antibody QL1706 in Patients With Liver Metastases From Rectal Cancer","Inclusion Criteria:\n\n1. Age 18-75 years, any gender.\n2. Pathologically confirmed rectal cancer with liver metastases (stage M1).\n3. Karnofsky Performance Status ≥70.\n4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy.\n5. Microsatellite\u002Fmismatch repair status MSS\u002FpMMR.\n6. No prior chemotherapy or any other anti-tumor treatment before inclusion.\n7. No prior immunotherapy.\n8. Ability to comply with the study protocol during the study period.\n9. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Pathological diagnosis of signet ring cell carcinoma.\n3. History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.\n4. Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.\n5. Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.\n6. Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.\n7. Patients with autoimmune diseases.\n8. Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.\n9. Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g\u002FL; absolute neutrophil count (ANC) .≥1.5×10\\^9\u002FL; platelets ≥100×10\\^9\u002FL; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \\\u003C1.5 times the upper limit of normal; serum creatinine \\\u003C1 times the upper limit of normal; serum albumin ≥30g\u002FL.\n10. Known deficiency of dihydropyrimidine dehydrogenase (DPD).\n11. Allergy to any investigational drug components.",{"count":214,"type":20},42,[73],"To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.",[218],"Locally Advanced Rectal Cancer With Liver Metastases",[220,195,221],"short course radiotheraphy","QL1706 (bifunctional PD1\u002FCTLA4 dual blocker)","2026-02-28",{"date":224,"type":34},"2026-03-03",{"date":226,"type":34},"2025-12-01",{"date":228,"type":20},"2029-12-01",{"name":40,"class":41},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100623632","crossroad-treatment-regimen-switch---re-induction-chemotherapy-vs-direct-radiotherapy-in-lanpc-with-inadequate-response-to-induction-chemotherapy-100623632","NCT07399158","CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Response to Induction Chemotherapy","CROSSROAD: A Prospective Multicenter Observational Study on the Efficacy of Treatment Regimen Switch With Re-induction Chemotherapy Versus Direct Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Inadequate Response (SD\u002FPD) After Induction Chemotherapy","Inclusion Criteria:\n\nAge: 18 to 70 years old.\n\nHistologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II\u002FIII).\n\nInitial treatment with no distant metastasis: Locally advanced nasopharyngeal carcinoma (according to the AJCC\u002FUICC 9th edition staging, stage II-III, i.e., T3-4N0-3M0 or T1-2N2-3M0).\n\nCompletion of two cycles of standard induction chemotherapy (such as TPF, GP, TP, etc.).\n\nPost-induction chemotherapy evaluation: Disease stability (SD) or disease progression (PD) after two cycles of induction chemotherapy, as assessed by RECIST 1.1 criteria, based on enhanced MRI of the nasopharynx.\n\nECOG Performance Status (PS): 0-1.\n\nBone marrow, liver, and kidney function: Sufficient to tolerate concurrent chemoradiotherapy (specific criteria to be referenced).\n\nInformed consent: Voluntary participation in the study and signing of written informed consent.\n\nExclusion Criteria:\n\nHistory of head and neck tumor radiotherapy or any other malignant cancer history (except for cured non-melanoma skin cancer).\n\nPartial response (PR) or complete response (CR) after induction chemotherapy.\n\nSevere uncontrolled comorbidities, such as unstable angina, congestive heart failure, severe chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes mellitus.\n\nActive infection or severe immunodeficiency diseases.\n\nPregnant or breastfeeding women.\n\nAny mental or social disorders that may interfere with study evaluation or compliance.\n\nOther conditions deemed by the investigator to be unsuitable for participation in the study.","70 Years",{"count":239,"type":20},223,"OBSERVATIONAL","This study aims to compare the efficacy of two treatment strategies-re-induction chemotherapy followed by radiotherapy versus direct radiotherapy-in patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. The study will enroll patients who have completed two cycles of induction chemotherapy and have not achieved a partial or complete response. Participants will receive one of the two treatment options to evaluate their three-year progression-free survival (PFS) and other clinical outcomes.",[243],"Nasopharyngeal Carcinoma","2026-02-07",{"date":246,"type":34},"2026-02-10",{"date":248,"type":20},"2026-02-01",{"date":250,"type":20},"2030-02-01",{"name":40,"class":41},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100622839","phase-2-timing-optimization-of-immunotherapy-during-neoadjuvant-chemotherapy-for-locally-advanced-nasopharyngeal-carcinoma-100622839","NCT07388836","Timing Optimization of Immunotherapy During Neoadjuvant Chemotherapy for Locally Advanced Nasopharyngeal Carcinoma","A Multicenter, Randomized, Phase II Clinical Trial to Optimize the Timing of Immune Checkpoint Inhibitor Administration During Neoadjuvant Chemotherapy in Patients With Locally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Age between 18 and 70 years\n\nHistologically confirmed locoregionally advanced nasopharyngeal carcinoma (AJCC\u002FUICC 8th edition stage II-III)\n\nAt least one measurable target lesion per RECIST 1.1\n\nECOG performance status of 0-1\n\nEstimated life expectancy ≥ 6 months\n\nAdequate hematologic, hepatic, renal, and coagulation function\n\nNegative pregnancy test for women of childbearing potential\n\nWillingness to use effective contraception during the study and for 12 months after treatment\n\nSigned informed consent\n\nWilling and able to comply with study procedures\n\nNot participating in any other interventional clinical trials during the study period\n\nExclusion Criteria:\n\n* re first dose\n\nActive or suspected autoimmune disease requiring systemic treatment\n\nOngoing systemic immunosuppressive therapy\n\nActive hepatitis B, hepatitis C, HIV infection, or other serious infections\n\nHistory of another malignancy within 5 years (except non-melanoma skin cancer or in situ cervical cancer)\n\nPregnant or breastfeeding women\n\nInability or unwillingness to use contraception as required\n\nLife expectancy \\\u003C 6 months",{"count":260,"type":20},198,[73],"This is a multicenter, open-label, randomized phase II clinical trial designed to evaluate the optimal timing of toripalimab administration during neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin (GP) chemotherapy combined with toripalimab administered on different days (Day 1, Day 5, or Day 9) to compare treatment responses. The neoadjuvant phase includes 3 cycles of 21 days each, followed by concurrent chemoradiotherapy. The estimated enrollment period is from March 2026 to March 2028.",[264],"Locally Advanced Nasopharyngeal Carcinoma",{"date":266,"type":34},"2026-02-05",{"date":154,"type":20},{"date":269,"type":20},"2028-05",{"name":40,"class":41},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":4},"100618423","phase-2-mrg003-induction-and-capecitabine-maintenance-with-pd-1-in-locally-recurrent-npc-100618423","NCT07331428","MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC","Efficacy and Safety of MRG003 With PD-1 Induction Followed by Capecitabine and PD-1 Maintenance as First-line Treatment in Locally Recurrent Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n\\*\\*Inclusion Criteria:\\*\\*\n\n1. Patients with locally recurrent nasopharyngeal carcinoma (NPC) more than 1 year after initial radical treatment for non-metastatic NPC, with or without regional recurrence, but without distant metastasis.