[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasm-recurrence-local\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasm-recurrence-local":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,59,97,124,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100630129","non-inferiority-study-comparing-salvage-pelvic-radiotherapy-in-25-fractions-625-gy25-versus-20-fractions-525-gy20-for-recurrent-prostate-cancer-after-surgery-100630129",false,"NCT07483658","Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy\u002F25) Versus 20 Fractions (52.5 Gy\u002F20) for Recurrent Prostate Cancer After Surgery.","Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45\u002F62.5 Gy in 25 Fractions vs. 43\u002F52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)","HYP-OP-RT","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma.\n* Prior radical prostatectomy with detectable PSA (≥0.2 ng\u002FmL).\n* No evidence of distant metastasis (confirmed via bone scan and CT\u002FMRI or TEP-PSMA if PSA is above 0.5 ng \u002Fml).\n* Patient with Nodal recurrence within the pelvis are eligible\n* ECOG performance status 0-2.\n* Age ≥ 18 years.\n* Adequate baseline renal, hepatic, and hematologic function.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* Macroscopic local relapse on imaging\n* Presence of metastatic disease.\n* Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.\n* Uncontrolled comorbidities affecting study participation.\n* Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).","MALE","18 Years",{"count":20,"type":21},434,"ESTIMATED","INTERVENTIONAL",[24],"NA","Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule.\n\nWhy is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.\n\nWhat is being compared?\n\nStandard treatment (Arm A):\n\n25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy\n\nShorter treatment (Arm B):\n\n20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy\n\nBoth groups may also receive hormone therapy (ADT) for 6-24 months.\n\nMain Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.\n\nOther Things to be Measured\n\nCancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)\n\nWho can join?\n\nMen who:\n\nHad prostate surgery Have a detectable PSA (≥0.2 ng\u002FmL) No distant metastasis Are in good general health (ECOG 0-2)\n\nHow long will the study last?\n\nAbout 12 years total:\n\n2 years to enroll patients 10 years of follow-up",[27,28,29,30,31,32],"Reccurent\u002FMetastatic Solid Tumor Disease","Prostate Cancer (Post Prostatectomy)","Prostate Cancer","Prostatic Neoplasms","Neoplasm Recurrence, Local","Biochemical Recurrence of Malignant Neoplasm of Prostate",[34,35,36,37,38,39,40,41,42,43,44,45],"Radiotherapy, Adjuvant","Radiotherapy, Intensity-Modulated","Radiotherapy, High-Dose Hypofractionated","Pelvic Radiotherapy","Androgen Deprivation Therapy","Randomized Controlled Trials","Noninferiority Trials","Quality of Life","Treatment Outcome","Gastrointestinal Diseases \u002F chemically induced","Urinary Tract Diseases \u002F chemically induced","Radiation Injuries","RECRUITING","2026-06-29",{"date":49,"type":50},"2026-07-01","ACTUAL",{"date":52,"type":50},"2026-05-13",{"date":54,"type":21},"2036-02",{"name":56,"class":57},"CHU de Quebec-Universite Laval","OTHER",4,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":66,"minAge":18,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100557009","phase-2-cadonilimab-with-chemoradiation-for-recurrent-and-oligometastatic-endometrial-carcinoma-100557009","NCT06532539","Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma","A Phase II, Single-arm, Multicenter Clinical Trial of Definitive Treatment With Cadonilimab, Paclitaxel, Cisplatin and Radiation for the Treatment of Locally Recurrent and Oligometastatic Endometrial Carcinoma","Inclusion Criteria:\n\n1. A written informed consent form must be signed before the implementation of any trial-related procedures.\n2. Female, aged 18 years or older and 80 years or younger.\n3. ECOG PS 0-1.\n4. Newly diagnosed with histologically or cytologically confirmed primary endometrioid adenocarcinoma, serous carcinoma, clear cell adenocarcinoma, undifferentiated carcinoma, mixed cell adenocarcinoma, mesonephric adenocarcinoma, mucinous carcinoma, intestinal-type mesonephric-like adenocarcinoma, and carcinosarcoma, meeting the clinical diagnostic criteria for endometrial cancer.\n5. Patients with locally recurrent or oligometastatic endometrial cancer after initial treatment. The number of recurrent and metastatic lesions is ≤5. Screening criteria for oligometastasis: lymph node metastases in the same region count as one metastatic lesion; liver metastases are limited to one; lung metastases are limited to three.\n6. At least one site suitable for radiotherapy (including the primary lesion), measurable, and meeting the RECIST v1.1 criteria for evaluable lesions.\n7. Tumor samples available for biomarker assessment.