[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sintilimab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sintilimab":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,45,74,101,125,149,173,197,222],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100631855","phase-2-a-phase-ii-study-of-sintilimab-combined-with-ipilimumab-n01-cetuximab-and-dabrafenib-in-patients-with-microsatellite-stable-braf-v600e-mutated-metastatic-colorectal-cancer-100631855",false,"NCT07506109","A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Provided written informed consent.\n2. Age ≥ 18 years.\n3. Histologically or pathologically confirmed colorectal adenocarcinoma.\n4. Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.\n5. Locally advanced unresectable disease or distant metastasis.\n6. No prior treatment with BRAF\u002FMEK\u002FERK inhibitors, EGFR inhibitors, or immune checkpoint inhibitors (ICI).\n7. Presence of measurable target lesions per RECIST 1.1.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n9. Adequate organ function, based on the following laboratory values obtained within 7 days prior to Cycle 1 Day 1:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL.\n   2. Absolute neutrophil count ≥ 1,500\u002Fmm³ (≥ 1.5 × 109\u002FL).\n   3. Platelet count ≥ 80,000\u002Fmm³ (≥ 80 × 109\u002FL).\n   4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).\n   5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n   6. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin.\n10. Willing and able to comply with study procedures and visit schedule.\n\nExclusion Criteria:\n\n1. Received any approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment.\n2. Underwent any surgery or invasive procedure within 4 weeks prior to study initiation (exceptions include venous catheter placement and paracentesis\u002Fdrainage).\n3. Multiple primary malignancies (exceptions include completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or any other cancer that has been in complete remission for at least 3 years).\n4. Presence of severe comorbidities or serious medical conditions.\n5. Pregnant or breastfeeding females.\n6. The investigator deems the patient unsuitable for participation in this study.","ALL","18 Years",{"count":18,"type":19},49,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Colorectal cancer (CRC) is the second leading cause of cancer-related death globally. BRAF V600E mutations occur in approximately 12% of metastatic CRC (mCRC) patients, conferring an extremely poor prognosis with a median overall survival (OS) of only 11 months for standard chemotherapy. Most BRAF V600E-mutant mCRC are microsatellite stable (MSS) and do not benefit from single-agent PD-1\u002FPD-L1 inhibition.\n\nPreclinical and clinical evidence indicates that BRAF inhibition in combination with EGFR blockade can induce DNA damage, trigger a deficient mismatch repair (dMMR) phenotype, and increase tumor mutational burden (TMB), thereby sensitizing MSS tumors to immune checkpoint inhibition. This provides a strong rationale for combining BRAF\u002FEGFR inhibitors with anti-PD-1 and anti-CTLA-4 immunotherapy.\n\nThis is a single-arm, open-label, Phase II clinical trial. The primary objective is to evaluate the efficacy and safety of the triplet combination of sintilimab (anti-PD-1), ipilimumab N01 (anti-CTLA-4), cetuximab (anti-EGFR), and dabrafenib (BRAF inhibitor) in patients with MSS, BRAF V600E-mutant mCRC.",[25,26,27,28,29,30,31],"BRAF V600E","Colorectal Cancer","Sintilimab","MSS (Microsatellite Stable)","Cetuximab","Dabrafenib","Ipilimumab N01","RECRUITING","2026-04-01",{"date":35,"type":36},"2026-04-07","ACTUAL",{"date":38,"type":36},"2026-03-01",{"date":40,"type":19},"2028-06",{"name":42,"class":43},"Tianjin Medical University Cancer Institute and Hospital","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100603610","phase-2-the-efficacy-and-safety-of-the-combination-of-pd-1-with-chemotherapy-and-adaptive-radiotherapy-strategy-in-the-treatment-of-stage-iii-non-small-cell-lung-cancer-patients-100603610","NCT07138755","The Efficacy and Safety of the Combination of PD-1 With Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients","The Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n1. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study\n2. Age range of 18-75 years old upon enrollment, both male and female are eligible\n3. Stage III NSCLC confirmed by histology or cytology (according to the International Union Against Cancer and the Joint American Committee on Cancer 8th edition TNM staging of lung cancer)\n4. It was clarified that surgical resection is not possible After MDT discussion,\n5. The main driver genes have no sensitive mutations (including EGFR, ALK, ROS1, MET, HER2, etc.)\n6. No previous systematic anti-tumor treatment or chest radiotherapy for NSCLC\n7. According to RECIST v1.1, there is at least one measurable lesion, and according to RECIST v1.1, this lesion is suitable for repeated and accurate measurements\n8. There is sufficient organ function reserve to meet the needs of clinical research\n\nExclusion Criteria:\n\n1. There are any small cell carcinoma components present in the histopathology, as well as special types such as salivary gland type and SMARCA4 deficiency\n2. Except for NSCLC, the subjects had other malignant tumors within the 5 years prior to enrollment. Subjects with other tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ, are not excluded\n3. Previously received local treatments for tumor lesions such as thoracic radiotherapy and radiofrequency ablation\n4. Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 1 week before the first administration\n5. Suffering from active autoimmune diseases that require systematic treatment within the past two years\n6. History of immunodeficiency; Individuals who test positive for HIV antibodies; Currently in long-term use of systemic corticosteroids or other immunosuppressants\n7. Subjects who are known to have active pulmonary tuberculosis (TB) and suspected of having TB need to undergo clinical examination to exclude them; Known active syphilis infection\n8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n9. Previous or current non infectious pneumonia\u002Finterstitial lung disease requiring systemic corticosteroid therapy\n10. Serious infection occurred within 4 weeks prior to the first administration, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received systemic anti infective therapy within 2 weeks prior to the first administration (excluding antiviral therapy for hepatitis B or C)\n11. Current active hepatitis B subjects (HBsAg positive and HBV-DNA exceeding 1000 copies\u002Fml (200IU\u002Fml) or