\n2. Age 18-70 years.\n3. Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC\u002FUICC classification.\n4. ECOG performance status score of 0-1.\n5. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent NPC.\n6. No contraindications to immunotherapy or chemotherapy.\n7. Adequate organ function.\n\nExclusion Criteria:\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n1. Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1\u002FPD-L1 resulting in Grade III or higher immune-related adverse reactions.\n2. Residual toxic effects from prior anti-tumor treatments (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy) (excluding alopecia, fatigue, and Grade 2 hypothyroidism) or clinically significant laboratory abnormalities higher than Grade 1 (CTCAE v5.0).\n3. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥10 copies\u002Fml), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the assay).\n4. Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.",{"count":7,"type":20},[73],"This study enrolls patients who have experienced local recurrence of nasopharyngeal carcinoma (NPC) with or without regional recurrence. The treatment regimen includes an induction phase with MRG003 at 2.0 mg\u002Fkg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. This is followed by maintenance therapy consisting of Capecitabine (650 mg\u002Fm², twice daily on days 1-21) in combination with Tislelizumab, continued for up to 1 year or until disease progression.",[243,282],"Local Recurrence","2025-12-28",{"date":285,"type":34},"2026-01-09",{"date":287,"type":20},"2026-01-01",{"date":289,"type":20},"2029-12-31",{"name":40,"class":41},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":298,"targetDuration":4,"studyType":21,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":42},"100617552","phase-4-postoperative-radiotherapy-for-postoperative-n2-metastases-of-nsclc-in-the-immunotherapy-era-phase-ii-100617552","NCT07320105","Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II)","Efficacy of Postoperative Radiotherapy in Patients With Multiple Postoperative N2 Metastases From Non-Small Cell Lung Cancer in the Immunotherapy Era: A Multicenter Prospective Controlled Phase II Clinical Trial","Inclusion Criteria:\n\n* Age: ≥18 years old and ≤75 years old, no gender restriction; Pathologically (histologically or cytologically) confirmed non-small cell lung cancer with multiple N2 metastasis after surgery; No prior radiotherapy, chemotherapy or immunotherapy; At least 3 lymph node metastases confirmed by postoperative pathology; ECOG PS score: 0-2; Expected survival time ≥3 months; Normal major organ function, with basically normal results of blood routine, blood biochemistry and coagulation function tests; Basically normal immune indicators; No severe underlying diseases or severe cardiopulmonary dysfunction.\n\nExclusion Criteria:\n\n* Known or suspected active autoimmune diseases, or history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.); History of immunodeficiency (including positive HIV test), other acquired\u002Fcongenital immunodeficiency diseases, organ transplantation or allogeneic bone marrow transplantation; Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, symptomatic active pneumonia, or severe pulmonary dysfunction; Poorly controlled cardiovascular symptoms or diseases (e.g., NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmia); Active hepatitis B (HBV DNA ≥2000 IU\u002FmL or 10⁴ copies\u002FmL) or hepatitis C (positive anti-HCV and HCV-RNA above detection limit); Hereditary bleeding tendency or coagulation dysfunction; bleeding symptoms within 3 months, or positive fecal occult blood (++ or above); Toxicity from prior anti-tumor therapy not recovered to ≤CTCAE grade 1 (except alopecia); Known or suspected allergy to the study drug; Pregnant or lactating women; Subjects deemed unsuitable for inclusion by the investigator.",{"count":299,"type":20},60,[146],"This study will be conducted at Fujian Provincial Cancer Hospital. Its main goals are to evaluate the progression-free survival (PFS) and safety of postoperative immunotherapy combined with radiotherapy in patients with high-risk stage Ⅲ N2 non-small cell lung cancer after surgery. It will also assess the overall survival (OS) of this treatment as a secondary goal.\n\nThis study has been approved by the Medical Ethics Committee of Fujian Provincial Cancer Hospital, and the rights and safety of all participants will be fully protected during the trial.",[303],"Non-Small Cell Lung Cancer","2025-12-22",{"date":306,"type":34},"2026-01-06",{"date":308,"type":20},"2026-01-15",{"date":310,"type":20},"2029-01-31",{"name":40,"class":41},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100617021","phase-2-ivarmacitinib-in-advanced-solid-tumors-a-prospective-two-cohort-two-phase-exploratory-study-in-patients-discontinued-due-to-immune-intolerance-100617021","NCT07313202","Ivarmacitinib in Advanced Solid Tumors: A Prospective, Two-Cohort, Two-Phase Exploratory Study in Patients Discontinued Due to Immune Intolerance","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. ECOG performance status score 0-1.\n3. Expected survival ≥ 12 weeks.\n4. Solid tumor patients who have discontinued treatment with immune checkpoint inhibitors (ICIs).\n5. Treatment with ICIs may be administered as monotherapy or in combination with other therapies (including but not limited to radiotherapy, chemotherapy, targeted therapy, etc.).\n6. Current Status of irAE:\n\n   Cohort I:\n   1. Patients currently diagnosed with steroid-resistant or steroid-dependent immune-related adverse events (immune myocarditis, immune colitis, immune myositis-arthritis, immune skin reactions, immune hepatitis, etc.);\n   2. Patients with contraindications to steroid use, or who refuse continued steroid therapy due to adverse reactions following steroid administration.\n\n   Cohort II:\n   1. Patients discontinued immunotherapy due to irAE (CTCAE 5.0) after receiving ≥1 line of treatment including ICIs;\n   2. Time since discontinuation of immunotherapy due to irAE ≤3 months;\n   3. irAE has resolved to ≤Grade 1.\n7. The patient still possesses certain organ and bone marrow functions:\n\n   Cohort 1:\n   1. Hemoglobin ≥90 g\u002FL, neutrophil count ≥1.0 × 10\\^9\u002FL, platelet count ≥75 × 10\\^9\u002FL; lymphocyte count ≥0.5 × 10\\^9\u002FL; coagulation function: INR, APTT, and PT all ≤1.5 × UNL;\n   2. Liver function: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 × ULN, alanine aminotransferase (ALT) ≤ 3 × ULN. For patients with immune hepatitis, specific liver function biochemical parameters are not restricted; adequate liver function is defined as Child-Pugh class A-B;\n   3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin;\n   4. Or patients assessed by the investigator as having adequate organ function.\n\n   Cohort II:\n\n   Organ function levels must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy within 2 weeks prior to blood screening):\n   1. ANC ≥ 1.5 × 10⁹\u002FL;\n   2. PLT ≥ 100 × 10⁹\u002FL;\n   3. Hb ≥ 90 g\u002FL;\n   4. TBIL ≤ 1.0 × ULN;\n   5. ALT and AST ≤ 2.5 × ULN;\n   6. BUN and Cr ≤ 1.5 × ULN.\n8. All women of childbearing potential must have a negative serum pregnancy test during the screening period and must use reliable contraception from signing the informed consent form until 3 months after the last dose.