\n8. Expected survival time ≥6 months.\n9. Normal major organ function (within 7 days before enrollment), meeting the following criteria:\n\n(1) Hematology standards (without blood transfusion or hematopoietic growth factor treatment within 14 days before enrollment):\n\n1. Hemoglobin (HB) ≥80 g\u002FL;\n2. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n3. Platelet count (PLT) ≥50×10\\^9\u002FL; (2) No functional or organic diseases, meeting the following criteria:\n\na) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total serum bilirubin ≤1.5×ULN, alkaline phosphatase (ALP) ≤3×ULN, serum albumin ≥30 g\u002FL; b) Serum creatinine (Cr) ≤1.5×ULN; if serum creatinine is \\>1.5×ULN, creatinine clearance (CrCl) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); c) Prothrombin time (PT) prolongation ≤6 seconds, activated partial thromboplastin time (APTT) ≤1.5×ULN; d) Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, FT3 and FT4 levels should be considered; if FT3 and FT4 levels are normal, enrollment is allowed); f) Left ventricular ejection fraction (LVEF) \\>50%. 11. Before starting the first treatment, all reversible toxic reactions from previous anti-tumor treatments must have resolved to ≤ grade 1 (based on CTCAE v5.0), excluding any grade of alopecia and pigmentation, ≤ grade 2 peripheral sensory neuropathy, and other abnormalities considered by the investigator and\u002For sponsor to pose a benefit-risk balance favoring the subject receiving the study treatment.\n\n12\\. Non-surgically sterilized or childbearing potential female patients must use medically recognized contraception (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Non-surgically sterilized childbearing potential female patients must have a negative serum or urine HCG test within 7 days before enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Subjects with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved and does not require any intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible).\n2. Subjects currently using immunosuppressive agents or systemic, or absorbable local corticosteroid therapy to achieve immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) and continuing use within 2 weeks prior to enrollment.\n3. Known history of grade 3 or 4 immune-related adverse events associated with previous anti-tumor immunotherapy.\n4. Poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past six months; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\>450 ms (males); QTc \\>470 ms (females).\n5. Coagulation dysfunction (INR \\>1.5 or PT \\>16 s), bleeding tendency, or receiving thrombolytic or anticoagulant therapy.\n6. Subjects who have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy within 4 weeks (or 5 drug half-lives, whichever is longer) prior to the first dose of the study drug; subjects with adverse events from previous treatments (excluding alopecia) that have not recovered to ≤CTCAE grade 1.\n7. Subjects with clinically uncontrolled third-space effusion requiring puncture drainage or other local treatment prior to the first dose of the investigational drug.\n8. Subjects with significant hemoptysis within 2 months before randomization, or hemoptysis of at least half a teaspoon (2.5 ml) per day.\n9. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism).\n10. Subjects with active infection or unexplained fever \\>38.5°C during the screening period or prior to the first dose.\n11. Subjects with a history of or current evidence of lung fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function.\n12. Subjects with congenital or acquired immune deficiencies (e.g., HIV infection) or active hepatitis (hepatitis B reference: HBV DNA exceeding the upper limit of normal; hepatitis C reference: HCV viral load or RNA exceeding the upper limit of normal).\n13. Subjects who have used other investigational drugs or similar therapeutic agents within 4 weeks prior to the first dose or who have received radiotherapy or other local treatments within 2 weeks prior to the first dose and have not recovered from the adverse effects of such treatments.\n14. Subjects with a history of or concurrent other malignancies (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).\n15. Subjects who may receive other systemic anti-tumor therapies during the study period.\n16. Subjects who have received or are expected to receive live vaccines within 4 weeks prior to the first dose or during the study period.\n17. Subjects with other factors that may lead to forced termination of the study as judged by the investigator, such as severe diseases (including mental disorders) requiring combined treatment, severe laboratory abnormalities, and family or social factors that may affect the safety of the subject or the collection of data and samples.","FEMALE","80 Years",{"count":69,"type":21},30,[71],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are:\n\n1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?