above the detection limit)\n12. Tumor invasion or compression of important surrounding organs (such as aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.) or the risk of developing esophagotracheal fistula or esophageal pleural fistula; Tumor mediastinal lymph node metastasis invading the trachea and main bronchus with the risk of bronchial fistula\n13. History of myocarditis, cardiomyopathy, and malignant arrhythmia in the past\n14. Within 6 months prior to the first administration, there is a history of esophageal and gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding\n15. Any arterial thromboembolic event, NCI CTCAE 5.0 grade 3 or higher venous thromboembolic event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred within 6 months prior to the first administration; Currently, there is hypertension and after treatment with oral antihypertensive drugs, the systolic blood pressure is ≥ 160mmHg or the diastolic blood pressure is ≥ 100mmHg\n16. History of severe bleeding tendency or coagulation dysfunction\n17. Received a live vaccine within 30 days prior to the first administration, or planned to receive a live vaccine during the study period\n18. Known to be allergic to any component of any anti-tumor drug; Known history of severe hypersensitivity reactions to other monoclonal antibodies\n19. Known history of mental illness, drug abuse, alcoholism, or drug use\n20. Pregnant or lactating women\n21. Any past or current diseases, treatments, or laboratory abnormalities that may confuse the research results, affect the participants' full participation in the study, or may not be in the best interests of the participants\n22. Local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risks and\u002For uncertainty in survival evaluation, such as tumor like leukemia reactions (white blood cell count\\>20 × 109\u002FL), cachexia manifestations (such as known weight loss of more than 10% in the first 3 months of screening), etc","75 Years",{"count":54,"type":19},35,[22],"To evaluate the Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients",[58,27,59],"NSCLC","Adaptive Radiotherapy",[61,62,59,63],"V20","stage III NSCLC","sintilimab","2026-03-20",{"date":66,"type":36},"2026-03-25",{"date":68,"type":36},"2025-08-29",{"date":70,"type":19},"2030-09",{"name":72,"class":43},"The Third Xiangya Hospital of Central South University",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":20,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":73},"100624996","phase-2-thiotepa-in-combination-with-pirtobrutinib-a-btk-inhibitor-and-sintilimab-a-pd-1-inhibitor-for-frail-or-relapsedrefractory-primary-or-secondary-central-nervous-system-lymphoma-100624996","NCT07416890","Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","A Prospective, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Histopathologically confirmed relapsed primary central nervous system lymphoma (PCNSL) of B-cell lineage, or secondary central nervous system lymphoma (SCNSL) with a previously confirmed B-cell origin primary lesion but without evidence of active extracranial systemic involvement.\n2. The patients or their legal guardians provide voluntary written informed consent.\n3. Age\\>=18 years, both male and female.\n4. Karnofsky Performance Status (KPS) score\\>=40.\n5. Patients deemed unsuitable for methotrexate (MTX)-based systemic chemotherapy (\"unfit\"), including but not limited to: patients assessed as unsuitable for chemotherapy or frail according to a simplified Geriatric Assessment (sGA) criteria; patients with contraindications to MTX (e.g., renal insufficiency, serous cavity effusions, oral mucositis, etc.); or patients who refuse high-dose methotrexate (HD-MTX) chemotherapy.\n6. Life expectancy of greater than 3 months, as judged by the investigator.\n7. Patients with parenchymal lesions (\\>10\\*10mm ) on contrast-enhanced cranial MRI or those with leptomeningeal disease only, require cytological examination of cerebrospinal fluid (CSF) to confirm the presence of lymphoma cells and\u002For imaging findings consistent with CSF results. These assessments must be completed within 14 days prior to enrollment.\n8. If the patients have received prior anti-tumor therapy, all treatment-related non-hematologic toxicities must have recovered to Grade 1 or baseline (according to NCI CTCAE version 5.0, with the exception of alopecia).\n9. Bone marrow and organ function must meet the following criteria (without transfusion, G-CSF support, or corrective therapy within 14 days prior to informed consent):\n\n   1. Hematological: Absolute neutrophil count (ANC) \\>=1.5\\*10\\^9\u002FL (1500\u002Fmm\\^3), platelets \\>=75\\*10\\^9\u002FL, hemoglobin\\>=8 g\u002FdL (If bone marrow is involved, then platelets\\>=50\\*10\\^9\u002FL, ANC \\>=1.0\\*10\\^9\u002FL, and hemoglobin\\>=7 g\u002FdL are acceptable).\n   2. Hepatic: Total bilirubin \\\u003C=1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=2.5 × ULN.\n   3. Renal: Serum creatinine \\\u003C=1.5 × ULN or estimated creatinine clearance \\>=60 mL\u002Fmin.\n   4. Coagulation: INR \\\u003C=1.5 × ULN; PT and APTT \\\u003C=1.5 × ULN (unless the subject is receiving anticoagulant therapy and, at screening, PT and APTT are within the anticipated therapeutic range for the anticoagulant regimen).\n10. For the subjects of reproductive age women and fertile men, during the entire study period and within 3 months after the interruption of treatment, they must not have any conception plans with their partners. During the entire study period and within 3 months after the interruption of treatment, one of the following measures must be taken for effective contraception: abstinence, physical contraception (such as sterilization or condoms), and the use of hormonal contraceptive drugs (w hich must start at least 3 months before the first administration upon enrollment). For male subjects, sperm donation is prohibited from the start of treatment until 3 months after the cessation of treatment.\n11. Willingness and ability to undergo multiple MRI\u002FCT scans and an expected ability to undergo lumbar puncture.\n\nAbility to swallow oral medication without difficulty.\n\nExclusion Criteria:\n\n1. The patients with secondary central nervous system lymphoma (SCNSL) who have lesions outside the CNS and require systemic treatment.\n2. Received chemotherapy, radiotherapy, immunotherapy or antibody-based treatments for anti-tumor purposes within 4 weeks prior to the first administration (or within 5 half-lives), those who had used small molecule targeted drugs or traditional Chinese medicine with anti-tumor indications within 2 weeks, and those who had received monoclonal antibody conjugate drug treatments within 10 weeks.