\n9. Subjects voluntarily participate in this study, sign the informed consent form prior to the screening process, demonstrate good compliance, and cooperate with safety follow-up.\n10. The subject is judged by the investigator to be able to adhere to the study protocol.\n\nExclusion Criteria:\n\n* 1\\) Individuals with allergic diseases, a history of severe drug allergies, or potential hypersensitivity to Ivarmacitinib or its components; 2) Patients diagnosed with an embolic event within 3 months prior to enrollment, excluding superficial venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism, embolic stroke, myocardial infarction, or peripheral arterial insufficiency); 3) Patients with severe non-irAE-related cardiac, hepatic, renal, or systemic diseases; 4) Patients with active tuberculosis or who received live vaccines during the illness period; 5) Patients with uncontrolled infectious diseases; 6) Patients with moderate to severe heart failure (NYHA Class III\u002FIV); 7) Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) exceeding 500 IU\u002FmL or 1000 copies per milliliter (cps\u002FmL); Hepatitis C virus (HCV) antibody (HCV-Ab) positive with HCV RNA quantitative levels exceeding the upper limit of normal for the assay; HIV antibody (Anti-HIV) positive; active syphilis. Meeting any one of the above criteria.\n\n  8\\) Previous treatment with JAK inhibitors prior to enrollment (for Cohort 1: ≤30 days of prior JAK inhibitor use, irAE resolution ≤ Grade 1, and investigator assessment permitting ICI restart; eligible for Cohort 2); 9) Cohort 2 participants with prior ICI restart therapy, including but not limited to PD-1\u002FPD-L1 inhibitors, CTLA-4 inhibitors, etc.; 10) Patients receiving intravenous biologic therapy for other baseline autoimmune diseases; 11) Pregnant or lactating females, and males or females unwilling to use contraception; 12) Psychiatric disorders impairing study compliance; 13) Subjects deemed unsuitable for this study by the investigator shall be excluded, such as those judged to have other factors that may necessitate premature termination of the study. These include: - Concurrent treatment for other serious illnesses (including psychiatric disorders) - Severe laboratory abnormalities - Family or social circumstances that may compromise subject safety or interfere with data\u002Fsample collection.",{"count":319,"type":20},72,[73],"This study is a Phase II, two-cohort, multicenter, two-stage clinical trial. It plans to enroll 72 subjects with solid tumors who discontinued prior ICI therapy due to irAE. Cohort 1 enrolls subjects with irAE resistant to or dependent on corticosteroid therapy. Subjects in Cohort 1 who achieve ≤ Grade 1 irAE resolution following treatment may then enroll in Cohort 2. Cohort 2 enrolls subjects with irAE achieving ≤ Grade 1 resolution following treatment, and deemed eligible for ICI re-initiation by the investigator. Phase I is the safety run-in phase, enrolling 6 subjects per cohort. Phase II is the expansion phase, enrolling 30 subjects per cohort.",[323],"Patients With Advanced Solid Tumors Who Discontinued Treatment Due to irAE","2025-12-17",{"date":326,"type":34},"2025-12-31",{"date":328,"type":20},"2025-12-10",{"date":330,"type":20},"2028-12-26",{"name":40,"class":41},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100616835","phase-2-sintilimab-nimotuzumab-induction-followed-by-chemoradiation-nimotuzumab-in-la-hnscc-single-arm-phase-ii-100616835","NCT07310771","Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase II","A Single-Arm Phase II Study of Sintilimab Plus Nimotuzumab and Chemotherapy Followed by Definitive Chemoradiotherapy With Nimotuzumab for Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Provision of written informed consent, with full understanding of and agreement to comply with study requirements and the visit schedule.\n2. Age 18-75 years (inclusive) at the time of informed consent; either sex.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n4. Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of the head and neck as assessed by the investigator.\n5. Documented EGFR-positive tumor.\n6. No prior systemic therapy for head and neck squamous cell carcinoma.\n7. At least one measurable lesion per RECIST v1.1.\n8. Estimated life expectancy ≥ 12 weeks.\n9. Adequate bone-marrow and organ function.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of PD(L)-1 inhibitors, paclitaxel, or cisplatin.\n2. Prior or concurrent malignancy (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma disease-free for \\>5 years).\n3. Uncontrolled cardiac symptoms or clinically significant cardiac disease.\n4. Previous therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or receipt of therapeutic cancer vaccines or live vaccines within 4 weeks before first study-dose administration.\n5. Failure to recover to ≤ Grade 1 (per CTCAE) from prior anti-tumour therapy-except alopecia or residual neurotoxicity related to prior platinum-before first study dose.\n6. Severe infection (\\> CTCAE Grade 2) within 4 weeks before first study dose.\n7. Active autoimmune disease or documented autoimmune-disease history requiring systemic therapy.\n8. History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency syndromes, or prior solid-organ or allogeneic bone-marrow transplantation.\n9. History of interstitial lung disease or non-infectious pneumonitis.\n10. Evidence of active tuberculosis infection on history or CT imaging.\n11. Active hepatitis B (HBV DNA ≥ 500 IU\u002FmL or ≥ 2,500 copies\u002FmL).\n12. History of substance abuse, alcohol abuse, or drug addiction.\n13. Pregnant or lactating women.\n14. Any condition that, in the investigator's opinion, could necessitate premature withdrawal from the study.",{"count":340,"type":20},23,[73],"Although multiple immune-checkpoint inhibitors (ICIs) have demonstrated efficacy in recurrent or metastatic squamous-cell carcinoma of the head and neck (R\u002FM-SCCHN), outcomes in the locally advanced (LA-SCCHN) setting remain suboptimal, and treatment continues to pose a major therapeutic challenge. Incremental improvements in efficacy are still required, necessitating the development of more effective regimens. Whether combining an ICI with chemotherapy and nimotuzumab can confer additional clinical benefit in LA-SCCHN remains to be determined. Against this backdrop, we designed a single-arm, phase II, single-centre clinical trial to evaluate the efficacy and safety of sintilimab plus chemotherapy and nimotuzumab for patients with LA-SCCHN.",[344],"Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)","2025-12-16",{"date":347,"type":34},"2025-12-30",{"date":349,"type":20},"2026-01-10",{"date":351,"type":20},"2029-07-10",{"name":40,"class":41},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":4},"100616505","the-efficacy-of-preoperative-oral-administration-of-lactobacillus-reuteri-combined-with-preoperative-neoadjuvantconversion-immunotherapy-in-patients-with-primary-resectable-liver-cancer-100616505","NCT07306481","The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant\u002FConversion Immunotherapy in Patients With Primary Resectable Liver Cancer","The Efficacy of Preoperative Oral Administration of Lactobacillus Reuteri Combined With Preoperative Neoadjuvant\u002FConversion Immunotherapy in Patients With Primary Resectable Liver Cancer: a Prospective Study","Inclusion Criteria:\n\n1. Understanding and voluntarily signing the informed consent form for this study;\n2. Age≥18 years and ≤75 years; gender not restricted;\n3. Histologically (pathologically), cytologically, or radiologically confirmed hepatocellular carcinoma (HCC);\n4. Patients who