\n2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?\n\nParticipants will:\n\n* Receive cadonilimab, paclitaxel, cisplatin, and radiation therapy according to a specified protocol.\n* Visit the clinic for regular checkups and tests throughout the treatment period.\n* Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.\n* Provide hematologic and tissue samples to explore biomarkers.\n\nThis study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma, as well as identify biomarkers to better guide treatment strategies.",[74,31,75],"Endometrial Neoplasms","Neoplasm Metastasis",[77,78,79,80,81,82,83,84,85,42,86],"Immunotherapy","Cadonilimab","Paclitaxel","Cisplatin","Radiation Therapy","Combined Modality Therapy","Clinical Trials, Phase II as Topic","Progression-Free Survival","Biomarkers, Tumor","Safety","2026-04-21",{"date":89,"type":50},"2026-04-24",{"date":91,"type":50},"2024-06-13",{"date":93,"type":21},"2026-09",{"name":95,"class":57},"Shandong Cancer Hospital and Institute",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":104,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":96},"100586185","phase-1-dose-finding-study-of-zanzalintinib-with-pembrolizumab-and-cetuximab-in-head-and-neck-scc-100586185","NCT06912087","Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC","A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and\u002For Metastatic Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n* Histologically or cytologically confirmed recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC), which is considered incurable by local therapies.\n* Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible.\n* Age: Participants must be at least 18 years old.\n* ECOG Performance Status: Must be 0-1.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.\n* For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing.\n* Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R\u002FM disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy.\n* Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from any adverse events (AEs), including immune-related AEs from prior treatments.\n* Adequate organ and marrow function, including:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n* Platelets ≥ 100,000\u002Fmm3.\n* Hemoglobin ≥ 9 g\u002FdL.\n* Normal liver and kidney function.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Contraception: Sexually active fertile subjects must agree to use a highly effective method of contraception during the study and for 2 months after the last dose of cetuximab and 4 months after the last dose of pembrolizumab.\n\nExclusion Criteria:\n\n* Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors.\n* More than two prior lines of systemic therapy in the recurrent\u002Fmetastatic setting.\n* Relapsed disease within 3 months of definitive therapy.\n* Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment).\n* Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks.\n* Concomitant anticoagulation with oral anticoagulants or platelet inhibitors, unless on stable doses of acceptable anticoagulants.\n* Active infection requiring systemic treatment or significant cardiovascular, gastrointestinal, or other serious health issues that may affect study participation.\n* Known or suspected autoimmune disease, except for specific conditions like type I diabetes or controlled skin disorders.\n* Pregnancy or breastfeeding: Women must not be pregnant or breastfeeding at screening.\n* Other malignancies within the past 2 years (except for certain low-grade cancers like localized skin cancers).","ALL",{"count":106,"type":21},36,[108],"PHASE1","This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).",[111,112,31,75,113,114],"Head and Neck Neoplasms","Carcinoma, Squamous Cell","Recurrent Squamous Cell Carcinoma","Metastatic Squamous Cell Carcinoma","2025-12-01",{"date":117,"type":50},"2025-12-02",{"date":119,"type":50},"2025-09-29",{"date":121,"type":21},"2027-06-05",{"name":123,"class":57},"University of Chicago",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":66,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":96},"100588516","phase-2-iparomlimab-and-tuvonralimab-with-chemoradiation-for-the-treatment-of-locally-recurrent-and-oligometastatic-cervical-cancer-100588516","NCT06942416","Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer","Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin\u002FCarboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer","Inclusion Criteria:\n\n1. Signed written informed consent prior to any trial-related procedures;\n2. Female, aged ≥18 and ≤75 years;\n3. ECOG PS 0-1;\n4. Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria;\n5. Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph node metastases within the same region = 1 lesion;Liver metastases ≤1 lesion;Lung metastases ≤3 lesions\n6. At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1;\n7. Available tumor tissue sample for biomarker assessment;\n8. Expected survival ≥6 months;\n9. Normal organ function (within 7 days pre-enrollment):\n\n(1) Hematological criteria (no transfusion\u002Fgranulocyte\u002Fplatelet-stimulating drugs within 14 days):\n\n1. Hemoglobin (Hb) ≥80 g\u002FL\n2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n3. Platelets (PLT) ≥50×10⁹\u002FL (2) No functional organic disease:\n\na) ALT\u002FAST ≤2.5×ULN, total bilirubin ≤1.5×ULN, ALP ≤3×ULN, albumin ≥30 g\u002FL b) Serum Cr ≤1.5×ULN (if \\>1.5×ULN, CrCl ≥50 mL\u002Fmin by Cockcroft-Gault formula) c) PT prolongation ≤6 sec, APTT ≤1.5×ULN d) TSH ≤ULN (if abnormal, FT3\u002FFT4 must be normal) f) LVEF \\>50% 10. Prior anti-tumor treatment toxicities recovered to ≤Grade 1 (CTCAE v5.0) pre-treatment, excluding:\n\n* Alopecia\u002Fpigmentation (any grade)\n* Peripheral neuropathy (≤Grade 2)\n* Other toxicities where benefit-risk favors treatment 11. Non-sterilized\u002Fchildbearing-potential females must:\n* Use medical contraception (IUD\u002Foral contraceptives\u002Fcondoms) during treatment + 3 months post-treatment\n* Negative serum\u002Furine HCG within 7 days pre-enrollment\n* Non-lactating 12. Expected compliance with protocol follow-up following criteria:\n\n  1. Prior immunotherapy (e.g., immune checkpoint inhibitors);\n  2. Pathological diagnosis of gastric-type adenocarcinoma;\n  3. Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions: vitiligo; childhood asthma fully resolved without intervention in adulthood. Exclusion: asthma requiring bronchodilator therapy;\n  4. Current use of immunosuppressants or systemic\u002Fabsorbable topical corticosteroids (equivalent to \\>10 mg\u002Fday prednisone) for immunosuppression, continued within 2 weeks before enrollment;\n  5. History of Grade 3-4 immune-related adverse events (irAEs) associated with prior anti-tumor immunotherapy;\n  6. Poorly controlled cardiac conditions:\n\n  \u003C!-- -->\n\n  1. NYHA Class II or higher heart failure\n  2. Unstable angina\n  3. Myocardial infarction within 6 months\n  4. Clinically significant supraventricular\u002Fventricular arrhythmia requiring treatment\n  5. QTc \\>450 ms (males) or \\>470 ms (females); 7. Coagulation abnormalities (INR \\>1.5 or PT \\>16 s), bleeding tendency, or current thrombolytic\u002Fanticoagulant therapy; 8. Prior radiotherapy\u002Fchemotherapy\u002Fhormonal therapy\u002Fsurgery\u002Ftargeted therapy completed \\\u003C4 weeks before study treatment (or \\\u003C5 drug half-lives, whichever is longer); unresolved toxicities (excluding alopecia) from prior therapies \\>CTCAE Grade 1; 9. Poorly controlled third-space effusion requiring drainage before first trial drug administration; 10. Significant hemoptysis (≥2.5 mL\u002Fday) within 2 months before randomization; 11. Known hereditary\u002Facquired bleeding\u002Fthrombotic disorders (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism); 12. Active infection or unexplained fever \\>38.5°C during screening\u002Fbefore first dose; 13. Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction; 14. Immunodeficiency (e.g., HIV infection) or active hepatitis:\n\n     * HBV DNA \\> upper limit of normal (ULN)\n     * HCV RNA \\> ULN; 15. Use of other investigational drugs within 4 weeks before first dose; radiotherapy\u002Flocal therapy within 2 weeks without full recovery; 16. Concurrent\u002Fprior malignancies (except cured basal cell carcinoma\u002Fcervical carcinoma in situ); 17. Planned concurrent systemic anti-tumor therapy during the study; 18. Live vaccination within 4 weeks before treatment or planned during the study; 19. Other conditions potentially requiring study termination per investigator judgment:\n     * Severe comorbidities (including psychiatric disorders) requiring treatment\n     * Critical lab abnormalities\n     * Social\u002Ffamily factors compromising safety or data\u002Fsample collection.","75 Years",{"count":106,"type":21},[71],"The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin\u002Fcarboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are:\n\n1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?\n2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?\n\nParticipants will:\n\n* Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin\u002FCarboplatin and radiation therapy according to a specified protocol.\n* Visit the clinic for regular checkups and tests throughout the treatment period.\n* Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.\n* Provide hematologic、tissue and stool samples to explore biomarkers.