[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Junshi Bioscience Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":484},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,40,64,83,102,123,144,164,187,209,231,252,273,294,315,333,353,378,399,420,441,462],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100580577","phase-1-a-clinical-study-to-evaluate-the-safety-and-tolerability-of-awt020-in-patients-with-advanced-malignancies-100580577",false,"NCT06839105","A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AWT020 Alone and in Combination With Other Antitumor Therapies in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Both male and female subjects who are at least 18 years old at the time of signing the consent form;\n2. Inclusion of patients with advanced malignancies confirmed histologically or cytologically and meeting the following requirements:\n\n   * Single-agent dose escalation and expansion phase to include patients with advanced malignant tumors who have failed or are intolerant of standard treatment, or have no standard treatment options;\n   * Therapeutic effect expansion stage of single drug:\n\n     1. NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has progressed after prior treatment with PD-(L)1 antibody and platinum-containing chemotherapy (except after the last dose \\> Progression of adjuvant and neoadjuvant therapy within 6 months). Subjects with EGFR or ALK mutations will need to progress with prior treatment with appropriate kinase inhibitors.\n     2. Melanoma: histologically unresectable stage III or IV melanoma that has progressed after prior chemotherapy and treatment with PD-(L)1 inhibitors (except after the last dose \\> Adjuvant and neoadjuvant therapy that progresses within 6 months); Mucosal melanoma does not require prior PD-(L)1 inhibitor therapy.\n     3. CRC: colorectal adenocarcinoma or rectal adenocarcinoma with histologically confirmed PD-L1 composite positive score \\[CPS\\] ≥1, failure or intolerance of standard treatment, or no standard treatment options. PD-L1 expression levels in tumor tissues are based on the results of the central laboratory tests designated by the sponsor (the inclusion criteria for PD-L1 expression levels can also be adjusted according to previous data during the study).\n     4. RCC: Histologically confirmed metastatic or unresectable clear cell type of RCC with disease progression after previous treatment with targeted anti-angiogenesis therapy and PD-(L)1 inhibitors.\n     5. Other advanced malignancies: patients with advanced malignancies who have failed or been intolerant to standard treatment or have no standard treatment options.\n   * Combination phase:\n\n     1. NSCLC: histologically or cytologically confirmed, unresectable locally advanced, relapsed, or distant metastatic NSCLC that has not progressed after prior treatment with PD-(L)1 antibody and platinum-containing chemotherapy (except after the last dose \\> Progression of adjuvant and neoadjuvant therapy within 6 months). Subjects carrying EGFR or ALK mutations were allowed to progress on kinase inhibitor therapy with a previous ≤1 line.\n     2. CRC: Histologically confirmed PD-L1 CPS≥1 colorectal adenocarcinoma or rectal adenocarcinoma without prior systemic therapy (except after the last dose of medication \\> Adjuvant therapy that progresses within 6 months); In patients with MSI-H\u002FdMMR, previous treatment with PD-(L)1 inhibitors is permitted. PD-L1 expression levels in tumor tissues are based on the results of the central laboratory tests designated by the sponsor (the inclusion criteria for PD-L1 expression levels can also be adjusted according to previous data during the study).\n     3. RCC: Histologically confirmed metastatic or unresectable clear cell RCC with disease progression after previous treatment with anti-angiogenesis targeted therapy and PD-(L)1 inhibitors.\n     4. Melanoma: histologically unresectable stage III or IV melanoma that has progressed after prior chemotherapy and treatment with PD-(L)1 inhibitors (except after the last dose \\> Adjuvant therapy that progresses within 6 months).\n     5. HCC: Histologically\u002Fcytologically confirmed or cirrhotic patients meet the clinical diagnostic criteria for HCC in AASLD, are identified as having stage B (intermediate) or stage C (advanced) BCLC HCC and are not candidates for radical surgery and\u002For local therapy, and have previously received PD-(L)1 inhibitors and anti-angiogenic targeted therapy progression.\n     6. Other advanced malignancies: patients with advanced malignancies who have failed or been intolerant to standard treatment, or have no standard treatment options.\n3. ECOG score is 0 or 1;\n4. Expected survival ≥12 weeks;\n5. Have at least one measurable lesion according to RECIST 1.1 evaluation criteria;\n6. Good organ function;\n7. Fertile female or male subjects must agree to be childfree during the study period until 6 months after the end of the last dose and voluntarily take highly effective contraception with their partner; The serum pregnancy test for WOCBP must be negative within 7 days prior to the first dose and must be non-lactation (specific contraceptive methods and WOCBP definitions are set out in section 10.3);\n8. Patients participate voluntarily, give full informed consent, sign written informed consent, and have good compliance.\n\nExclusion Criteria:\n\n1. Received the following drugs or treatments before the first dose:\n\n   1. received chemotherapy, immunotherapy and other anti-tumor therapy or other investigational drugs within 21 days before the first dose, or received oral fluorouracil, small molecule targeted drugs or Chinese medicines with anti-tumor indications within 14 days before the first dose;\n   2. Major surgery or radiotherapy within 28 days before the first dose (palliative radiotherapy for local bone\u002Fbrain lesions allowed within 14 days before the first dose), coarse needle puncture biopsy or other minor surgery within 7 days before the start of study therapy, excluding placement of vascular infusion devices;\n   3. In combination therapy, patients who have been systematically treated with corticosteroids (\\> 10 mg prednisone per day or equivalent) or other immunosuppressants for more than 1 week within 2 weeks prior to initial administration are allowed to be treated with inhaled or topical steroids or ≤10 mg\u002F day systemic prednisone and equivalent doses of similar drugs;\n2. There is active central nervous system metastasis. If the patient has received radiotherapy or surgery in the past, imaging examination within 4 weeks before the first medication indicates stable brain metastases without aggravation or new neurological symptoms, hormone therapy has been discontinued 2 weeks before the first medication, and screening is allowed; For meningeal and brainstem metastases, screening is not allowed regardless of treatment.