require preoperative immune checkpoint inhibitor (ICI) combination therapy followed by potentially curative hepatectomy;\n5. No prior systemic therapy for HCC, including chemotherapy, targeted therapy, or immunotherapy had been administered before enrollment.;\n6. Patients with a history of prior curative surgery or curative ablation are allowed, except for those with recurrence within 2 years post-curative treatment or prior receipt of other local therapies;\n7. At least one measurable lesion meets RECIST v1.1 criteria;\n8. Child-Pugh liver function rating: grade A or B;\n9. The expected survival period is greater than 3 months;\n10. Patients must be able to take food orally independently;\n11. Preoperative ECOG physical condition score 0-1 points;\n12. Normal coagulation function, no activebleeding or thrombotic diseases; A. International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time APTT≤1.5×ULN;\n13. Has adequate organ and bone marrow function, laboratory test values within 7 days prior to enrollment meet the following requirements (no blood components, cell growth factors, albumin, or other corrective drugs are allowed within 14 days prior to laboratory test), as follows: 1) Blood routine: absolute neutrophil count≥1.5×109\u002FL; platelet count≥75×109\u002FL; hemoglobin conten≥9.0 g\u002FdL. 2) Liver function: serum total bilirubin≤2× upper limit of normal value (ULN); alanine aminotransferase and aspartate transferas≤5×ULN; Serum albumin ≥28 g\u002FL; alkaline phosphatase≤5×ULN. 3) Renal function: serum creatinine≤1.5×ULN or clearance of creatinine≥50mL\u002Fmin(Cockcroft-Gault formula); Urine routine results showed that urine protein \\\u003C2+; For patients with urine protein ≥2+ on routine urine tests at baseline, 24-hour urine collection and 24-hour protein quantification \\\u003C1g should be performed.\n\nExclusion Criteria:\n\n1. Inability to comply with the study protocols or procedures;\n2. Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma (ICC more than 30%) and fibrolaminar cell carcinoma\n3. Hepatic encephalopathy, hepatorenal syndrome, or severe decompensated cirrhosis;\n4. Planned use of probiotics, yogurt, or bacterial-fortified foods during the treatment period;\n5. Use of probiotics or antibiotic within 2 months before the trial;\n6. Patients with severe mental illness;\n7. Patients under fasting or fluid restriction (e.g., complete bowel obstruction, active gastrointestinal bleeding, etc.);\n8. Patients with chronic digestive system diseases, such as irritable bowel syndrome, malabsorption syndrome, inflammatory bowel disease, or ileostomy;\n9. Allergy to the trial product or its components, inability to swallow tablets, unwillingness or inability to receive intravenous administration, or a history of severe infusion-related reactions to monoclonal antibodies or any other active malignancies during the initial study treatment administration;\n10. Participants in other drug, dietary supplement, probiotic, or prebiotic clinical studies within the past 1 months prior to enrollment\n11. Pregnant or lactating women;\n12. History of other malignancies within the past 5 years, except for completely resected basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ;\n13. Any medical or non-medical condition that the researcher deems unsuitable for participation.",{"count":361,"type":20},40,[23],"On the basis of previous studies, this study intends to explore the efficacy of preoperative oral administration of Lactobacillus reuteri (Lr) combined with preoperative neoadjuvant\u002Fconversion therapy in patients with primary resectable hepatocellular carcinoma (HCC). We hypothesize that this combination represents a novel, microbiota-based therapeutic strategy to facilitate perioperative hepatic recovery and improve long-term survival outcomes.\n\nThis study is an open-label, randomized, blank-controlled clinical trial. Patients undergoing liver resection were randomly allocated to one of two groups. The intervention group received preoperative oral Lactobacillus reuteri (Lr) supplementation alongside neoadjuvant\u002Fconversion immunotherapy. The control group received preoperative neoadjuvant\u002Fconversion immunotherapy alone. Fecal and peripheral blood samples will be collected at baseline (pre-medication), 3 days prior to surgery, and at 5 days, 1, 3, 6, 9, 12, 18, and 24 months postoperatively. Intraoperative liver tissue samples will also be obtained. Statistical analyses will be performed to compare intergroup differences in postoperative liver function recovery, overall survival, hepatic and peripheral immune markers, and gut microbiota composition.\n\nThis study aims to develop adjuvant strategies to enhance therapeutic outcomes for HCC patients undergoing preoperative neoadjuvant\u002Fconversion immunotherapy.",[365],"HCC - Hepatocellular Carcinoma","2025-12-14",{"date":368,"type":34},"2025-12-29",{"date":370,"type":20},"2025-12-20",{"date":372,"type":20},"2028-12-20",{"name":40,"class":41},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":391,"leadSponsor":392,"locationsCount":42},"100613599","phase-3-risk-adapted-omission-of-level-va-irradiation-in-nasopharyngeal-carcinoma-100613599","NCT07268690","Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma","Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority Trial","Inclusion Criteria:\n\n1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;\n2. No distant metastatic;\n3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;\n4. Signing informed consent;\n5. Follow up regularly and comply with test requirements.\n\nExclusion Criteria:\n\n1. Ipsilateral Level IIb involvement;\n2. Ipsilateral Level III nodes involvement;\n3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c);\n4. Disease progression during IMRT;\n5. Previous malignancy or other concomitant malignant diseases;\n6. The evaluation information of tumor efficacy can not be obtained;\n7. Receive blind treatment in other clinical research;\n8. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);\n9. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;\n10. Active systemic infection;\n11. No or limited capacity for civil conduct;\n12. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;\n13. Pregnancy or lactation period;",{"count":382,"type":20},474,[55],"This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.",[386],"Nasopharyngeal Carcinoma by AJCC V9 Stage","2025-11-25",{"date":389,"type":34},"2025-12-08",{"date":287,"type":20},{"date":156,"type":20},{"name":40,"class":41},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":400,"targetDuration":4,"studyType":21,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":4},"100612345","phase-2-a-clinical-study-of-hetrombopag-for-prevention-of-thrombocytopenia-induced-by-gemcitabine-plus-cisplatin-in-the-treatment-of-nasopharyngeal-carcinoma-100612345","NCT07252375","A Clinical Study of Hetrombopag for Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma","A Single-Arm, Exploratory, Self-Controlled Clinical Study of Hetrombopag for Secondary Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* 1\\. Aged 18 to 75 years old, regardless of gender;\n* 2\\. Patients with nasopharyngeal carcinoma confirmed by pathological or cytological examination;\n* 3\\. Currently receiving treatment with the Gemcitabine + Cisplatin (GP) regimen at a 21-day cycle, with the lowest platelet count \\\u003C 75×10⁹\u002FL in the previous chemotherapy cycle, and expected to maintain the same chemotherapy regimen for at least 2 more cycles;\n* 4\\. Estimated survival time ≥ 12 weeks;\n* 5\\. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2;\n* 6\\. Laboratory test indicators meeting the following requirements:\n\n  1. Absolute Neutrophil Count (ANC) \\> 1.0×10⁹\u002FL, Hemoglobin (Hb) \\> 80 g\u002FL;\n  2. Renal function: Creatinine (Cr) ≤ 1.5 × Upper Limit of Normal (ULN) or estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml\u002Fmin (calculated by the Cockcroft-Gault formula);\n  3. Liver function: Total Bilirubin (TBIL) ≤ 1.5 × ULN; Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; (If the patient has intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN);\n  4. Coagulation function: International Normalized Ratio (INR) of Prothrombin Time (PT) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) within the normal range;\n* 7\\. Females of childbearing potential must agree to use contraception during the study and for 6 months after the study ends; non-lactating females are eligible. Males must agree to use contraception during the study and for 6 months after the study ends;\n* 8\\. No participation in other clinical trials of drugs within 4 weeks prior to enrollment;\n* 9\\. Subjects must understand the study details and voluntarily sign the Informed Consent Form (ICF);\n* 10\\. No severe complications such as active massive gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or non-cancerous fever \\> 38℃;\n* 11\\. Expected to have good compliance and be able to complete follow-up for efficacy and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* 1\\. Thrombocytopenia not caused by cancer therapy occurring within 6 months prior to screening, including but not limited to hepatic cirrhosis with hypersplenism, infection, and bleeding;\n* 2\\. Having other hematopoietic system diseases besides chemotherapy-induced thrombocytopenia, including leukemia, primary immune thrombocytopenia (ITP), myeloproliferative diseases (MPDs), multiple myeloma (MM), myelodysplastic syndromes (MDS), etc.;\n* 3\\. Complicated with bone marrow involvement or bone marrow metastasis;\n* 4\\. Having received pelvic, spinal radiotherapy or large-field bone irradiation within 3 months prior to screening;\n* 5\\. History of any arterial or venous thrombosis occurring within 6 months prior to screening;\n* 6\\. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within 2 weeks prior to screening;\n* 7\\. Severe cardiovascular diseases (e.g., NYHA Cardiac Function Classification Grade III-IV) within 6 months prior to screening, or patients with arrhythmias known to increase thromboembolic risk (such as atrial fibrillation \\[AF\\]), history of coronary artery stenting, angioplasty, or coronary artery bypass grafting (CABG);\n* 8\\. Brain tumor or brain metastasis;\n* 9\\. Having received platelet transfusion within 2 days prior to enrollment;\n* 10\\. Having received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonist drugs (such as eltrombopag, avatrombopag) within 5 days prior to screening;\n* 11\\. Patients with known or anticipated allergy or intolerance to the active ingredient or excipients of Hetrombopag Ethanolamine Tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose \\[L-HPC\\], magnesium stearate, film-coating premix);\n* 12\\. Pregnant or lactating women;\n* 13\\. Patients deemed ineligible for enrollment by the investigator.",{"count":401,"type":20},35,[73],"This study is a single-arm, exploratory, self-controlled clinical trial for the prevention of thrombocytopenia induced by gemcitabine plus cisplatin in the treatment of nasopharyngeal carcinoma. It aims to investigate the efficacy and safety of hetrombopag for the secondary prevention of thrombocytopenia caused by gemcitabine plus cisplatin in patients with nasopharyngeal carcinoma. The study protocol has been reviewed and approved by the Institutional Ethics Committee of Fujian Cancer Hospital, allowing the conduct of this clinical study.",[405,406],"Nasopharyngeal Carcinoma (NPC)","CTIT-Chemotherapy Induced Thrombocytopenia","2025-11-19",{"date":409,"type":34},"2025-11-26",{"date":411,"type":20},"2025-11-30",{"date":413,"type":20},"2028-11-30",{"name":40,"class":41},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":429,"leadSponsor":431,"locationsCount":4},"100611656","phase-2-hetrombopag-for-the-prevention-of-adc-induced-thrombocytopenia-in-breast-cancer-an-exploratory-dual-cohort-phase-2-study-100611656","NCT07243418","Hetrombopag for the Prevention of ADC-Induced Thrombocytopenia in Breast Cancer: An Exploratory, Dual-Cohort, Phase 2 Study","Dual-cohort, Single-arm, Exploratory Phase II Clinical Study of Hetrombopag for Primary\u002FSecondary Prevention of Thrombocytopenia Induced by ADC Drugs in Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age: 18 -75 years old, gender not limited.\n* 2\\. Breast cancer patients diagnosed by histopathological or cytological examination;\n* 3\\. Cohort 1: Planned to receive ADC drug treatment; Cohort 2: Patients who received ADC drug treatment in the previous chemotherapy cycle and had a minimum PLT value of less than 75\\*109\u002FL are expected to maintain the same chemotherapy regimen for ≥2 cycles.\n* 4\\. Expected survival period ≥12 weeks;\n* 5\\. Physical condition ECOG PS score: 0-2 points;\n* 6\\. The laboratory inspection indicators meet the following requirements:\n\n  1. Renal function: Cr≤UNL (upper limit of normal) ×1.5, endogenous creatinine clearance rate (Ccr) ≥55 ml\u002Fmin;\n  2. Liver function: Total bilirubin ≤ULN×1.5; ALT and AST≤ULN×3; If it is intrahepatic cholangiocarcinoma or liver metastasis, the total bilirubin shall not exceed three times the upper limit of normal, and the transaminase shall not exceed five times the upper limit of normal.\n  3. Coagulation function: The international normalized ratio of prothrombin time is ≤ULN×1.5, and some prothrombin times are within the normal range.\n* 7\\. Women of childbearing age agree to use contraception during the study period and for six months after the end of the study. And not a lactating patient; Male patients who agreed to contraception during the study period and for 6 months after the end of the study;\n* 8\\. Those who have not participated in other drug clinical trials within 4 weeks prior to enrollment;\n* 9\\. The subjects can understand the situation of this study and voluntarily sign the informed consent form.\n* 10\\. No serious complications such as active massive gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or non-cancerous fever \\> 38℃;\n* 11\\. Those with good expected compliance can follow up on the therapeutic effect and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* 1\\. Screening or baseline platelet value ≤10×109\u002FL;\n* 2\\. Patients who are currently taking pyrotinib, dalciclib or other CDK4\u002F6 class drugs\n* 3\\. Thrombocytopenia caused by non-tumor treatment occurred within 6 months before screening, including but not limited to liver cirrhosis with hypersplenism, infection and bleeding, etc.\n* 4\\. Suffering from other hematopoietic system diseases except for thrombocytopenia caused by anti-tumor therapy, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma and myelodysplastic syndrome, etc.