[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anti-pd-1-antibody\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anti-pd-1-antibody":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100498526","phase-2-a-novel-combination-therapeutic-strategy-aiming-to-functional-cure-for-chronic-hepatitis-b-virus-infection-sustained-hbsag-loss-b-100498526",false,"NCT05771402","A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (B)","Inclusion Criteria:\n\n* 1\\) Sign the informed consent form before inclusion and be able to complete the study according to the study requirements;\n* 2\\) From inclusion to 30 days after the last administration of the study drug, male subjects or female subjects of childbearing age are willing to voluntarily take effective contraceptive measures;\n* 3\\) 18-70 years old. The weight of male subjects is not less than 45 kg, and the weight of female subjects is not less than 40 kg. Body mass index (BMI) is within the range of 18-32 kg\u002Fm\\^2;\n* 4\\) NAs-naive\u002FNAs-experienced CHB patients.\n\nExclusion Criteria:\n\n* 1\\) A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients;\n* 2\\) Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment;\n* 3\\) Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment;\n* 4\\) Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment;\n* 5\\) Clinically significant acute and chronic liver disease not caused by HBV infection (judged by reseachers);\n* 6\\) Confirmed or suspected decompensated cirrhosis, including but not limited to: hepatic encephalopathy, hepatorenal syndrome, bleeding from esophageal varices, splenomegaly, ascites, etc, or evidence of progressive liver fibrosis;\n* 7\\) Primary liver cancer, or alpha-fetoprotein (AFP) is greater than 50 ug\u002FL or imaging suggests the possibility of malignant liver lesions, or other malignant tumors or a history of other malignant tumors within 5 years before enrollment (except that the malignant tumors have been completely relieved after treatment and patients have not received additional medical or surgical intervention within 3 years before screening);\n* 8\\) A history of pathological fracture or osteoporosis;\n* 9\\) Gastrointestinal dysfunction or gastrointestinal diseases that might affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent gastrointestinal symptoms (such as nausea, vomiting, or diarrhea) \\>2 grades;\n* 10\\) Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, mental, neurological, renal and other systems;\n* 11\\) Major trauma or major surgery within 3 months before enrollment, or planned surgery during the study period;\n* 12\\) Blood donation\u002Floss ≥ 400 mL within 3 months before enrollment, or given a blood transfusion within 3 months before enrollment, or blood donation\u002Floss ≥ 200 mL within 1 month before enrollment;\n* 13\\) Platelet count\\\u003C90 × 10\\^9\u002FL, white blood cell count\\\u003C3.0 × 10\\^9\u002FL, neutrophil count\\\u003C1.3 × 10\\^9\u002FL, total serum bilirubin\\>2 × upper limit of normal (ULN), albumin\\\u003C30 g\u002FL, creatinine clearance ≤ 60 mL\u002Fmin (calculated by CKD-EPI formula), or international normalized ratio of prothrombin time (INR)\\>1.5 (unless receiving stable anticoagulant therapy);\n* 14\\) Hepatitis C virus (HCV) antibody (+), HIV antigen\u002Fantibody (+), or treponema pallidum antibody (+) and rapid plasma regain (RPR) test (+);\n* 15\\) A history of continuous alcohol abuse within 3 years before enrollment (average daily alcohol consumption exceeds 20 gram);\n* 16\\) A history of drug dependence or drug abuse within 1 year before enrollment;\n* 17\\) Those who have participated in clinical trials of other investigational drugs or medical devices and taken investigational drugs or used medical devices within 3 months before enrollment;\n* 18\\) Female in suckling period or pregnancy test (+) during screening;\n* 19\\) Subjects who are considered by the researcher to have other factors that are not suitable for the study","ALL","18 Years","70 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from \"11th Five-Year Plan\" to \"13th Five-Year Plan\", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. (Programmed death-1) PD-1\u002Fprogrammed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) and IFNα in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).",[26,27,28],"Chronic Hepatitis b","Anti-PD-1 Antibody","Peg-IFNα","RECRUITING","2025-09-04",{"date":32,"type":33},"2025-09-11","ACTUAL",{"date":35,"type":33},"2023-10-10",{"date":37,"type":20},"2026-12-31",{"name":39,"class":40},"The Second Affiliated Hospital of Chongqing Medical University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":51,"startDateStruct":52,"completionDateStruct":53,"leadSponsor":54,"locationsCount":41},"100498404","phase-2-a-novel-combination-therapeutic-strategy-aiming-to-functional-cure-for-chronic-hepatitis-b-virus-infection-sustained-hbsag-loss-a-100498404","NCT05769816","A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)",{"count":19,"type":20},[23],"Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of HBV treatment. However, HBsAg loss can be achieved in less than 10% of chronic hepatitis B (CHB) patients treated with current available antiviral drug interferon (IFNα) or nucleos(t)ide analogues (NAs) monotherapy. With the support of the national major special funding for infectious diseases from \"11th Five-Year Plan\" to \"13th Five-Year Plan\", we have implemented a pioneer clinical study of sequential combination of IFNα therapy on NAs to treat NAs-treated CHB patients (ie. New Switch Study). This is the world's first clinical trial aiming to functional