\n3. Immune-related adverse events that led to permanent discontinuation occurred during previous immunosuppressive therapy (such as anti-PD -(L)1, CTLA-4, LAG-3 inhibitors, etc.);\n4. There are pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms that require repeated treatment (puncture or drainage, etc.);\n5. There is a history of interstitial lung disease or a history of non-infectious pneumonia treated with corticosteroids, or imaging evidence of active pneumonia during the screening period;\n6. The presence of severe, unhealed or split wounds, active ulcers, or untreated fractures (other than old fractures assessed by the investigator without clinical intervention);\n7. Obvious bleeding tendency or severe coagulation dysfunction;\n8. Have poorly controlled hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), or have a history of hypertensive crisis or hypertensive encephalopathy;\n9. The toxicity of previous antitumor therapy did not return to the level ≤ Class 1 prescribed by CTCAE v5.0 or the level specified by the inclusion\u002Fexclusion criteria, except in the following cases: The related toxicity judged by the investigator to be well controlled and does not affect the safety and compliance of patients using the investigational drugs can be screened after confirmation with the sponsor;\n10. Severe infection occurred within 28 days prior to administration in the first study (CTCAE v5.0\\> Grade 2), such as severe pneumonia, bacteremia, infection complications that require hospitalization; Active infection requiring intravenous anti-infective therapy or fever of unknown origin \\> 38.5℃ occurred within 2 weeks prior to the first study administration (as determined by the investigators, subjects with fever due to tumors could be enrolled);\n11. Clinically significant hemoptysis for any reason (such as blood loss reaching or exceeding 50 ml\u002F day, or accompanied by clinical symptoms such as dyspnea and shortness of breath) or tumor bleeding (such as significant bleeding caused by tumor, manifested as hemoptysis, hematemesis, bloody stool, etc., and the blood loss reaching 50 ml\u002F day or more) within 1 month before the first medication, Or accompanied by anemia, hypotension, shock and other symptoms);\n12. Gastrointestinal perforation, fistula, abdominal abscess, bleeding, or definite bleeding tendency (including but not limited to: severe esophagofundus varicose veins with bleeding risk, locally active digestive ulcer lesions \\[may be considered in investigators' assessment of ulcer stability\\], persistent positive stool occult blood, etc.) within 6 months before randomization; For patients with persistent positive stool occult blood, if they are patients with colorectal cancer or gastric cancer, and the positive occult blood test is believed to be related to tumor after detailed evaluation (such as local bleeding, ulcers, etc.), gastrointestinal bleeding is stable and does not cause clinical symptoms (such as anemia, hypotension, etc.) under tumor treatment or disease control, they can be considered for inclusion;\n13. Severe cardiovascular and cerebrovascular diseases, including but not limited to, History of myocardial infarction, severe\u002Funstable angina pectoris, congestive heart failure (NYHA cardiac function rating ≥2), clinically significant supratrioventricular or ventricular arrhythmia requiring pharmacological intervention, aortic aneurysm requiring surgical repair, any arterial thromboembolism\u002Fembolism event, grade 3 or higher (CTCAE) within 6 months prior to administration v5.0) Venous thrombosis\u002Fembolism events, transient ischemic attacks, cerebrovascular accidents; Left ventricular ejection fraction (LVEF) by color Doppler ultrasound \\< 50%. Corrected QTc\\> 480ms (using the Fridericia method, if the QTc is abnormal, it can be detected three times at an interval of 2 minutes, and the average value is calculated);\n14. Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) are present within 2 years prior to initial medication, including but not limited to systemic systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, only thyroid, adrenal, or hypopituitarism, type 1 diabetes that can be controlled with hormone replacement therapy, psoriasis or vitiligo that does not require systemic treatment, and childhood asthma\u002Fallergies that have resolved are eligible for screening;\n15. Had suffered from another malignant tumor within 5 years before the first medication; However, local tumors that have been cured are excluded, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ;\n16. Active tuberculosis, hepatitis B (HBsAg positive with HBV DNA higher than 1000 copies \u002Fml or 200 IU\u002Fml), hepatitis C (HCVAb positive with HCV RNA higher than the lower limit of detection);\n17. A history of immunodeficiency, including HIV testing positive, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n18. The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participation in the study, affect treatment compliance, or interfere with the study results, patients who are judged by the investigator to be unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},214,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this phase I clinical study was to evaluate the safety and tolerability of AWT020 monotherapy and combination with other antitumor therapies in patients with advanced malignancies",[26],"Non-Small Cell Lung Cancer, Colorectal Cancer, Renal Cell Carcinoma, Melanoma and Other Solid Tumor","RECRUITING","2026-06-30",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2025-02-21",{"date":35,"type":20},"2028-04-30",{"name":37,"class":38},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",13,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100629904","phase-2-phase-ii-study-of-js212js213-as-monotherapy-and-in-combination-in-patients-with-advanced-malignant-solid-tumors-100629904","NCT07480733","Phase II Study of JS212\u002FJS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors","A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age 18 to 75 years, male or female.