\n* 5\\. Combined bone marrow invasion or bone marrow metastasis;\n* 6\\. Had received radiotherapy for the pelvis, spine and bone irradiation within 3 months before screening:\n* 7\\. Any history of arterial or venous thrombosis within 6 months prior to the screening;\n* 8\\. There were severe clinical manifestations of bleeding (such as gastrointestinal bleeding, etc.) within 2 weeks before screening;\n* 9\\. Patients with severe cardiovascular diseases (such as NYHA cardiac function score III-IV), arrhythmias known to increase the risk of thromboembolism such as atrial fibrillation, after coronary stent implantation, angioplasty, and after coronary artery bypass grafting within 6 months prior to screening;\n* 10\\. Brain tumors or brain metastases;\n* 11\\. When the absolute value of neutrophils is less than 1.0×109\u002FL and hemoglobin is less than 80g\u002FL, the use of granulocyte colony-stimulating factor and red blood cell, EPO infusion therapy that conforms to clinical routine is allowed.\n* 12\\. Significantly abnormal liver function: For patients without liver metastasis, ALT\u002FAST \\> 3ULN (upper limit of normal value), and TBIL \\> 3ULN; Patients with liver metastasis have ALT\u002FAST≥5ULN and TBIL≥5ULN.\n* 13\\. Abnormal renal function: Serum creatinine ≥1.5ULN or eGFR≤60 ml\u002Fmin (Cockcroft-Gault formula)\n* 14\\. Platelet transfusion was received within 2 days before enrollment;\n* 15\\. Received treatment with human recombinant thrombopoietin (rhTPO), human recombinant interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatracopag) within 10 days before screening;\n* 16\\. Patients who are known or expected to be allergic to or intolerant to the active ingredients or excipients of heltrombopag ethanolamine tablets (excipients include: cellulose-lactose, low-substitution hydroxypropyl cellulose, magnesium stearate, film-coated premixes);\n* 17\\. Pregnant or lactating women;\n* 18\\. Those who were considered unsuitable for inclusion by the researchers.",{"count":319,"type":20},[73],"The title of this study is: A two-cohort, single-arm, exploratory Phase II clinical study on the primary\u002Fsecondary prevention ADC drug of heltrombopag for thrombocytopenia caused by breast cancer. This study is a two-cohort, single-arm, open-label, exploratory clinical trial for the prevention of thrombocytopenia caused by ADC drug treatment for breast cancer. This research was supported by Fujian Cancer Hospital. The protocol has been reviewed by the Ethics Committee of Fujian Cancer Hospital, which has agreed to conduct this clinical study.",[406,170],{"date":427,"type":34},"2025-11-21",{"date":411,"type":20},{"date":430,"type":20},"2028-05-30",{"name":40,"class":41},{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":21,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":4},"100604869","phase-2-efficacy-and-safety-of-serplulimab-combined-with-etoposide-and-cisplatin-as-neoadjuvant-therapy-in-limited-stage-small-cell-carcinoma-of-the-esophageal-100604869","NCT07155122","Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal","Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal : A Single-Arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years;\n2. Histologically or cytologically confirmed diagnosis of SCCE prior to initiation of any treatment;\n3. Clinical stage cT2-4aNxM0 or cT1N+M0, corresponding to limited-stage SCCE based on the American Joint Committee on Cancer (AJCC) staging systemand the Veterans Administration Lung Study Group (VALSG) classification for small cell lung cancer;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n5. For women of childbearing potential, a negative serum or urine pregnancy test (minimum sensitivity of 25 IU\u002FL or equivalent) within 48 hours prior to the first administration of the study drug. Female patients must not be breastfeeding;\n6. All participants were required to undergo baseline laboratory evaluations within two weeks prior to treatment, and the results must meet the following criteria (based on CTCAE version 5.0):White blood cell count ≥ 3,000\u002FμL; Absolute neutrophil count ≥ 1,500\u002FμL; Platelet count ≥ 75 × 10³\u002FμL; Hemoglobin ≥ 9.0 g\u002FdL; Creatinine clearance \\> 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula); Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 × ULN; Total bilirubin ≤ 1.5 × ULN.\n7. Written informed consent must be obtained prior to the initiation of any study-related procedures. The informed consent form must be reviewed and approved by the institutional ethics committee. Participants must be willing and able to comply with the study protocol, including treatment, visit schedule, biospecimen collection, and other study-related requirements.\n\nExclusion Criteria:\n\n1. Patients with esophageal cancer of any histological type other than small cell carcinoma;\n2. Patients clinically staged as cT4bNanyM0, cTanyN3M0, or cTanyNanyM1;\n3. History of other malignancies, unless the patient has achieved complete remission for at least 3 years prior to enrollment and does not require or is not expected to require additional treatment during the study period;\n4. Known or suspected active autoimmune diseases. However, patients with type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may be included;\n5. Systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administration of study drugs. Inhaled, topical, or adrenal replacement corticosteroids at doses \\>10 mg\u002Fday of prednisone equivalent are permitted in the absence of active autoimmune disease;\n6. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or any other agents targeting T-cell co-stimulatory or immune checkpoint pathways;\n7. Any serious or uncontrolled medical conditions or active infections that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the patient's ability to receive the planned treatment;\n8. Known history of HIV infection or acquired immunodeficiency syndrome (AIDS). (Note: HIV testing must be performed at study centers where required by local regulations);\n9. Clinically significant arrhythmias, myocardial ischemia, severe atrioventricular block, heart failure, or significant valvular heart disease; severe pulmonary dysfunction; hematologic, hepatic, or renal dysfunction precluding tolerance to chemoradiotherapy; severe bone marrow failure; or uncontrolled infections;\n10. Inability to comply with the study protocol and procedures;\n11. Known hypersensitivity to any component of the investigational agents used in this study.",{"count":440,"type":20},15,[73],"This study is a prospective, single-center, single-arm phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with etoposide and platinum-based chemotherapy as neoadjuvant treatment for patients with limited-stage small cell carcinoma of the esophagus (SCCE). The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), disease control rate (DCR), disease-free survival (DFS), overall survival (OS) and safety. A total of 15 patients are expected to be enrolled.",[444],"Small-Cell Carcinoma of the Esophageal",[446,447,448],"Small Cell Carcinoma of the Esophagus","Neoadjuvant Therapy","Serplulimab","2025-09-07",{"date":451,"type":34},"2025-09-12",{"date":453,"type":20},"2025-09-01",{"date":455,"type":20},"2030-09-01",{"name":40,"class":41},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":237,"enrollmentInfo":465,"targetDuration":4,"studyType":21,"phases":467,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":42},"100597200","phase-2-neoadjuvant-iparomlimab-and-tuvonralimab-plus-chemotherapy-eclipse-for-locally-advanced-cervical-cancer-nice-cc-100597200","NCT07055399","Neoadjuvant Iparomlimab and Tuvonralimab Plus Chemotherapy-eclipse for Locally Advanced Cervical Cancer (NICE-CC)","Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Chemotherapy-eclipse for Locally Advanced Cervical Cancer：A Single-arm, Open-label, Phase II Trial","NICE-CC","Inclusion Criteria:\n\n* 1、Written informed consent\n* 2、18-70 years old\n* 3、Adequate organ function and ECOG of 0 \\~1\n* 4、Without systemic therapy at the time of enrollment\n* 5、FIGO 2018 stage IB3, IIA2, or IIIC1r\n* 6、Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix\n* 7、Measurable lesions could be defined by RECIST v1.1\n* 8、Willing to get blood\u002F tumor tissue tested\n* 9、Patients who observed the rules about the scheduled visit, study schedule, and medical examination\n* 10、The function of major organs is normal, and the following criteria are met:\n* 10.1 Blood routine examination must meet: (no blood transfusion within 14 days)\n\nHb≥90g\u002FL:\n\nANC≥1.5x10\\^9\u002FL; PLT≥100x10\\^9\u002FL;\n\n* 10.2 The biochemical examination must meet the following standards BIL \\\u003C 1.5 × ULN; ALT and AST \\\u003C 2.5xULN; ALB≥ 28 g\u002FL\n* 11、Patients who are willing and able to comply with visiting arrangements, treatment plans, laboratory tests, and other research procedures.