\n3. Receipt of any vaccine (including but not limited to vaccines for COVID-19, influenza, pneumonia, shingles, hepatitis B, etc.) within 4 weeks before taking the medicine for the first time.\n4. Concurrent enrollment in another interventional clinical study, or less than 4 weeks between the last dose of prior clinical trial treatment and the first dose in this study.\n5. Previous treatment with thiotepa, PD-1 inhibitors, or BTK inhibitors is not excluded by default but requires benefit-risk assessment by the investigator. Subjects with a history of Grade \\>=3 immune-related adverse events (per NCI CTCAE v5.0) attributed to these agents are excluded.\n6. History of active bleeding within 4 weeks before the first dose; need for therapeutic anticoagulation during the study (e.g., warfarin or vitamin K antagonists); or any condition associated with elevated bleeding risk or coagulopathy per investigator judgment (e.g., high-risk esophageal varices, active ulcer disease).\n7. Treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers is required within 2 weeks before the first administration or during the study period.\n8. Concurrent presence of other malignant tumors requiring antineoplastic treatment.\n9. Having uncontrolled or significant cardiovascular diseases, including (but not limited to):\n\n   1. Any of the following conditions occurring within 6 months before the first administration: congestive heart failure with New York Heart Association class \\>= 3, myocardial infarction, unstable angina pectoris, arrhythmia requiring treatment at screening, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);\n   3. A history of clinically significant QTc interval prolongation, second-degree type II atrioventricular block, third-degree atrioventricular block, or a QTc interval \\> 470ms (for females) and \\> 450ms (for males);\n   4. Atrial fibrillation (EHRA class\\>= 2b);\n   5. Poorly controlled hypertension, which is deemed unsuitable for study participation by the investigator.\n10. Active uncontrolled infection requiring intravenous antimicrobial treatment.\n11. Patients with active chronic hepatitis B, active chronic hepatitis C, or syphilis. Patients who test positive for hepatitis B surface antigen or hepatitis C virus antibody during the screening period must undergo further tests for HBV DNA titer (which must not exceed 1000 IU\u002Fml) and HCV RNA (which must not exceed the lower detection limit of the assay) before being eligible for enrollment in the trial. Hepatitis B virus carriers, patients with hepatitis B stabilized after drug treatment, and patients with cured hepatitis C may be enrolled.\n12. Patients with a known history of HIV infection and\u002For AIDS.\n13. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or total gastrectomy.\n14. Autologous transplantation within 3 months, or organ or allogeneic stem cell transplantation within 6 months, before signing the informed consent form.\n15. Pregnancy or lactation.\n16. Stroke or intracranial hemorrhage within 6 months before first dosing, excluding post-surgical sequelae of intracranial bleeding.\n17. History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or similar conditions, deemed by the researcher as rendering the subject unsuitable for participation in the trial.\n18. Participants whom the investigator considers unsuitable for the study due to existing kidney, nerve\u002Fmental, liver, or endocrine diseases, or for any other reason judged by the researcher.\n19. Exclude patients with active autoimmune disease or a history of it, including but not limited to: immune-related neurologic disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, SLE, connective-tissue disease, scleroderma, inflammatory bowel disease (Crohn's or ulcerative colitis), hepatitis, TEN, Stevens-Johnson syndrome, antiphospholipid syndrome.\n\n    Note: allow subjects with vitiligo, eczema, type 1 diabetes, or endocrine disorders (e.g., thyroiditis on physiologic steroid replacement). Subjects with rheumatoid arthritis\u002Fother arthropathies, Sjögren's syndrome, controlled celiac disease, or psoriasis treated only topically, and those seropositive (ANA, anti-thyroid antibodies, etc.) must be assessed for target-organ involvement and need for systemic therapy; if neither is present, they may be enrolled.\n20. Major surgery within 28 days prior to the first study dose, as determined by the investigator.","80 Years",{"count":83,"type":19},24,[22],"This is a prospective, single-Arm, phase II clinical study evaluating the efficacy and safety of thiotepa in combination with pirtobrutinib (a BTK Inhibitor) and sintilimab (a PD-1 Inhibitor) for frail or relapsed\u002Frefractory primary or secondary central nervous system lymphoma.It includes screening phase， induction therapy phase, and maintenance therapy phase.The screening period is defined as within 14 days prior to the first dose.Induction Treatment Phase: Enrolled subjects will receive a combination regimen of thiotepa, pirtobrutinib, and sintilimab. Treatment is administered in 21-day cycles for up to 6 cycles. Patients who achieve a disease response may proceed to consolidation therapy with either autologous hematopoietic stem cell transplantation or whole-brain radiotherapy at the investigator's discretion.Maintenance Treatment Phase: For patients who do not receive consolidation therapy with autologous transplantation or whole-brain radiotherapy, maintenance treatment with pirtobrutinib plus sintilimab will be initiated (for up to 1 year). Patients who receive any consolidation therapy will not proceed to maintenance treatment.Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria. The trial will monitor patient survival data, objective response rate (ORR), and safety parameters.Upon discontinuation of study treatment or completion of the 1-year treatment period, subjects will enter the follow-up phase. During follow-up, radiographic assessments (contrast-enhanced CT of the involved site is recommended) will be performed according to the following schedule: every 3 months for the first 2 years, every 6 months from Year 3 to Year 5, and annually after 5 years, until the end of the follow-up period. For subjects who have not withdrawn consent, survival information (including date and cause of death, subsequent anti-tumor therapies, etc.) will be collected every 3 months via telephone and\u002For clinical visit.",[87,27,88],"Pirtobrutinib","Central Nervous System Lymphoma",[90,63,91],"pirtobrutinib","central nervous system lymphoma","2026-02-11",{"date":94,"type":36},"2026-02-18",{"date":96,"type":19},"2026-02-10",{"date":98,"type":19},"2030-08-05",{"name":100,"class":43},"Zhejiang Cancer Hospital",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":20,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":73},"100617915","phase-2-sintilimab-plus-bevacizumab-biosimilar-as-neoadjuvant-therapy-for-resectable-hepatocellular-carcinoma-100617915","NCT07324824","Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma","Sintilimab Combined With Bevacizumab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: A Single-Arm, Prospective Phase II Study","Inclusion Criteria:\n\n1. Able to provide informed consent and willing to sign an approved consent form;\n2. Aged ≥ 18 years;\n3. Clinically diagnosed or pathologically confirmed resectable hepatocellular carcinoma beyond the Milan criteria (CNLC Ib-IIa);\n4. No prior anti-HCC treatment;\n5. Child-Pugh class A.