[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Shengdi Pharmaceutical Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":108},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,63,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100633089","phase-3-clinical-study-of-adebrelimab-therapy-in-the-perioperative-treatment-of-gastric-cancer-or-gastroesophageal-junction-cancer-100633089",false,"NCT07522151","Clinical Study of Adebrelimab Therapy in the Perioperative Treatment of Gastric Cancer or Gastroesophageal Junction Cancer","A Randomized, Double-blind, Multicenter Phase III Trial of Adebrelimab (SHR-1316) Plus S-1 and Oxaliplatin (SOX) Versus Placebo Plus S-1 and Oxaliplatin in the Perioperative Treatment of Resectable Gastric or Gastroesophageal Junction Cancer","Inclusion Criteria:\n\n1. Patients with pathologically confirmed gastric cancer or gastroesophageal junction cancer.\n2. Age: ≥18 years old, \\\u003C75 years old, both male and female are eligible.\n3. Before entering the study, the investigator has evaluated and determined that the subject is suitable and plans to undergo neoadjuvant therapy + radical surgery for curative purposes.\n4. Gastric cancer or gastroesophageal junction cancer applicable to the 8th edition of the AJCC gastric cancer staging criteria.\n5. Fresh specimens (preferred) or formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections obtained within 6 months before randomization can be provided.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1.\n7. Expected survival ≥ 6 months.\n8. Adequate organ and bone marrow function.\n9. Female subjects are either infertile or fertile, with a negative serum pregnancy test result within 3 days before the start of study medication and not in the lactation period. Fertile female subjects and male subjects whose partners are fertile must agree to avoid sperm\u002Fegg donation from the time of signing the informed consent form until 6 months after the last administration of the investigational drug, and comply with relevant contraceptive requirements.\n10. Consent has been obtained from the individual and the informed consent form has been signed, willing and able to comply with planned visits, study treatment, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n1. Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other histological types, or adenocarcinoma mixed with other histological types.\n2. Gastric esophageal junction cancer, Siewert type I; or Siewert type II with esophageal invasion length ≥ 4 cm; or other cases not suitable for clinical staging assessment using the 8th edition of the AJCC gastric cancer staging criteria, or not suitable for conventional surgical methods or approaches for gastric cancer.\n3. The subject's weight has decreased by more than 20% within 2 months before randomization.\n4. Previous anti-tumor treatment for gastric cancer\u002Fgastric esophageal junction cancer (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy or tumor embolization).\n5. Known allergy to any component of the investigational drug (including adibelimab\u002Fplacebo, tegafur, and oxaliplatin), or allergy to humanized monoclonal antibody products.\n6. Diagnosis of any other malignant tumor within 5 years before entering the study, except for locally treatable and cured skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n7. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or organ transplantation (including allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, etc.); history of active autoimmune disease, except for immune disorders that do not require systemic treatment (such as vitiligo, psoriasis, etc.) or autoimmune diseases that can be improved through hormone replacement therapy (such as type 1 diabetes or hypothyroidism).\n8. Severe, unhealed or open wounds, active ulcers, or untreated fractures.\n9. Active severe digestive system diseases.\n10. Presence of interstitial pneumonia or interstitial lung disease.\n11. Severe cardiovascular or metabolic diseases.\n12. Active HBV or HCV infection (HBsAg positive and viral copy number ≥ 2000 IU\u002FmL, HCV antibody positive and HCV RNA above the upper limit of normal at the research center), or co-infection with hepatitis B and hepatitis C.\n13. Active tuberculosis infection within 1 year before randomization (including but not limited to pulmonary tuberculosis, intestinal tuberculosis, etc.), or a history of active tuberculosis infection more than 1 year ago but without regular treatment.\n14. Severe infection within 4 weeks before randomization.\n15. Known history of abuse of psychotropic drugs or drug addiction.\n16. Presence of other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participation in the study, or interfere with the study results, and patients considered unsuitable for participation in the study by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},874,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study was a randomized, double-blind, multi-center phase III clinical trial to evaluate the event-free survival (EFS) of Adebrelimab with S-1 and oxaliplatin versus placebo combined with S-1 and oxaliplatin, and to evaluate the efficacy, safety and tolerability of the two combination regimens.",[27],"Locally Advanced Gastric or Gastroesophageal Junction Cancer","RECRUITING","2026-05-12",{"date":31,"type":32},"2026-05-13","ACTUAL",{"date":34,"type":32},"2026-05-07",{"date":36,"type":21},"2034-02",{"name":38,"class":39},"Shanghai Shengdi Pharmaceutical Co., Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100605874","phase-3-a-phase-iii-clinical-study-of-adebrelimab-combined-with-concurrent-chemoradiotherapy-versus-placebo-combined-with-concurrent-chemoradiotherapy-for-the-treatment-of-locally-advanced-cervical-cancer-100605874","NCT07168200","A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer","A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Participate in the study voluntarily, sign the informed consent form.\n2. Subjects were able to provide primary or metastatic cancer samples.\n3. At least one measurable lesion.\n4. Expected survival \\> 3 months.\n5. ECOG 0 \\~ 1.\n6. With adequate organ functions.\n\nExclusion Criteria:\n\n1. Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.\n2. Administering live vaccines within 4 weeks before enrollment or during planned study treatment.