\n2. Histologically confirmed metastatic or unresectable clear cell renal cell carcinoma (RCC); histologically or cytologically confirmed metastatic or unresectable castration-resistant prostate cancer (CRPC); histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC); histologically confirmed unresectable Stage III or IV melanoma.\n3. For RCC: disease progression following prior anti-angiogenic targeted therapy and PD-(L)1 inhibitor therapy; for CRPC: disease progression following prior abiraterone or novel androgen receptor (AR) inhibitor therapy; for UC: disease progression following prior PD-(L)1 inhibitor and platinum-based chemotherapy or PD-(L)1 inhibitor and ADC drugs; for melanoma: disease progression following prior chemotherapy and\u002For PD-(L)1 inhibitor therapy.\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Life expectancy ≥ 12 weeks.\n7. Adequate organ function.\n8. Male and female subjects of reproductive potential must agree to use highly effective contraception during the study and avoid conception; women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose and must not be breastfeeding.\n9. CRPC subjects must be on continuous luteinizing hormone-releasing hormone agonist (LHRHa) therapy or have undergone bilateral orchiectomy; subjects without bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the study; castrate levels of testosterone at screening; metastatic disease confirmed by CT\u002FMRI or radionuclide bone scan.\n10. Subjects voluntarily participate in the study and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Major surgery, radiotherapy, chemotherapy, immunotherapy or other anti-tumor therapy, or other investigational agents administered prior to the first study dose.\n2. Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion\u002Fexclusion criteria.\n3. Presence of active central nervous system (CNS) metastases.\n4. Presence of clinically significant pleural effusion, ascites, or pericardial effusion requiring repeated intervention.\n5. Uncontrolled hypertension despite medical therapy, or history of hypertensive crisis or hypertensive encephalopathy.\n6. Severe cardiovascular or cerebrovascular disease.\n7. History of interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis requiring corticosteroid therapy.\n8. Severe bone injury due to tumor bone metastasis as judged by the investigator.\n9. Severe infection (CTCAE v6.0 \\> Grade 2) within 28 days prior to the first study dose.\n10. Active tuberculosis, hepatitis B, or hepatitis C infection.\n11. History of immunodeficiency, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n12. History of another primary malignancy, except those with curative treatment and no known active disease for \\>5 years and low potential risk of recurrence.\n13. Known hypersensitivity or severe allergic reaction to the study treatment, any of its components, or excipients.\n14. Presence of any other condition that may result in premature discontinuation from the study.\n15. Diagnosis of any other malignancy within 5 years.\n16. Subjects participating in Cohorts 1, 3, 4, and 5:Prior treatment with an ADC targeting EGFR and\u002For HER3, or prior treatment with an ADC utilizing a topoisomerase I inhibitor as the payload；\n17. Subjects participating in Cohorts 2, 3, 4, and 5: Administration of any live or live-attenuated vaccine within 28 days prior to the first dose, or anticipated need for such vaccination during the study.Use of systemic corticosteroids or other immunosuppressive agents for ≥7 consecutive days within 14 days prior to the first dose.Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.Development of a drug-related adverse event leading to permanent discontinuation of prior anti-PD-(L)1 antibody therapy.\n18. Subjects participating in Cohorts 4:Imaging in the screening period demonstrates tumor encasement of major blood vessels, significant necrosis, or cavitation that, in the investigator's opinion, may confer a bleeding risk. Clinically significant hemoptysis or tumor bleeding of any cause within 28 days prior to the first dose.Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to enrollment, or current high risk of hollow organ perforation\u002Ffistula formation as judged by the investigator.History of gastrointestinal bleeding within 6 months prior to enrollment, or documented gastrointestinal bleeding tendency.Severe, non-healing or dehiscent wound, active ulcer, or untreated fracture.Significant bleeding diathesis or severe coagulopathy.Use of antiplatelet therapy or therapeutic anticoagulation within 14 days prior to the first dose.Development of a drug-related adverse event leading to permanent discontinuation of prior bevacizumab or similar agent therapy.","75 Years",{"count":49,"type":20},410,[51],"PHASE2","This is a multicenter, open-label Phase II clinical study. The primary objective is to evaluate the investigator-assessed objective response rate of JS212 and JS213 as monotherapy and in combination regimens in patients with advanced solid tumors. This study aims to explore the safety, tolerability, and preliminary efficacy of JS212, JS213, as well as JS212 in combination with JS213, toripalimab, and JS207.",[54],"Advanced Malignant Solid Tumors","2026-05-26",{"date":57,"type":31},"2026-05-29",{"date":59,"type":31},"2026-04-23",{"date":61,"type":20},"2028-11-11",{"name":37,"class":38},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":63},"100616720","phase-2-a-phase-ii-clinical-study-evaluating-the-combination-therapy-of-js212-in-patients-with-advanced-lung-cancer-100616720","NCT07309276","A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer","Inclusion Criteria:\n\n1. The age between 18 and 75 years old, and any gender.\n2. Local advanced, metastatic or recurrent NSCLC.\n3. ES-SCLC.\n4. According to the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), there must be at least one measurable lesion.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Expected survival period of ≥ 12 weeks.\n7. The functions of important organs meet the requirements.