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n7. Expected survival time of \\> 6 months.\n8. Sufficient organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Known as cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and hepatic fibrolamellar carcinoma;\n2. History of organ transplantation or hepatic encephalopathy\n3. Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage\n4. History of esophageal or gastric variceal bleeding caused by portal hypertension within the past 6 months; Documented severe (Grade 3) varices identified by endoscopy within 3 months prior to enrollment; Evidence of portal hypertension and assessed by the investigator as being at high risk of bleeding.\n5. Arterial and venous thromboembolic events in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism history;\n6. Any life-threatening bleeding event occurring within the past 3 months;\n7. Severe bleeding tendency, coagulopathy, or ongoing thrombolytic therapy.\n8. Chronic requirement for medications that inhibit platelet function, such as aspirin (\\>325 mg\u002Fday), dipyridamole, or clopidogrel.\n9. Uncontrolled hypertension, defined as systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg despite optimal medical management; history of hypertensive crisis or hypertensive encephalopathy.\n10. Symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Functional Class II-IV); symptomatic or poorly controlled arrhythmias; history of congenital long QT syndrome; or corrected QT interval (QTc) \\>500 ms at screening (calculated using Fridericia's formula).\n11. History of gastrointestinal perforation and\u002For fistula, intestinal obstruction (including incomplete obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic persistent diarrhea within the past 6 months.\n12. Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to enrollment; presence of unhealed wounds, ulcers, or fractures; or tissue biopsy or other minor surgical procedure within 7 days prior to enrollment, excluding venous catheterization for intravenous infusion.\n13. Past or current history of pulmonary diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impairment of lung function.\n14. Active acute or chronic hepatitis B or C infection, defined as: hepatitis B virus (HBV) DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL; hepatitis C virus (HCV) RNA \\>10³ copies\u002FmL; or concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies.\n15. Active tuberculosis (TB); ongoing anti-TB treatment; or anti-TB treatment completed within 1 year prior to the initiation of study treatment.\n16. Human immunodeficiency virus (HIV) infection (positive for HIV 1\u002F2 antibodies); known syphilis infection.\n17. Severe active infection or infection with poor clinical control.\n18. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to enrollment. Substitution therapy (e.g., thyroid hormone, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) is permitted. A history of known primary immunodeficiency is excluded. Patients with isolated positive autoimmune antibodies must be evaluated by the investigator to confirm the absence of underlying autoimmune disease.\n19. Use of immunosuppressive drugs within 4 weeks prior to enrollment, excluding intranasal, inhaled, or other topical corticosteroids, or systemic corticosteroids at physiological doses (i.e., ≤10 mg\u002Fday of prednisone or equivalent). Temporary use of corticosteroids for the management of dyspnea related to asthma, chronic obstructive pulmonary disease (COPD), or other conditions is permitted.\n20. Administration of live-attenuated vaccines within 4 weeks prior to enrollment or planned administration of live-attenuated vaccines during the study period.\n21. Use of immunomodulatory agents (including thymosin, interferons, or interleukins) within 2 weeks prior to enrollment, excluding local administration for the control of pleural effusion or ascites.\n22. Uncontrolled\u002Funcorrectable metabolic disorders, other non-malignant organ\u002Fsystemic diseases, or cancer-related sequelae that pose a high medical risk and\u002For introduce uncertainty in survival assessment.\n23. Diagnosis of other malignant tumors within 5 years prior to enrollment, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For curatively resected carcinoma in situ. For malignant tumors diagnosed more than 5 years prior to drug administration, pathological or cytological confirmation of recurrent or metastatic lesions is required.\n24. Prior receipt of any anti-angiogenic agents, anti-PD-1 antibodies, anti-PD-L1\u002FL2 antibodies, anti-CTLA-4 antibodies, or other immunotherapies.\n25. Known hypersensitivity to sintilimab, bevacizumab formulations, or their excipients; or history of severe hypersensitivity reactions to other monoclonal antibodies.\n26. Receipt of treatment in other clinical trials within 4 weeks prior to enrollment.\n27. Pregnant or breastfeeding female patients.\n28. Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory findings that, in the investigator's judgment, would: increase the risk associated with study participation or study drug administration; interfere with the interpretation of study results; or render the patient ineligible for study participation.",{"count":109,"type":19},37,[22],"Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Nevertheless, there is no standard neoadjuvant treatment regimen for HCC to date. In recent years, targeted therapy and immunotherapy are proved to improve the prognosis of advanced HCC patients. Previous study (ORIENT-32) has confirmed that, compared with sorafenib, sintilimab combined with bevacizumab biosimilar can delay tumor progression, reduce the risk of death, and exhibit a favorable safety profile in patients with advanced HCC. Therefore, we conducted a prospective, single-arm phase II study to investigate the efficacy of sintilimab combined with a bevacizumab biosimilar as neoadjuvant therapy in patients with resectable HCC beyond the Milan criteria.",[113,114,27,115],"Hepatocellular Carcinoma","Neoadjuvant Therapy","Bevacizimab","2026-01-15",{"date":118,"type":36},"2026-01-16",{"date":120,"type":36},"2026-01-14",{"date":122,"type":19},"2030-01",{"name":124,"class":43},"Sun Yat-sen University",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":20,"phases":134,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":73},"100571012","phase-2-low-dose-radiotherapy-combined-with-sintilimab-and-chemotherapy-as-neoadjuvant-therapy-for-stage-ii-iii-nsclc-100571012","NCT06714708","Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC","SPARK: Safety and Efficacy of Low Dose Radiotherapy Combined With Sintilimab and Platinum Based Chemotherapy as Neoadjuvant Therapy for Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients who meet all of the following inclusion criteria are eligible for inclusion in this study:\n\n  1. Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.\n  2. Age ≥ 18 years old.\n  3. Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.\n  4. According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM staging classification of lung cancer, the clinical staging is IIB (primary tumor\\>4cm), IIIA, or IIIB (resectable N2 only) stage. Resectable N2 refers to non bulk (defined as a short diameter less than 3cm), discrete, or single site N2 involvement. If clinically suspected as N2 or N3, pathological confirmation is required.\n  5. Non squamous NSCLC subjects need to undergo genetic testing to confirm the absence of EGFR sensitive mutations and ALK rearrangements. Squamous NSCLC subjects are not required to undergo genetic testing, but subjects with known EGFR sensitive mutations and ALK rearrangements should not be included in the study.\n  6. Considered suitable for radical resection surgery.\n  7. The lung function meets the criteria for planned lung resection (FEV1 ≥ 50% predicted value, MVV ≥ 50% predicted value), and there are no surgical contraindications.\n  8. Can provide sufficient tissue specimens that meet the requirements for PD-L1 testing during the screening period.\n\nAccording to RECIST V1.1, there is at least one measurable lesion. 10. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1.\n\n11\\. Have not received any systemic anti-tumor therapy or local radiotherapy for NSCLC in the past.\n\n12\\. Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous drugs for correcting hematological or liver and kidney dysfunction are allowed within 14 days prior to obtaining laboratory tests), as follows: Hematological function is sufficient, defined as absolute neutrophil count ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 100g\u002FL;\n\n* Adequate liver function, defined as total bilirubin levels ≤ 1.5 × upper limit of normal (ULN) and levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, albumin (ALB) ≥ 35g\u002FL;\n* Adequate renal function, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL\u002Fmin (calculated using the Cockcroft\u002FGault formula), and urine routine test results showing urinary protein (UPRO)\\\u003C2+or 24-hour urine protein dose\\\u003C1g; Within 7 days prior to treatment, the international normalized ratio (INR) is ≤ 1.5 × ULN, and the prothrombin time (PT) or activated partial thromboplastin time (APTT) is ≤ 1.5 × ULN.\n\n  13\\. For female subjects of childbearing age, urine or serum pregnancy tests were negative within 7 days prior to receiving the first study drug administration. 14.If the urine pregnancy test result is positive, a blood pregnancy test is required.\n\n  15.If there is a risk of conception, male and female patients should use highly effective contraception (i.e. methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable as a contraceptive method.\n\nExclusion Criteria:\n\n* 1\\. Histological and pathological examinations show the presence of coexisting small cell carcinoma, large cell neuroendocrine tumor, and sarcomatoid tumor components.\n\n  2\\. Tumors invade the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), trachea, recurrent laryngeal nerve, esophagus, vertebral body, and protuberance.\n\n  3\\. Tumor of the superior sulcus of the lung. 4. There are tumor nodules in the contralateral lung lobe; If there is clinical suspicion of tumor nodules in the contralateral lung lobe, biopsy is required for clarification.\n\n  5\\. Confirm or suspect patients with brain metastases. 6. Currently participating in interventional clinical research treatment, or having received other investigational drugs or devices within the first 4 weeks of randomization.\n\n  7\\. Previous use of anti-PD-1, anti-PD-L1, anti programmed death receptor ligand 2 (PD-L2), or anti cytotoxic T lymphocyte associated antigen 4 (CTLA-4) drugs or any other drugs that act on T cell co stimulatory or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cell immunotherapy.\n\n  8\\. Have received Chinese herbal medicine, traditional Chinese patent medicines and simple preparations with anti-tumor indications, or drugs with immunomodulatory effects (including thymic peptides, interferon, interleukin) within the first two weeks of randomization.\n\n  9\\. Have undergone major surgery within the first 4 weeks of randomization. 10. There are unhealed surgical incisions, ulcers, or fractures present. 11. Received attenuated live vaccine within the first 4 weeks of randomization (or planned to receive attenuated live vaccine during the study period). Note: Accepting inactivated virus vaccines for injection against seasonal influenza is allowed; However, receiving attenuated live influenza vaccines is not allowed.\n\n  12\\. Patients who require long-term systemic use of corticosteroids; Received any other form of immunosuppressive therapy within the first 7 days of randomization. Note: Local corticosteroids administered via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses (≤ 10mg\u002Fday of prednisone or equivalent), or for pre-treatment purposes (such as preventing contrast agent allergies), are allowed.\n\n  13\\. There is a history of non infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease within the previous year of randomization.