\n\nThis study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.",[136,31,137],"Cervical Cancer","Oligometastatic",[77,79,80,139,81,83,84,85,42,86,140],"Carboplatin","Iparomlimab and Tuvonralimab","2025-04-16",{"date":143,"type":50},"2025-04-24",{"date":145,"type":50},"2025-02-28",{"date":147,"type":21},"2028-12-31",{"name":95,"class":57},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":104,"minAge":18,"maxAge":131,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":96},"100549980","phase-3-multicenter-clinical-trial-on-the-effectiveness-and-safety-of-instillation-of-bcg-and-alternative-bcg-protocols-for-intermediate-and-high-risk-non-muscle-invasive-bladder-cancer-100549980","NCT06441110","Multicenter Clinical Trial on the Effectiveness and Safety of Instillation of BCG and Alternative BCG Protocols for Intermediate and High-risk Non-muscle Invasive Bladder Cancer","Multicentre Clinical Trial of the Efficacy and Safety of Tislelizumab in Combination With BCG Bladder Instillation in the Prevention of Postoperative Recurrence in Intermediate and High-risk Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Voluntary participation in the trial with signed informed consent;\n2. Patients aged ≥18 and ≤75 years, regardless of gender, with an expected survival of ≥2 years;\n3. Histologically confirmed non-muscle-invasive bladder urothelial carcinoma with positive PD-L1 expression. According to the 2014 guidelines of the Chinese Urological Association (CUA), patients are assessed as having a medium to high risk of recurrence or progression. (For patients considering a second transurethral resection, they may be included in the study after completing the procedure and if pathology confirms medium to high risk non-muscle-invasive bladder urothelial carcinoma);\n4. Performance status score (Eastern Cooperative Oncology Group, ECOG) of 0-2;\n5. Completion of screening-related examinations (complete blood count, coagulation function, liver and kidney function, infectious disease screening, 12-lead ECG, urinary system ultrasound, pelvic MR, and tissue pathology examination), without surgical contraindications.\n\nExclusion Criteria:\n\n1. Any of the following conditions:\n\n   Immune deficiency or impairment (such as AIDS patients), current use of immunosuppressive drugs or radiation therapy that may cause systemic BCG disease reaction; allergy to BCG components; patients with fever and acute infectious diseases, including active tuberculosis or those undergoing anti-tuberculosis treatment; those with severe chronic cardiovascular or cerebrovascular diseases or chronic kidney disease;\n2. Concurrent urogenital system tumors or tumors in other organs;\n3. Muscle-invasive bladder urothelial carcinoma (stage T2 and above) patients;\n4. Patients who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except immediate postoperative bladder instillation chemotherapy);\n5. Pregnant or lactating women, women of childbearing age not using effective contraception, or those planning to conceive during the trial period (including male participant partners);\n6. Known or suspected intraoperative bladder perforation;\n7. Presence of gross hematuria prior to enrollment, suspected unhealed surgical wounds or damaged urinary mucosa;\n8. Severe urethral stricture preventing cystoscopy, history of bladder contracture, or functional bladder volume less than 100mL;\n9. Accompanying cystitis, or those who have received other bladder instillation medications and have severe bladder irritation signs expected to affect the assessment of this study;\n10. Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic function disorders, etc., that cannot tolerate surgical treatment;\n11. Participation in other drug clinical trials within 3 months before enrollment;\n12. Known or suspected opioid or alcohol dependence;\n13. Any condition that the researcher believes may increase the risk to the participant or interfere with the execution of the clinical trial.",{"count":157,"type":21},76,[159],"PHASE3","Previous studies have reported the efficacy of Bacillus Calmette-Guérin (BCG) combined with other drugs for the treatment of bladder cancer. However, research on the combination of tislelizumab and BCG for bladder cancer treatment has largely been retrospective. Currently, ongoing clinical trials have not discussed the effectiveness of PD-1\u002FPD-L1 inhibitors combined with BCG instillation in reducing postoperative recurrence in intermediate-risk NMIBC. Therefore, this study aims to explore the clinical efficacy and safety of tislelizumab combined with BCG in the treatment of intermediate and high-risk NMIBC. For this purpose, investigators have established strict screening criteria to include eligible patients in the study and have recruited suitable patients from multiple medical centers.Investigators have also developed a meticulous implementation process and follow-up considerations, hoping to better verify the clinical efficacy and safety of the combined use of these two drugs.",[162,163,164,165,42,31],"Urinary Bladder Neoplasms","BCG Vaccine","Immunotherapy, Active","Multicenter Study","2024-06-03",{"date":168,"type":50},"2024-06-04",{"date":170,"type":50},"2023-06-01",{"date":172,"type":21},"2035-06-01",{"name":174,"class":57},"Fujian Medical University Union Hospital"]