\n8. Female participants with reproductive capacity (WOCBP) who have sexual life with an unsterilized male partner and who have signed the informed consent must have a negative serum pregnancy test result within 7 days before the first administration, and must agree to take effective contraceptive measures from the time of signing the ICF until 7 months after the last administration of the study.\n9. Unsterilized male participants who have sexual life with a fertile female partner must agree to use the effective contraceptive measures after signing the ICF until 4 months after the last administration of the study. During this period, sperm donation is prohibited.\n10. The participants voluntarily participate in this study and sign the informed consent.\n\nExclusion Criteria:\n\n1\\. Accompanying the following disease states:\n\n1. Tumor histological or cytological pathological confirmation of combined large cell neuroendocrine carcinoma or sarcomatoid lesion, or NSCLC with small cell lung cancer component;\n2. NSCLC patients with positive driver mutations;\n3. Patients with known meningeal metastasis;\n4. Patients with symptomatic brain metastases;\n5. Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites;\n6. Unatable spinal cord compression;\n\n2\\. Participants in Cohort 1 and Cohort 4 need to exclude any of the following conditions:\n\n1. Within one month before the first use of the study drug, any clinically significant hemoptysis or tumor bleeding;\n2. High bleeding risk; tumor invading important organs, high risks of perforation, esophageal-tracheal fistula, massive hemoptysis, etc.;\n3. Obvious bleeding tendency or severe coagulation dysfunction history, etc;\n4. Recent gastrointestinal perforation, gastrointestinal obstruction, trachea-esophageal fistula, abdominal fistula or intra-abdominal abscess, or currently having high-risk factors for hollow organ perforation\u002F fistula formation, or active inflammatory bowel disease, etc;\n5. Presence of severe, non-healed or open wounds, active ulcers or untreated fractures;\n6. Have poorly controlled hypertension;\n7. Have used antiplatelet drugs or anticoagulant therapy within 14 days;\n8. Have experienced a drug-related adverse event that led to permanent discontinuation of the medication during previous Bevacizumab and similar agent treatments;\n\n3\\. Have received any of the following treatments:\n\n1. Immune-mediated treatments (only for part Two);\n2. Have received any investigational drug within 4 weeks or 5 half-lives before the first use of the study drug;\n3. Have been enrolled in another clinical study;\n4. Have undergone major surgery within 4 weeks;\n5. Have received local small-scale radiotherapy within 14 days;\n\n4.Have not recovered to ≤ CTCAE grade 1 toxicity or the level specified in the inclusion\u002Fexclusion criteria.\n\n5.Have known allergies to any study treatment or its excipients or have experienced an allergic reaction.\n\n6.Have experienced a drug-related AE that led to permanent discontinuation of the anti-PD-(L)1 antibody treatment.\n\n7.Have any of the following cardiac examination results:\n\n1. Long QT;\n2. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n8.Have a history of diagnosed or suspected ILD, drug-induced pneumonia, or other severe lung diseases.\n\n9.Have experienced a severe infection within 4 weeks.\n\n10.Have a history of immunodeficiency, or have a history of organ transplantation and allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n\n11.Have active pulmonary tuberculosis infection.\n\n12.Have active hepatitis.\n\n13\\. Uncontrolled concurrent diseases.\n\n14\\. Participants who were diagnosed with any other malignant tumor within 5 years.\n\n15\\. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n\n16\\. Other conditions for trial participation were not considered appropriate by the investigator.",{"count":71,"type":20},864,[51],"This is a multicenter, open-label Phase II clinical study, with the main objective being to evaluate the investigator-assessed objective response rate of JS212 in combination therapy for advanced lung cancer. The aim is to explore the safety, tolerability, and preliminary efficacy of JS212 combined with JS207, Toripalimab, JS213 combined or not combined with chemotherapy.",[75],"Advanced Lung Cancer","2026-05-14",{"date":78,"type":31},"2026-05-18",{"date":80,"type":31},"2026-01-23",{"date":61,"type":20},{"name":37,"class":38},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":63},"100582863","phase-2-phase-ii-clinical-study-of-js207-pd-1vegf-bispecific-antibody-combination-therapies-in-patients-with-driver-gene-positive-advanced-non-small-cell-lung-cancer-after-failure-of-tki-therapy-100582863","NCT06868836","Phase II Clinical Study of JS207 (PD-1\u002FVEGF Bispecific Antibody) Combination Therapies in Patients With Driver Gene-Positive, Advanced Non-Small Cell Lung Cancer After Failure of TKI Therapy","Inclusion Criteria:\n\n1. Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.\n2. Locally advanced (stage IIIB\u002FIIIC), metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.\n3. Positive for driver genes, including but not limited to any of the following: EGFR sensitive mutations (18 exon G719X mutation, 19 exon deletion mutation, 20 exon S768I or T790M mutation, 21 exon L858R or L861Q mutation), ALK fusion, ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET14 exon skipping mutation, RET fusion, KRAS G12C mutation, HER-2 mutation, EGFR 20 exon insertion mutation.\n4. Previous targeted therapy failed and there is currently no standard targeted treatment available.\n5. Cohort1: PD-L1 positive (TPS ≥ 1%) confirmed by the central laboratory or the research center. Cohort2:: Organized samples must be provided for the central laboratory to conduct retrospective biomarker testing (which may include PD-L1, EGFR and HER3 expression).\n6. Being able to provide a qualified test report for positive driver gene, or agreeing to provide a qualified sample for driver gene testing.\n7. According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.\n8. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.\n9. Expected survival period ≥ 12 weeks.\n10. The function of important organs meets the requirements of the protocol.