\n\n  14\\. Within the first 2 years of randomization, there have been active autoimmune diseases that require systemic treatment (such as the use of disease improving drugs, corticosteroids, or immunosuppressants), including but not limited to inflammatory bowel disease, such as ulcerative colitis or Crohn's disease; Diverticulitis; Celiac disease; Systemic lupus erythematosus; Sarcoidosis syndrome or Wegener syndrome (granulomas with polyangitis); Graves' disease; Rheumatoid arthritis; Multiple sclerosis; Vasculitis; Glomerulonephritis; Antiphospholipid syndrome; Pituitary inflammation; Uveitis, etc. Alternative therapies such as thyroid hormone, insulin, or physiological dose corticosteroids used for adrenal or pituitary insufficiency are not considered systemic treatments. Patients with positive autoimmune antibodies need to be evaluated and confirmed by the researcher that there are no autoimmune diseases that require systemic treatment before they can be enrolled.\n\n  15\\. Suffering from primary immunodeficiency disease. 16. Past or current presence of myocarditis. 17. Prior to randomization, there was insufficient recovery from toxicity and\u002For complications caused by any intervention measures (i.e.,\\>grade 1 or not recovered to baseline levels).\n\n  18\\. ≥ Grade 2 peripheral neuropathy. 19. Genetic bleeding tendency or coagulation dysfunction, or history of thrombosis: Any arterial thrombosis, embolism, or ischemia occurred within the first 6 months of randomization, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism. A history of deep vein thrombosis or any other severe thromboembolism within the first 3 months of randomization (implantable venous infusion port or catheter-related thrombosis, or superficial vein thrombosis is not considered a \"severe\" thromboembolism).\n\n  20\\. Uncontrolled hypertension (systolic blood pressure greater than 160mmHg and\u002For diastolic blood pressure greater than 100mmHg); History of hypertensive crisis or hypertensive encephalopathy; Uncontrolled hyperglycemia (fasting blood glucose\\>8.9 mmol\u002FL).\n\n  21\\. Any unstable systemic disease or concurrent disease, including but not limited to:\n  * Active infection (requiring treatment with anti infective drugs or having used systemic anti infective drugs within the week prior to randomization);\n  * Congestive heart failure \\[New York Heart Association (NYHA) classification ≥ II\\]; Serious arrhythmias, liver, kidney or metabolic diseases that require medication treatment;\n  * Untreated coronary atherosclerotic heart disease; Type I or II respiratory failure; History of gastrointestinal perforation and\u002For fistula, intestinal obstruction, extensive intestinal resection, or long-term chronic diarrhea within the past 6 months.\n\n    22\\. Received solid organ or blood system transplantation. 23. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1\u002F2 antibody positive), known active syphilis.\n\n    24\\. Active or tuberculosis requiring medical intervention at this stage, including but not limited to tuberculosis.\n\n    25\\. Active hepatitis B.\n  * Subjects with hepatitis B who meet the following criteria meet the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load before randomization\\\u003C1000 copies\u002Fml or\\\u003C200IU\u002Fml or lower than the detection limit.\n\nHBsAg (+) subjects should receive anti HBV therapy throughout the entire study drug treatment period to avoid viral activation.\n\nFor subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of virus reactivation is necessary.\n\n26\\. Active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit).\n\n27\\. Malignant tumors other than diagnosed NSCLC within the first 5 years of randomization, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery.\n\n28\\. It is known that there is an allergic reaction to the active ingredients and\u002For any excipients of the selected chemotherapy regimen (non squamous NSCLC: pemetrexed plus cisplatin or carboplatin; squamous NSCLC: gemcitabine, docetaxel, paclitaxel or albumin paclitaxel plus cisplatin or carboplatin).\n\n29\\. Pregnant or lactating women or women preparing to become pregnant or breastfeed during the study period.\n\n30\\. It is known that there are mental illnesses or drug abuse situations that may affect compliance with experimental requirements, and there is a history of alcohol abuse.\n\n31\\. There may be medical history, diseases, treatments, or laboratory abnormalities that could interfere with the trial results, hinder the full participation of the subjects in the study, or the researcher believes that participating in the study is not in the best interests of the subjects. Local or systemic diseases caused by non malignant tumors, or secondary reactions to cancer, can lead to higher medical risks and\u002For uncertainty in survival evaluation.",{"count":133,"type":19},86,[22],"To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer",[58,137,138,27],"Neoadjuvant Immunotherapy","Low Dose Radiotherapy",[58,137,138,27],"2025-02-06",{"date":142,"type":36},"2025-02-10",{"date":144,"type":36},"2024-11-20",{"date":146,"type":19},"2027-06-01",{"name":148,"class":43},"Anhui Provincial Cancer Hospital",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":81,"enrollmentInfo":156,"targetDuration":4,"studyType":20,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100551425","phase-2-efficacy-and-safety-of-neoadjuvant-sintilimab-plus-flot-versus-sintilimab-plus-sox-phase-ii-clinical-trial-for-patients-with-locally-advanced-gastric-cancer-100551425","NCT06459921","Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer","Efficacy and Safety of Neoadjuvant Sintilimab Puls FLOT Versus Sintilimab Puls SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer","Inclusion Criteria:\n\n* 1\\. Age \\>=18 years and \\\u003C100 years.\n* 2\\. Diagnosed with locally advanced gastric cancer.\n* 3\\. Eastern Cooperative Oncology Group ECOG PS score 0-1.\n* 4\\. adoption of preoperative chemotherapy treatment and PD-1 antibody therapy.\n* 5\\. deficient mismatch repair identified by pathological detection.\n\nExclusion Criteria:\n\n* 1\\. Locally advanced unable to resect or metastatic tumors.\n* 2\\. Patients with recurrence of residual gastric cancer\n* 3\\. Patients refusing surgical resection after preoperative chemotherapy therapy.\n* 4\\. Have received any anti-tumor therapy such as chemotherapy, radiotherapy, immunotherapy, etc., or have been more than 180 days since the last treatment.\n* 5\\. Patients with confirmed allergy to the study drug and\u002For its excipients.\n* 6\\. Severe malnutrition and active autoimmune diseases.\n* 7\\. Pregnant or lactating women.\n* 8\\. Patients with medical systemic diseases and psychiatric diseases that are not amenable to chemotherapy.\n* 9\\. Patients with acute infections requiring antibiotic treatment.\n* 10\\. Patients with acute infections requiring antibiotic treatment.\n* 11\\. Patients who are concomitantly receiving other immunotherapy, corticosteroids, and other anticancer therapies during the trial.