\n3. Participants who received immunosuppressive therapy within 4 weeks before enrolment.\n4. For participants who are receiving thrombolytic\u002Fanticoagulant therapy, prophylactic anticoagulant therapy is allowed.\n5. Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.\n6. Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.\n7. Pregnant or breastfeeding women.\n8. According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.","FEMALE",{"count":50,"type":21},720,[24],"This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).",[54],"Advanced Cervical Cancer","2026-04-12",{"date":57,"type":32},"2026-04-15",{"date":59,"type":32},"2025-10-17",{"date":61,"type":21},"2028-12",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":40},"100610717","phase-1-a-study-of-shr-4610-injection-in-patients-with-advanced-solid-tumors-100610717","NCT07231211","A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors","An Open-label, Multicenter Phase I\u002FII Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n2. Age range: 18-75 years old, both male and female are welcome;\n3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;\n4. Have at least one measurable tumor lesion per RECIST v1.1;\n5. ECOG performance status of 0-1;\n6. Life expectancy ≥ 12 weeks;\n7. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases or meningeal metastases;\n2. Systemic antitumor therapy was received 4 weeks before the start of the study;\n3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;\n4. Have poorly controlled or severe cardiovascular disease;\n5. Subjects with active hepatitis B or active hepatitis C;\n6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.",{"count":71,"type":21},258,[73,74],"PHASE1","PHASE2","This study is an open, multicenter Phase I\u002FII clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.",[77],"Solid Tumors","2026-01-07",{"date":80,"type":32},"2026-01-09",{"date":82,"type":32},"2025-11-20",{"date":84,"type":21},"2027-12",{"name":38,"class":39},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":40},"100541860","phase-2-a-phase-iiiii-study-of-adebrelimab-in-combination-with-shr-8068-and-chemotherapy-in-advanced-or-metastatic-nsclc-patients-100541860","NCT06335355","A Phase II\u002FIII Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients","A Phase II\u002FIII, Randomized, Open-label, Parallel-controlled, Multicenter Study of Adebrelimab (SHR-1316) in Combination With SHR-8068 and Platinum-based Doublet Chemotherapy as First-line Treatment in Advanced or Metastatic NSCLC Patients With STK11\u002FKEAP1\u002FKRAS Mutations","Inclusion Criteria:\n\n1. The participant voluntarily joins this clinical research study, understands the research procedures, and is capable of providing written informed consent by signing the Informed Consent Form.\n2. At the time of signing the Informed Consent Form, participants must be between the ages of 18 and 75 years old (inclusive), with no gender restrictions.\n3. Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.\n4. At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .\n5. The participant is expected to have a life expectancy of at least 12 weeks.\n6. Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed.\n7. The participant must have adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.\n2. Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.\n3. Subjects with spinal cord compression that has not been radically treated by surgery and\u002For radiotherapy.\n4. Subjects with inadequately controlled pain related to their tumor(s).\n5. Subjects with a history of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, in situ cervical cancer, localized prostate cancer, ductal carcinoma in situ following mastectomy (allowing for hormonal treatment for non-metastatic prostate or breast cancer), and papillary thyroid cancer which have achieved complete remission for at least 5 years prior to screening and do not require or are not expected to require further treatment during the study period.\n6. Subjects who have received Chinese herbal anti-tumor treatment within 2 weeks prior to initiating the study treatment.\n7. Subjects whose toxicities and\u002For complications from previous interventions have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) Grade ≤1.\n8. Subjects participating in another clinical study or whose initiation of study treatment is less than 4 weeks since the end of the last clinical study (last dose administration), or less than five half-lives of that study drug, whichever is shorter.\n9. Subjects who have received systemic immunostimulant treatment within 4 weeks prior to starting the study treatment.\n10. Subjects who have received systemic immunosuppressive treatment within 2 weeks prior to starting the study treatment.\n11. Subjects with any active, known, or suspected autoimmune disease.\n12. Subjects with severe heart disease.\n13. Subjects who have experienced arterial or venous thrombotic events within 3 months prior to starting the study treatment.\n14. Subjects with active syphilis infection.\n15. Subjects who have had a severe infection within 4 weeks prior to starting the study treatment.\n16. Subjects who have previously undergone or are planning to undergo allogeneic hematopoietic stem cell transplantation or organ transplantation.\n17. Subjects with a history of severe hypersensitivity reactions to other monoclonal antibodies.\n18. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n19. Subjects with a history of substance abuse of psychoactive drugs, alcoholism, or drug addiction.\n20. Subjects whom the investigator believes have any medical condition (such as pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric conditions, or social circumstances that could potentially interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate, and participate in the study, or interfere with the assessment of the investigational drug, interpretation of subject safety data, or study results.",{"count":94,"type":21},401,[74,24],"Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11\u002FKEAP1\u002FKRAS Mutations",[98],"Non-squamous Non-small Cell Lung Cancer","NOT_YET_RECRUITING","2024-03-21",{"date":102,"type":32},"2024-03-28",{"date":104,"type":21},"2024-03",{"date":106,"type":21},"2030-10",{"name":38,"class":39},""]