\n11. For female subjects with reproductive capacity who have sexual relations with unsterilized male partners, they must agree to have no pregnancy plans and to take effective contraceptive measures during the period from signing the ICF to 7 months after the last administration of JS212, or 6 months after the last administration of JS207 or chemotherapy drugs (whichever is the longer period of contraceptive requirement). For unsterilized male subjects who maintain sexual relations with female partners with reproductive capacity, they must agree to take effective contraceptive measures during the period from signing the ICF to 4 months after the last administration of JS212, or 6 months after the last administration of JS207 or chemotherapy drugs (whichever is the longer period of contraceptive requirement) (Appendix 4). For female patients with reproductive capacity, the HCG test in the 7 days prior to study enrollment must be negative and they must be non-lactating.\n12. Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.\n\nExclusion Criteria:\n\n1. Diseases accompanied by those listed in the protocol, including those with histopathological or cytopathological confirmation of the tumor combined with neuroendocrine tumor (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) components, or with the squamous cell carcinoma component exceeding 10%; known meningeal metastasis; symptomatic brain metastasis; the tumor encircling important blood vessels or with obvious necrosis and cavities, and the investigator deems that it may pose a risk of bleeding, etc.\n2. Received the treatments listed in the plan, including immune-mediated treatments; systemic chemotherapy, anti-VEGF pathway target drugs, anti-EGFR and\u002For HER3 target drugs, and ADC drugs containing topoisomerase inhibitors (only applicable to cohort 2).\n3. Having an obvious bleeding tendency or a history of severe coagulation dysfunction.\n4. Gastrointestinal perforation, intra-abdominal fistula or intra-abdominal abscess occurred within 6 months before the first administration, or currently having high-risk factors for perforation\u002Ffistula formation of the hollow viscus as judged by the investigator.\n5. Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.\n6. Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.\n7. Expected that the toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE).\n8. Known allergy to the investigational drug or its excipients, pemetrexed, platinum drugs (carboplatin\u002Fcisplatin), or known history of ≥ grade 3 allergy to antibody drugs in the past.\n9. Having an active autoimmune disease or a history of autoimmune disease.\n10. Having a history of immunodeficiency.\n11. Having a severe infection within 4 weeks before the first use of the investigational drug.\n12. History of confirmed or suspected interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonia, idiopathic pneumonia, or other moderate to severe lung diseases that seriously affect lung function.\n13. Active pulmonary tuberculosis infection detected by medical history or CT examination.\n14. Having active tuberculosis, hepatitis B, or hepatitis C.\n15. Having been diagnosed with any other malignant tumor within 5 years before the first use of the investigational drug.\n16. Uncontrolled concurrent diseases listed in the protocol.\n17. As judged by the investigator, having other severe, acute or chronic medical diseases, mental diseases or laboratory abnormalities that may increase the risk associated with participating in the study, or may interfere with the interpretation of the study results. \"",{"count":90,"type":20},78,[51],"This study targets patients with advanced NSCLC driven with positive driver genes who have failed TKI treatment, enrolling 66-78 participants. Cohort1 ：Patients will receive JS207 (10 or 15 mg\u002Fkg, IV, d1) + pemetrexed (500 mg\u002Fm², IV, d1) + platinum-based chemotherapy (carboplatin Area Under the Curve(AUC)5 or cisplatin 75 mg\u002Fm², d1) every 3 weeks for 4 cycles. Afterward, JS207 and pemetrexed will continue as maintenance therapy until discontinuation criteria are met. Cohort2 ：The treatment received was JS207 (10mg\u002Fkg, intravenous, on day 1) + JS212 (4.2mg\u002Fkg or another SMC-selected dose, intravenous, on day 1), every 3 weeks, until the termination criteria were met. The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.",[94],"Non-squamous Non-small Cell Lung Cancer","2026-05-13",{"date":78,"type":31},{"date":98,"type":31},"2025-03-30",{"date":100,"type":20},"2028-04-04",{"name":37,"class":38},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":63},"100631674","phase-2-js212-combination-therapies-in-metastatic-colorectal-cancer-100631674","NCT07503756","JS212 Combination Therapies in Metastatic Colorectal Cancer","An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1Participants must meet the following key criteria\n* Adults aged 18-75 years with histologically confirmed metastatic colorectal adenocarcinoma\n* Microsatellite stable (MSS) or mismatch repair proficient (pMMR) disease\n* No prior systemic therapy for advanced or metastatic disease\n* At least one measurable lesion according to RECIST v1.1\n* ECOG performance status 0-1\n* Adequate hematologic, hepatic, renal, and coagulation function\n* Life expectancy ≥12 weeks\n* Willingness to provide tumor tissue samples for biomarker analyses\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded\n* Prior treatment with EGFR- or HER3-targeted antibody-drug conjugates or topoisomerase I inhibitor-based ADCs\n* Recent major surgery, radiotherapy, or systemic anticancer therapy prior to study treatment\n* Active or uncontrolled infections or significant cardiovascular disease\n* Known active central nervous system metastases\n* History of autoimmune disease requiring systemic therapy\n* Significant bleeding disorders or high risk of hemorrhage\n* Active viral infections such as uncontrolled hepatitis B, hepatitis C, or HIV\n* Any other serious medical or psychiatric condition that may interfere with study participation",{"count":110,"type":20},80,[51],"This is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC).\n\nJS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3 with a topoisomerase I inhibitor payload. Preclinical and early clinical data suggest that dual targeting of EGFR and HER3 may enhance antitumor activity and overcome resistance mechanisms associated with EGFR- or HER2-directed therapies.\n\nThis study will investigate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (XELOX: capecitabine and oxaliplatin), with or without the PD-1\u002FVEGF bispecific antibody JS207, in patients with mCRC.