\n* 12\\. Positive test result for hepatitis B or hepatitis C virus.\n* 13\\. Untreated central nervous system metastatic peripheral neuropathy (\\>grade 1).\n* 14\\. History of malignancy within the past 5 years (with the exception of curative, localized cancer).\n* 15\\. Patients who are not expected to achieve R0 resection.\n* 16\\. Weight loss greater than or equal to 20% within 4 weeks before the first dose.\n* 17\\. Patients with multiple factors affecting oral medication.\n* 18\\. Vaccination within 4 weeks prior to the first dose of study drug.\n* 19\\. Patients who have received immune checkpoint inhibitors and develop serious adverse reactions after treatment and need to be permanently disabled.\n* 20\\. The investigator believes that the subject has other serious systemic diseases or other reasons and is not suitable for this clinical study.",{"count":157,"type":19},200,[22],"This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.",[161,27,162],"Neoadjuvant Chemotherapy","Locally Advanced Gastric Cancer","NOT_YET_RECRUITING","2024-10-09",{"date":166,"type":36},"2024-10-10",{"date":168,"type":19},"2024-12-01",{"date":170,"type":19},"2028-12-31",{"name":172,"class":43},"Xijing Hospital",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":52,"enrollmentInfo":180,"targetDuration":4,"studyType":20,"phases":182,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":73},"100521518","btae-haic-combined-with-lenvatinib-and-sintilimab-for-infiltrative-hepatocellular-carcinoma-100521518","NCT06070636","bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma","Sequential bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Diagnosis of infiltrative HCC.\n2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin\n3. Age between 18 and 75 years;\n4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;\n5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).\n6. Child-Pugh class A or B;\n7. Eastern Cooperative Group performance status (ECOG) score of 0-2;\n8. Hemoglobin ≥ 8.5 g\u002FdL Total bilirubin ≤ 30mmol\u002FL Serum albumin ≥ 32 g\u002FL ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT\u002FAPTT within normal limits Absolute neutrophil count (ANC) \\>1,500\u002Fmm3\n9. Prothrombin time ≤18s or international normalized ratio \\\u003C 1.7.\n10. Ability to understand the protocol and to agree to and sign a written informed consent document.\n\nExclusion Criteria:\n\n1. HCC with capsule;\n2. Extrahepatic metastasis \\>5;\n3. Obstructive PVTT involving the main portal vein.\n4. Serious medical comorbidities.\n5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy\n6. Known history of HIV\n7. History of organ allograft\n8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.\n9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy\n10. Evidence of bleeding diathesis.\n11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.",{"count":181,"type":19},30,[183],"NA","This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.",[186,113,187,188,27],"Liver Diseases","Immunotherapy","Lenvatinib","2024-08-08",{"date":191,"type":36},"2024-08-09",{"date":193,"type":36},"2024-05-20",{"date":195,"type":19},"2025-06-30",{"name":124,"class":43},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":15,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":20,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":73},"100547851","phase-2-sintilimab-after-concurrent-chemoradiotherapy-in-elderly-patients-with-esophageal-squamous-cell-carcinoma-100547851","NCT06413342","Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma","Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Randomized, Multi-center Phase II Clinical Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, clinically staged before treatment (8th edition of the UICC\u002FAJCC TNM staging system for esophageal squamous cell carcinoma) as stage II-IVb (cT1N2-3M0-1, cT2-4bN0-3M0-1, M1 limited to supraclavicular lymph node metastasis).\n2. Candidates for curative esophageal cancer surgery who are unable to tolerate surgery or refuse surgery.\n3. Age 70 to 85 years.\n4. ECOG performance status of 0-1.\n5. The minimum technical standard for radiotherapy is intensity-modulated radiotherapy (IMRT). The total dose of radiotherapy is 54Gy ± 10%.\n\n   Note: It is recommended that study centers conduct screening within 14 days after subjects complete synchronous chemoradiotherapy.\n6. Concurrent chemotherapy regimen: Single-agent S-1 70mg\u002Fm2, days 1-14 and 29-42, synchronized with radiotherapy for 14 days or longer.\n7. The last cycle of chemotherapy must end before or concurrently with the last session of radiotherapy. Consolidation chemotherapy after radiotherapy is not allowed, and chemotherapy before chemoradiotherapy is not accepted. Patients who have not progressed after chemoradiotherapy, including complete response (CR), partial response (PR), and stable disease (SD), can be enrolled in this study.\n8. Except for hearing loss, hair loss, and fatigue, all toxicities from previous anti-tumor treatments must have recovered to grade ≤1 (according to the National Cancer Institute \\[NCI\\] Common Terminology Criteria for Adverse Events \\[CTCAE\\] v5.0) or baseline level before enrollment.\n9. The first dose of study medication must be administered within 42 days after completion of chemoradiotherapy.\n10. No esophageal perforation or active esophageal bleeding, no significant invasion of the trachea or major blood vessels in the chest. No interstitial pneumonia or history of interstitial pneumonia. FEV1 ≥ 0.8L.\n11. Expected survival ≥ 3 months.\n12. Laboratory criteria:\n\n    1. Serum hemoglobin ≥ 90g\u002FL, platelets ≥ 100 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL.\n    2. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 40 mL\u002Fmin.\n    3. Serum bilirubin ≤ 1.5 times ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.\n    4. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with an INR within the expected therapeutic range for anticoagulant therapy can be screened).\n13. Patients must sign formal informed consent forms indicating their understanding that this study complies with hospital policies and ethical requirements.\n\nExclusion Criteria:\n\n* 1\\. Patients who underwent surgical resection for esophageal cancer prior to the start of this trial or have previously received treatment with immune checkpoint inhibitors such as anti-PD-1\u002FPD-L1 or CTLA-4 inhibitors.\n\n  2\\. Patients staged as cT1-3N1-2M0, deemed suitable for surgical resection, and requiring surgery.\n\n  3\\. Experience disease progression after chemoradiotherapy. 4. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.\n\n  5\\. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary conditions.