\n\nExclusion Criteria:\n\n* 1、History of other malignancies within 3 years\n* 2、Participate in other clinical trials at the same time\n* 3、Active autoimmune disease, which needs systemic therapy\n* 4、Uncontrolled infection, which needs systemic therapy\n* 5、History of allogeneic tissue\u002Fsolid organ transplant\n* 6、Serious illness, such as severe mental disorders, cardiac disease, coagulation disorders, digestive system disease, etc\n* 7、Active HBV, HCV, or HIV infection\n* 8、Pregnant or lactating female patients\n* 9、Drug or alcohol abuse\n* 10、 Unable or unwilling to sign the informed consent",{"count":466,"type":20},43,[73],"Locally advanced cervical cancer (LACC) remains a significant global health concern with limited treatment options. Recent advancements suggest that using neoadjuvant anti-PD-1 inhibitors in combination with chemotherapy, followed by radical surgery, may be an effective treatment strategy for patients with PD-L1-positive LACC. This study aims to evaluate the efficacy and safety of preoperative treatment with iparomlimab and tuvonralimab-a bifunctional PD-1\u002FCTLA-4 dual blocker-combined with chemotherapy for LACC.",[470],"Locally Advanced Cervical Cancer",[104,472,473,474],"neoadjuvant","chemo-immunotherapy","iparomlimab and tuvonralimab;","2025-09-05",{"date":477,"type":34},"2025-09-11",{"date":479,"type":34},"2025-08-21",{"date":481,"type":20},"2029-09-01",{"name":40,"class":41},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":490,"targetDuration":4,"studyType":21,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":42},"100603869","safety-comparison-of-total-laparoscopic-proximal-gastrectomy-with-or-without-preservation-of-the-celiac-branch-of-the-vagus-nerve-for-early-upper-gastric-cancer-a-randomized-controlled-clinical-trial-100603869","NCT07142122","Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the Celiac Branch of the Vagus Nerve for Early Upper Gastric Cancer: A Randomized Controlled Clinical Trial","TLPG-CBVP","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).\n3. Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.\n4. Clinical stage cT1bN0M0 without lymph node metastasis.\n5. BMI \\\u003C30 kg\u002Fm².\n6. No history of upper abdominal surgery (except laparoscopic cholecystectomy).\n7. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy.\n8. ECOG performance status 0-1.\n9. ASA class I-III.\n10. Adequate organ function.\n11. Signed informed consent.\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding.\n2. Other malignancies within 5 years.\n3. Active infection requiring systemic therapy or fever ≥38°C preoperatively.\n4. Severe psychiatric illness.\n5. Severe respiratory disease.\n6. Severe hepatic or renal dysfunction.\n7. Unstable angina or myocardial infarction within 6 months.\n8. Stroke or intracranial hemorrhage within 6 months.\n9. Long-term systemic glucocorticoid therapy within 1 month (local use excluded).\n10. Complications of gastric cancer (bleeding, perforation, obstruction).\n11. Participation in another clinical study within 6 months.\n\nExclusion During Study (Removal Criteria):\n\nR0 resection not achieved, change of procedure to total gastrectomy or PPG, combined surgery for other diseases, severe perioperative complications, emergency surgery required, patient withdrawal of consent, or protocol violation.",{"count":491,"type":20},76,[23],"This prospective, single-center, randomized, controlled, non-inferiority clinical trial aims to compare the safety and postoperative quality of life of early upper gastric cancer patients undergoing total laparoscopic proximal gastrectomy (TLPG) with preservation of both the hepatic and celiac branches of the vagus nerve versus preservation of the hepatic branch only. The primary endpoint is gastric emptying half-time of solid food at 6 months after surgery. Secondary outcomes include incidence of reflux esophagitis, quality of life scores (EORTC QLQ-C30\u002FSTO22), number and positivity rate of lymph nodes retrieved, and 3-year disease-free survival. The study will provide evidence for optimizing minimally invasive surgical strategies for early upper gastric cancer.",[495],"Gastric Cancer",[497],"Esophagogastric Junction Adenocarcinoma","2025-08-25",{"date":500,"type":34},"2025-08-26",{"date":502,"type":34},"2025-01-01",{"date":504,"type":20},"2029-01-01",{"name":40,"class":41},{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":21,"phases":515,"briefSummary":516,"conditions":517,"keywords":521,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":4},"100600720","phase-2-dalpiciclib-as-adjuvant-therapy-for-hr-positiveher2-negative-early-stage-patients-100600720","NCT07101159","Dalpiciclib as Adjuvant Therapy for HR-positive\u002FHER2-negative Early-stage Patients","Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy in Early-stage HR-positive\u002FHER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study","Inclusion Criteria:\n\n* Female breast cancer patients aged ≥ 18 years, who are postmenopausal or premenopausal\u002Fperimenopausal;\n* Histologically confirmed HR-positive, HER2-negative early-stage breast cancer (immunohistochemical detection shows ER ≥ 10% and\u002For PR ≥ 10%, HER2 0-1+ or HER2 ++ but negative and non-amplified by FISH or CISH detection);\n* Histologically confirmed invasive breast cancer with postoperative pathological stage II-III;\n* Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy are eligible for enrollment;\n* The maximum time from surgery to enrollment does not exceed 12 months;\n* Patients receiving radiotherapy must have recovered from acute radiation reactions, with a washout period of at least 14 days from the end of radiotherapy to enrollment;\n* Patients who received previous chemotherapy must have recovered from acute adverse reactions of chemotherapy (graded ≤ 1 according to \\[CTCAE\\]) before enrollment, except for alopecia or grade 2 peripheral neuropathy. There must be a washout period of at least 21 days from the last chemotherapy administration to enrollment;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* The main organ function levels must meet the following requirements: Blood routine: Neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; Platelet count (PLT) ≥ 90×10⁹\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL;Blood biochemistry: Total bilirubin (TBIL) ≤ 2.