\n\nThe study will assess safety, determine the recommended Phase 3 dose (RP3D), and evaluate preliminary antitumor activity of the combination regimens.",[114],"Metastatic Colorectal Cancer","2026-04-29",{"date":117,"type":31},"2026-05-05",{"date":119,"type":31},"2026-04-25",{"date":121,"type":20},"2028-03-30",{"name":37,"class":38},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":63},"100630211","phase-2-a-study-evaluating-the-safety-and-efficacy-of-js212-combination-therapy-in-patients-with-advanced-esophageal-squamous-cell-carcinoma-100630211","NCT07484724","A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma","An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (ESCC)","Inclusion Criteria:\n\n1. Male or female subjects aged 18 to 75 years (inclusive) at the time of signing the Informed Consent Form (ICF).\n2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) that is locally advanced, recurrent, or metastatic, and not amenable to radical treatment.\n3. No prior systemic anti-tumor therapy. For patients who received neoadjuvant\u002Fadjuvant therapy or radical concurrent chemoradiotherapy, the interval from the last dose of chemotherapy to disease recurrence or progression must be \\> 6 months to be eligible for screening.\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Expected survival ≥ 12 weeks\n\nExclusion Criteria:\n\n1. Prior treatment with any of the following: anti-PD-1 or anti-PD-L1 antibody therapy; ADC therapy targeting EGFR and\u002For HER3, or ADC therapy with a topoisomerase I inhibitor as the toxic payload;\n2. Subjects at high risk of bleeding or esophageal fistula, e.g., lesions with large ulcers or direct invasion of vital adjacent organs such as the aorta or trachea;\n3. Subjects with a history of gastrointestinal perforation and\u002For fistula within 6 months prior to the first dose;\n4. Presence of active central nervous system (CNS) metastases;\n5. Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose;\n6. Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion\u002Fexclusion criteria;\n7. Severe cardiovascular or cerebrovascular disease;\n8. Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；",{"count":131,"type":20},280,[51],"This study is an open-label, multi-center phase II clinical trial aimed to evaluat the safety and preliminary efficacy of JS212 combination therapy in patients with advanced esophageal squamous cell carcinoma (ESCC).",[135],"Advanced Esophageal Squamous Cell Carcinoma","2026-04-21",{"date":138,"type":31},"2026-04-22",{"date":140,"type":31},"2026-04-13",{"date":142,"type":20},"2028-04-01",{"name":37,"class":38},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":5},"100596427","phase-2-js207-combination-therapy-in-triple-negative-breast-cancer-100596427","NCT07045311","JS207 Combination Therapy in Triple-negative Breast Cancer","JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)","Inclusion Criteria:\n\n1. Male or female age 18 - 75 years old；\n2. Voluntary participation in clinical study；\n3. Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);\n4. No prior systemic antitumor therapy for locally advanced or Metastatic TNBC；\n5. Prior use of systemic anti-tumor therapy in the neoadjuvant and\u002For adjuvant phase is allowed, but must meet the following conditions: (1) the time interval between the end of neoadjuvant\u002Fadjuvant therapy and the occurrence of recurrence\u002Fmetastasis is ≥6 months; (2) Arm2: if taxane is used in the neoadjuvant\u002Fadjuvant phase, the DFI must be ≥12 months;\n6. Adequate organ function;\n7. ECOG performance status of 0 or 1;\n8. Life expectancy 12 weeks;\n9. Measurable disease, as defined by RECIST v1.1;\n\nExclusion Criteria:\n\n1. Untreated or active central nervous system (CNS) metastases；\n2. Uncontrolled pleural effusion, pericardial effusion or ascites；\n3. Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage；\n4. History of significant bleeding tendency or severe coagulation disorder；\n5. Uncontrolled hypertension；\n6. Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose；\n7. History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period；\n8. Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；\n9. Severe cardiovascular disease；\n10. Serious infection (CTCAE 5.0 Grade\\>2) within 28 days prior to the first dose of study drug；\n11. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting other stimulatory or co-inhibitory T cell receptors (e.g., CTLA-4, OX-40, CD137) in (new) adjuvant therapy is allowed, if DFI is ≥6 months previously treated with Antibody-Drug Conjugates conjugated with MMAE and\u002For targeting Nectin-4, such as Enfortumab Vedotin is not allowed；\n12. History of another malignancy within 5 years before the first dose of study drug；\n13. Not suitable to receive study treatment for other conditions as per investigator；",{"count":110,"type":20},[51],"This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC.",[155],"Triple-negative Breast Cancer","2026-04-10",{"date":158,"type":31},"2026-04-15",{"date":160,"type":31},"2025-09-17",{"date":162,"type":20},"2029-03-22",{"name":37,"class":38},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":177,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100632782","phase-2-js212-plus-js111-in-egfr-mutant-advanced-nsclc-a-phase-ii-study-100632782","NCT07518160","JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study","A Phase II Study of JS212 in Combination With JS111 in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for this study:\n\n1. Age between 18 and 75 years (inclusive) at the time of signing the informed consent form (ICF), regardless of sex;\n2. Histologically or cytologically confirmed recurrent or metastatic non-squamous NSCLC that is unresectable and not amenable to curative chemoradiotherapy;\n3. Confirmed EGFR-sensitizing mutation, including:\n\n   Exon 19 deletion or L858R mutation,Either alone or in combination with other EGFR mutations, Including those with concurrent T790M mutation positivity.Local laboratory reports are acceptable, provided that the test method is well-validated, or has passed external quality assessment (EQA), or is conducted by a certified molecular pathology\u002Fgenetic testing laboratory, or is approved by NMPA;\n4. Prior treatment with:\n\n   EGFR-TKIs, and If applicable, ≤1 line of platinum-based doublet chemotherapy, with radiologically confirmed disease progression per RECIST v1.1;\n5. At least one measurable lesion per RECIST v1.1;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n7. Estimated