\n\n  6\\. Poor nutritional status, with a BMI less than 18.5kg\u002Fm2, or PG-SGA score ≥9. 7. Inability to comprehend trial requirements or likelihood of non-compliance with trial requirements.\n\n  8\\. Presence of hematogenous metastases. 9. Presence of other malignant lesions, excluding curable non-melanoma skin cancer, cervical carcinoma in situ, or malignancies with a cure ≥5 years.\n\n  10\\. Known grade 3 to 4 allergic reactions to any treatment component. 11. Participation in other clinical trials within the past 30 days. 12. Active autoimmune diseases or history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); exceptions include vitiligo or resolved atopic asthma without the need for intervention in adulthood; patients with stable doses of thyroid replacement hormone therapy for autoimmune-mediated hypothyroidism and patients with stable doses of insulin for type I diabetes can be included.\n\n  13\\. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation.\n\n  14\\. Uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA class II or higher heart failure (2) Unstable angina (3) Myocardial infarction within the past year (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n\n  15\\. Active pulmonary tuberculosis infection detected by history or CT examination, or history of active pulmonary tuberculosis infection within the past year before enrollment, or history of active pulmonary tuberculosis infection more than 1 year ago without proper treatment.\n\n  16\\. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 1× 104 copies\u002FmL), hepatitis C (positive HCV antibodies, and HCV-RNA higher than the detection limit of the assay).\n\n  17\\. According to the investigator's judgment, concurrent diseases that pose a serious risk to patient safety or may interfere with patient completion of the study, or other reasons deemed unsuitable for enrollment by the investigator.","70 Years","85 Years",{"count":207,"type":19},191,[22],"This trial is a prospective, randomized, controlled, multicenter, phase II clinical study to evaluate the efficacy and safety of sintilimab as consolidation therapy in elderly patients with esophageal cancer who did not progress after concurrent chemoradiotherapy.\n\nPatients aged 70-85 years with esophageal squamous cell carcinoma who did not progress after concurrent chemoradiotherapy and meet the inclusion criteria will be stratified according to MRD status (positive vs negative) and randomized in a 1:1 ratio into two groups: the treatment group receiving sintilimab (for patients with a weight \\\u003C60 kg: 3 mg\u002Fkg IV on Day 1 every 3 weeks; for patients with a weight ≥60 kg: 200 mg IV on Day 1 every 3 weeks) and the observation group receiving regular follow-up. Patients should receive the first dose within 42 days after completing the last radiotherapy session and continue treatment until disease progression, intolerable toxicity, loss to follow-up, death, or other circumstances where the investigator determines treatment should be discontinued, whichever occurs first. The maximum duration of sintilimab treatment is 12 months (from the start of treatment), while the observation group will be followed up every 3 months for at least one year. No other anti-tumor treatments are allowed during the study period. The study aims to compare the effects of the two treatment modalities on progression-free survival, overall survival, tumor response, toxicity reactions, and quality of life in elderly patients with esophageal cancer.",[211,212,27,187,213],"Esophageal Cancer","Chemoradiotherapy","Elderly Patients","2024-07-12",{"date":216,"type":36},"2024-07-16",{"date":218,"type":36},"2024-06-01",{"date":220,"type":19},"2028-06-01",{"name":100,"class":43},{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":204,"enrollmentInfo":229,"targetDuration":4,"studyType":231,"phases":4,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":243,"locationsCount":73},"100493643","sintilimab-in-combination-with-chemoradiotherapy-in-high-risk-locoregionally-advanced-nasopharyngeal-carcinoma-100493643","NCT05707819","Sintilimab in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma","Sintilimab (PD-1 Antibody) in Combination With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Multicentre, Phase 2 Trial","Inclusion Criteria:\n\n1. Patients with histologically confirmed Non-keratinizing nasopharyngeal carcinoma.\n2. Tumor staged as III-IVA (AJCC 8th, T3-4N2-3M0).\n3. Eastern Cooperative Oncology Group performance status ≤1.\n4. Adequate marrow function: neutrocyte count≥1.5×10e9\u002FL, hemoglobin ≥90g\u002FL and platelet count ≥100×10e9\u002FL.\n5. Alanine Aminotransferase (ALT)\u002FAspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.\n6. Adequate renal function: creatinine clearance rate ≥ 60 ml\u002Fmin (Cockcroft-Gault formula).\n7. Patients must be informed of the investigational nature of this study and give written informed consent.\n8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.\n\nExclusion Criteria:\n\n* 1.Age \\> 70 or \\\u003C 18. 2.Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA \\>1×10e3 copies\u002Fml or 200IU\u002Fml 3.Hepatitis C virus (HCV) antibody positive 4.Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment.\n\n  5.Has a known history of interstitial lung disease. 6.Has any condition that required systemic corticosteroid (equivalent to prednisone \\>10mg\u002Fd) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg\u002Fd, inhale or topical corticosteroid will be allowed.\n\n  7.Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.\n\n  8.Is pregnant or breastfeeding. 9.Has a history of other malignancies except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.\n\n  10.Has known allergy to large molecule protein products or any compound of sintilimab.\n\n  11.Has a known history of human immunodeficiency virus (HIV) infection. 12.Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic\u002Fsocial factors, deemed by the investigator to be likely to interfere with a",{"count":230,"type":19},43,"OBSERVATIONAL","The program aims to enroll patients with stage high risk (AJCC 8th, T3-4N2-3M0) . Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation plus Sintilimab, and then receive 11 cycles of Sintilimab after intensity-modulated radiotherapy (IMRT). All patients will receive IMRT. Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 17 cycles.",[234,27],"Nasopharyngeal Carcinoma",[234,27,236],"high risk","2023-01-29",{"date":239,"type":36},"2023-02-01",{"date":241,"type":36},"2022-07-30",{"date":170,"type":19},{"name":244,"class":43},"Cancer Hospital of Guangxi Medical University"]