cure, which increased the rate of HBsAg loss to 15% in the overall population in our study, and to 30-50% among those with lower baseline HBsAg levels. How to further improve the HBsAg loss rate is an urgent issue for us. The key point of achieving functional cure is to reverse the HBV-specific T cell exhaustion and establish the long-term immune control against HBV infection. Programmed death-1 (PD-1)\u002F programmed death-ligand 1 (PD-L1) axis blockade has been demonstrated to reinvigorate exhausted CD8+ T cells, and would be a potential strategy to treat chronic HBV infection. In this study, a large multicenter prospective study will be performed to explore the safety and efficacy of a novel combination strategy involving immune checkpoint inhibitor (anti-PD-1 antibody) in CHB patients, observe the HBsAg loss rate in NA-treated CHB patients receiving this combination strategy, evaluate the potential of breaking immune tolerance by this strategy, and further assess its efficacy to further improve the clinical cure rate on the basis of New Switch Study. Based on New Switch Study, this study further attempts to reverse T cell exhaustion in CHB patients, explore a novel platform of combination therapy development for clinical cure, and ultimately increase the HBsAg loss rate to higher than 50% in overall patients. The implementation of the project is expected to reduce the burden of HBV infection in China and contribute to the goal of global elimination of hepatitis B and C by 2030 (WHO 2030).",[26,27],{"date":32,"type":33},{"date":35,"type":33},{"date":37,"type":20},{"name":39,"class":40},{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":41},"100411321","phase-1-sintilimab-plus-hypofractionated-radiotherapy-for-msi-hdmmr-rectal-cancer-100411321","NCT04636008","Sintilimab Plus Hypofractionated Radiotherapy for MSI-H\u002FdMMR Rectal Cancer","The Safety and Efficacy of Sintilimab Combined With Hypofractionated Radiotherapy in MSI-H\u002FdMMR Rectal Cancer: a Prospective, Single-arm, Multicenter, Phase Ib Study","Inclusion Criteria:\n\n1. Histologically confirmed rectal adenocarcinoma;\n2. With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch syndrome;\n3. Not received any anti-rectal cancer treatment previously; for patients with Lynch syndrome, not received any anti-tumor therapy about rectal cancer diagnosed this time;\n4. No distant metastasis except for lateral lymph nodes on thoracic and abdominal enhanced computed tomography (CT) scans; the distance between tumor's lower edge and anus within 15cm; clinical T stage ≥T2 on high-resolution pelvic magnetic resonance imaging (MRI)；\n5. Men and women ≥18 years of age;\n6. Eastern Cooperative Oncology Group performance status score 0 or 1;\n7. Adequate hematologic, hepatic, renal, thyroid and cardiac function: hemoglobin ≥90 g\u002FL, neutrophils ≥1500\u002Fmm3, platelets ≥75,000\u002Fmm3; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.5 × ULN; creatinine ≤1.5 × ULN, creatinine clearance ≥50 mL\u002Fmin; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; serum albumin ≥28 g\u002FL；thyroid stimulating hormone and free thyroxine within ±10% of normal levels; no obvious abnormality in electrocardiogram;\n8. Not received blood, blood products and hematopoietic growth factor (e.g. granulocyte colony-stimulating factor) within 2 weeks before inclusion;\n9. Informed consent form signed;\n10. Life expectancy of ≥3 months.\n\nExclusion Criteria:\n\n1. Allergic disease history, severe hypersensitivity to drugs, antibody products or Sintilimab;\n2. Other malignancy history with disease free survival \\\u003C5 years, except for curative in situ cervical cancer, curative skin basal cell carcinoma and curative gastrointestinal cancer by endoscopic mucoresection;\n3. Current or past history of autoimmune diseases, including but not limited to: interstitial lung disease, uveitis, enteritis，active hepatitis (HBV DNA≥103 copies\u002FmL after regular antiviral therapy)，nephritis, hyperthyroidism and hypothyroidism;\n4. Immunosuppressant or corticosteroid (systemic or local) use to suppress immune function within 2 weeks before inclusion;\n5. Severe infection needing intravenous antibiotics, antifungal agents or antiviral drugs, et al;\n6. Congenital or acquired immunodeficiency such as HIV infection; active Hepatitis B (HBV DNA≥103 copies\u002FmL after regular antiviral therapy);\n7. Having one of the following complications: massive gastrointestinal hemorrhage, gastrointestinal perforation or obstruction; symptomatic heart diseases including unstable angina, myocardial infarction and heart failure; uncontrollable diabetes mellitus or hypertension; uncontrollable diarrhea (interfering with daily activities although receiving adequate treatment);\n8. Bleeding tendency or receiving thrombolytic or anticoagulant therapy;\n9. Pregnant or breastfeeding female; male and female unwilling to take any contraceptive measures;\n10. Psychiatric disorders that would interfere with cooperation with the requirements of the study;\n11. Other conditions that investigators consider not suitable for this study.",{"count":63,"type":20},20,[65,23],"PHASE1","This prospective, single-arm study is conducted to investigate the safety and efficacy of Sintilimab combined with hypofractionated radiotherapy in patients with microsatellite instability-high (MSI-H)\u002F DNA mismatch repair-deficient (dMMR) non-metastatic rectal cancer.",[27,68,69,70,71],"Radiotherapy","Rectal Cancer","MSI-H","Mmr Deficiency","2024-08-03",{"date":74,"type":33},"2024-08-06",{"date":76,"type":33},"2020-08-14",{"date":78,"type":20},"2024-12",{"name":80,"class":40},"West China Hospital"]