life expectancy of ≥12 weeks;\n8. Adequate organ function meeting the following criteria (Note: No blood transfusion or hematopoietic growth factors are allowed within 14 days prior to screening assessments):\n\n   1. Absolute neutrophil count ≥1.5 × 10⁹\u002FL;\n   2. Platelet count ≥100 × 10⁹\u002FL;\n   3. Hemoglobin ≥90 g\u002FL (≥9 g\u002FdL);\n   4. ALT and AST ≤2.5 × ULN (≤5 × ULN in case of liver metastases);\n   5. Total bilirubin ≤1.5 × ULN;\n   6. Creatinine clearance ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n   7. Activated partial thromboplastin time (APTT) ≤1.5 × ULN and international normalized ratio (INR) ≤1.5(patients on stable anticoagulant therapy such as low molecular weight heparin or warfarin are allowed if INR is within the therapeutic range);\n9. Female participants of childbearing potential (WOCBP) who are sexually active with non-sterilized male partners must:\n\n   Have a negative serum pregnancy test within 7 days prior to first dose, and Agree to highly effective contraception and have no plans for pregnancy from signing the ICF until: 7 months after the last dose of JS212, and 2 months after the last dose of JS111, whichever period is longer (definition of WOCBP is provided in Section 10.3);\n10. Non-sterilized male participants who are sexually active with women of childbearing potential must: Agree to use effective contraception as described in Section 10.3.2 from signing the ICF until 4 months after the last dose of JS212 or JS111, and Refrain from sperm donation during this period;\n11. Participants must voluntarily participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Disease-related conditions:\n\n   a. Histologically or cytologically confirmed presence of: Small cell lung cancer component, or Large cell neuroendocrine carcinoma, or Sarcomatoid features, or Squamous component \\>10%; b. Known leptomeningeal metastases; c. Symptomatic brain metastases; Asymptomatic brain metastases may be eligible if assessed as stable by the investigator, including: i. Previously treated brain metastases (e.g., radiotherapy) that are stable, defined as: No CNS-related symptoms,Discontinuation of corticosteroids and osmotic agents (e.g., mannitol) ≥7 days prior to first dose, No radiographic progression compared with pre-treatment imaging (interval ≥4 weeks); ii. Untreated asymptomatic brain metastases meeting all of the following: No use of corticosteroids or osmotic agents,No lesion with longest diameter ≥1 cm, No metastases in midbrain, pons, medulla, or spinal cord, No history of intracranial hemorrhage; d. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (≥ once per month); e. Untreated spinal cord compression, or previously treated spinal cord compression without evidence of stability for ≥4 weeks prior to enrollment;\n2. Prior\u002Fconcomitant treatments:\n\n   1. Within: 4 weeks or 5 half-lives (whichever is shorter) prior to first dose: chemotherapy or similar therapies;7 days: small molecule targeted therapy; 2 weeks: localized radiotherapy (e.g., palliative radiation for bone metastases);\n   2. Use of strong CYP3A inhibitors or inducers within 14 days prior to first dose or requirement for continued use during study;\n   3. Current use or requirement for use of medications known to prolong QT interval or cause torsades de pointes;\n   4. Receipt of any investigational drug within 4 weeks or 5 half-lives prior to first dose (whichever is shorter);\n   5. Participation in another clinical trial, unless it is: Observational (non-interventional), or The participant is in the follow-up phase of an interventional study;\n   6. Major surgery (e.g., craniotomy, thoracotomy, laparotomy) within 4 weeks prior to first dose;\n3. Toxicity Unresolved toxicities from prior anti-tumor therapy that have not recovered to:\n\n   ≤ CTCAE Grade 1, or The level specified in inclusion\u002Fexclusion criteria,whichever is more severe (Grade 2 toxicities deemed not clinically significant by the investigator, such as alopecia, chemotherapy-induced neuropathy, or hypothyroidism, are allowed);\n4. Hypersensitivity Known allergy or hypersensitivity to any study drug or its excipients;\n5. Cardiac conditions:\n\n   1. QTcF:≥450 ms (male), ≥470 ms (female), averaged from 3 ECG measurements;\n   2. Clinically significant arrhythmias, including but not limited to:Complete left bundle branch block,Third-degree AV block,Second-degree AV block,PR interval \\>250 ms;\n   3. Risk factors for torsades de pointes, such as: Clinically significant hypokalemia,Family history of long QT syndrome or arrhythmias;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n6. Gastrointestinal conditions Conditions affecting drug absorption, distribution, metabolism, or excretion, such as: Inability to swallow oral medication, Persistent vomiting,Uncontrolled diarrhea,Extensive gastrointestinal resection,Crohn's disease, ulcerative colitis;\n7. Pulmonary conditions History of or suspected: Interstitial lung disease, Drug-induced pneumonitis,Idiopathic pneumonitis,Idiopathic pulmonary fibrosis,or other significant pulmonary disease (≤Grade 1 radiation pneumonitis is allowed);\n8. Ocular conditions Severe or uncontrolled ocular disorders that may increase risk, including:\n\n   Severe dry eye syndrome,Keratoconjunctivitis sicca,Severe exposure keratitis, or other conditions predisposing to epithelial damage;or requiring surgery during the study (non-urgent cataract is allowed);\n9. Infection Severe infection (CTCAE ≥ Grade 3) within 4 weeks prior to first dose; Evidence of active pulmonary inflammation on imaging at baseline; Infection requiring systemic antibiotics within 2 weeks prior to first dose (excluding prophylactic use);\n10. Immunodeficiency History of immunodeficiency, including HIV positivity;Other acquired or congenital immunodeficiency;History of organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;\n11. Tuberculosis Active tuberculosis, or History of active tuberculosis within 1 year prior to enrollment, or History of active tuberculosis \\>1 year ago without adequate treatment;\n12. Viral hepatitis Active HBV infection: HBsAg positive with HBV DNA ≥1000 copies\u002FmL or ≥200 IU\u002FmL; Active HCV infection: HCV antibody positive with detectable HCV RNA above LLOQ;\n13. Other malignancies Any other malignancy requiring treatment within 5 years prior to first dose, except: Malignancies