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5×ULN; Alkaline phosphatase ≤ 2.5×ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5×ULN;\n* 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C 470 ms in females (QTcF calculation formula: QTcF = QT\u002F(RR\\^1\u002F3));\n* Voluntarily participate in this study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Stage IV breast cancer, recurrent or metastatic breast cancer, or inflammatory breast cancer;\n* A history of any malignant tumor, or having received anti-tumor treatment or radiotherapy for any malignant tumor in the past, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;\n* Concurrent participation in other clinical trials;\n* Having received blood transfusion or treatment with colony-stimulating factors, etc. within 2 weeks before enrollment;\n* Known history of allergy to the components of the drugs in this protocol;\n* History of immunodeficiency, including positive HIV test, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;\n* A history of any heart disease, including: angina pectoris; arrhythmia requiring drug treatment or with clinical significance; myocardial infarction; heart failure; any other heart disease judged by the researcher as unsuitable for participating in this trial;\n* Pregnant or lactating female patients;\n* Any other conditions that the researcher deems make the subject unsuitable for participating in this study.",{"count":514,"type":20},200,[73],"This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.\n\nIt is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.\n\nThe primary endpoint is 3-year invasive disease-free survival (iDFS).",[518,519,520],"Early Breast Cancer","Adjuvant Therapy","Hormone Receptor Positive \u002F HER2-negative Breast Cancer",[522,523,524],"dalpiciclib","hormone receptor positive\u002FHER2-negative breast cancer","early breast cancer","2025-08-01",{"date":527,"type":34},"2025-08-03",{"date":529,"type":20},"2025-09",{"date":531,"type":20},"2031-12",{"name":40,"class":41},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":240,"phases":4,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":551,"leadSponsor":552,"locationsCount":4},"100599745","watch-and-wait-after-immunochemotherapy-in-locally-recurrent-nasopharyngeal-carcinoma-100599745","NCT07088484","Watch-and-Wait After Immunochemotherapy in Locally Recurrent Nasopharyngeal Carcinoma","Watch-and-Wait Strategy in Patients With Objective Response After Immuno-chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma: A Prospective Multicenter Observational Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of sex.\n2. Treatment-naïve patients with newly diagnosed metastatic nasopharyngeal carcinoma (NPC).\n3. Receiving immunotherapy. (or Treated with immunotherapy)\n4. At least one measurable tumor lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1.\n5. Adequate organ function.\n6. Signed and dated informed consent form indicating that the patient (or legally authorized representative) has been informed of all pertinent aspects of the study.\n7. Patients willing and able to comply with scheduled visits and study procedures.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis of nasopharyngeal carcinoma.\n2. Patients who have not received immunotherapy or chemotherapy. (Alternatively: No prior immunotherapy or chemotherapy.)\n3. History of another active malignancy within the past 5 years, except for malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival \\>90%) or malignancies treated with curative intent and with no evidence of disease (e.g., adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer treated with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).\n4. Lack of capacity to provide informed consent.",{"count":541,"type":20},50,"The purpose of this study is to compare chemotherapy plus immunotherapy with immunochemotherapy combined subsequent locoregional radiotherapy in recurrent nasopharyngeal carcinoma (NPC), in order to confirm the value of immunotherapy and chemotherapy in recurrent NPC patients.",[544],"Recurrent Nasopharyngeal Carcinoma",[546],"locally recurrent nasopharyngeal carcinoma, watch-and-wait strategy, immuno-chemotherapy, low-intensity maintenance treatment","2025-07-20",{"date":549,"type":34},"2025-07-28",{"date":525,"type":20},{"date":203,"type":20},{"name":40,"class":41},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":560,"targetDuration":4,"studyType":21,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":568,"leadSponsor":570,"locationsCount":4},"100596496","phase-2-tislelizumab-combined-with-chemotherapy-for-resectable-esophageal-squamous-cell-carcinoma-followed-by-crt-or-surgery-100596496","NCT07046221","Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery","Tislelizumab Combined With Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma Followed by CRT or Surgery: A Prospective, Open-label, Multicenter Clinical Study","Inclusion Criteria:\n\n* The subjects were included in this study and signed the informed consent form.\n* Male or female patients aged between 18 and 75 years old;\n* Patients diagnosed with esophageal squamous cell carcinoma by histopathology;\n* According to the 8th edition of the AJCC Esophageal cancer TNM staging system, it is located in cT2N+ or cT3-4aNanyM0 (confirmed by enhanced CT\u002FMRI of the chest and abdomen), and the lesion is located in the thoracic segment.\n* ECOG score: 0-1.\n* The main organs function normally, that is, they meet the following standards:\n\n  1. Blood routine (no blood transfusion was performed within 14 days before treatment, no granulocyte colony-stimulating factor \\[G-CSF\\] was used, and no other drugs were used for correction);\n\n     The absolute neutrophil count (ANC) was ≥1.5×109\u002FL;\n\n     Hemoglobin (HB) ≥9.0 g\u002FdL;\n\n     Platelet count (PLT) ≥100×109\u002FL;\n  2. Blood biochemistry\n\nCreatinine clearance rate ≥60 mL\u002Fmin;\n\nTotal bilirubin (TBIL) ≤ 1.5×ULN;\n\nAspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;\n\n* The expected survival period is ≥3 months;\n* Female subjects with reproductive capacity and male subjects whose partners are of childbearing age need to adopt a medically approved contraceptive measure during the study treatment period and for at least 3 months after the last treatment\n\nExclusion Criteria:\n\n* There are clinically uncontrolled pleural effusions, pericardial effusions or ascites that require repeated drainage or medical intervention (within 2 weeks before randomization);\n* It is known that there is intolerance or resistance to the chemotherapy specified in the trial protocol;\n* Have received any other ESCC anti-tumor treatments (e.g., targeted treatments for PD-1, PD-L1, PD-L2, or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor treatments);\n* Patients with active autoimmune diseases or a history of autoimmune diseases that may recur, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Have a history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis, acute lung diseases, etc.\n* Before enrollment, there was a severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibacterial, antifungal or antiviral treatment;\n* A known history of HIV infection;\n* Having suffered from other malignant tumors within the past five years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix);\n* Have received live vaccines within 28 days before enrollment;\n* Participated in other therapeutic clinical trials within 4 weeks;\n* Those that the researchers consider unsuitable for inclusion.\n* Distant metastasis exists (except for supraclavicular lymph nodes).",{"count":299,"type":20},[73],"To explore the non-inferiority of the 2y-OS rate of tislelizumab combined with chemotherapy after sequential CRT in the treatment of resectable esophageal squamous cell carcinoma compared with the surgical group",[564],"Esophagus Cancer","2025-07-16",{"date":547,"type":34},{"date":525,"type":20},{"date":569,"type":20},"2030-08-01",{"name":40,"class":41},""]