with low metastatic risk and \\>90% 5-year survival, such as: Adequately treated basal or squamous cell skin cancer, Carcinoma in situ of cervix or breast, Localized prostate cancer, Papillary thyroid carcinoma;\n14. Pregnancy and lactation Pregnant or breastfeeding women, or those planning pregnancy during the study;\n15. Uncontrolled comorbidities Including but not limited to: Symptomatic congestive heart failure within 6 months, Uncontrolled hypertension, Unstable angina, Uncontrolled arrhythmia, Major seizure disorders,Superior vena cava syndrome,Aortic aneurysm requiring surgery, Arterial thromboembolism,≥Grade 3 venous thromboembolism (CTCAE v6.0),Stroke or transient ischemic attack; or psychiatric\u002Fsocial conditions that may affect compliance or informed consent;\n16. Investigator judgment Any condition that, in the investigator's opinion, may: Lead to premature discontinuation,Compromise patient safety, or Affect data integrity, including abnormal laboratory values or unfavorable social\u002Ffamily circumstances.",{"count":172,"type":20},35,[51],"This is a Phase II study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212 in combination with JS111 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who have progressed after prior EGFR-TKI therapy.\n\nThe study consists of two parts: a dose-escalation phase followed by an expansion phase. Approximately 30 participants will be enrolled. The dose-escalation phase will explore the safety and tolerability of escalating doses of JS212 in combination with a fixed dose of JS111, using a Bayesian optimal interval (BOIN) design. Based on safety and tolerability data, a recommended Phase III dose (RP3D) will be determined. The expansion phase will further evaluate safety and preliminary anti-tumor activity at the selected dose level.",[176],"Locally Advanced, Metastatic, or Recurrent Non-small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR) Mutations","NOT_YET_RECRUITING","2026-04-01",{"date":180,"type":31},"2026-04-08",{"date":182,"type":20},"2026-03-23",{"date":184,"type":20},"2029-04-23",{"name":37,"class":38},2,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100587147","phase-2-evaluating-the-preliminary-efficacy-and-safety-of-js207-in-nsclc-after-progression-following-platinum-based-chemotherapy-and-immunotherapy-100587147","NCT06924606","Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy","A Phase II Study of JS207 (PD-1\u002FVEGF Dual Antibody) in Combination With or Without JS004 or Docetaxel in Advanced Non-small Cell Lung Cancer With Disease Progression During or After the Treatment of Platinum-based Chemotherapy and Immunotherapy","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (stage IIIB\u002FIIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.\n2. Subjects with unresectable locally advanced or metastatic or recurrent NSCLC who have failed first-line treatment with PD-1\u002FPD-L1 inhibitors combined with platinum-based doublet chemotherapy (excluding docetaxel); or who have failed sequential first- and second-line treatment with PD-1\u002FPD-L1 inhibitors followed by platinum-based doublet chemotherapy (excluding docetaxel).\n3. Subjects must have at least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.\n2. Sensitivity mutation of EGFR or ALK fusion.\n3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.",{"count":195,"type":20},66,[51],"This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.",[199],"Advanced NSCLC","2026-02-04",{"date":202,"type":31},"2026-02-06",{"date":204,"type":31},"2025-07-15",{"date":206,"type":20},"2026-06-26",{"name":37,"class":38},18,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100614787","phase-3-js107-vs-investigators-choice-as-second-line-or-later-therapy-for-advanced-cldn182-positive-gastricor-gej-adenocarcinoma-100614787","NCT07284134","JS107 vs Investigator's Choice as Second-line or Later Therapy for Advanced CLDN18.2-Positive Gastricor GEJ Adenocarcinoma.","Inclusion Criteria:\n\n1. Voluntarily participate in this study, have ICF signed after sufficient informed consent, and have good compliance.\n2. Age ≥ 18 years, male or female.\n3. ECOG PS 0 or 1.\n4. Expected survival period≥ 3 months.\n5. Patients with HER2 negative G\u002FGEJ adenocarcinoma confirmed by histology\u002Fcytology.\n6. Patients who have received at least one prior line of systemic treatments and developed PD, and the previous treatment must include fluorouracil and platinum.\n7. Fresh or archival tumor tissue (blocks of formalin-fixed, paraffin-embedded \\[FFPE\\] tissue or unstained FFPE tumor tissue sections) must be available and comfirmed CLDN18.2 positivity by for central laboratory through immunohistochemistry (IHC) before randomization.\n8. Having ≥ 1 measurable lesion according to RECIST v1.1 (per investigator assessment).\n9. Any AEs and\u002For complications caused by previous therapies including surgery or radiotherapy have been adequately resolved to Grade 0 or 1 (per NCI-CTCAE v5.0 criteria) or have been stabilized in the judgment of investigators.\n\nExclusion Criteria:\n\n1. Previous treatment with any drug or cellular therapy targeting CLDN18.2 (except CLDN18.2 monotarget monoclonal antibody).\n2. Previously treated with an ADC loaded with a tubulin inhibitor.\n3. Received strong CYP3A inhibitor or inducer within 2 weeks or 5 half-lives prior to randomization, whichever is longer.\n4. Use of chemotherapy, immunotherapy or other anti-tumor therapies or participation in other clinical trials within 3 weeks prior to randomization, or use of oral fluorouracil, small molecule targeted drugs or traditional Chinese medicine for gastric cancer within 2 weeks prior to randomization.\n5. Major surgery (requiring general anaesthesia and \\>24 hours of Hospitalisation) or other clincal trial drug treatment within 4 weeks prior to randomization, or radiotherapy within 2 weeks prior to randomization.\n6. Imaging demonstrating brain metastases (except patients who have completed whole brain radiotherapy or local therapy (such as surgery), have discontinued prednisone for at least 4 weeks prior to randomization, and have stable radiologically confirmed tumor lesions and no clinical symptoms of tumor during 4 weeks prior to randomization), metastases to meninges, or spinal cord compression.\n7. Tumor invades important surrounding structures (e.g., large blood vessels, trachea, etc.) with high risk of rupture and hemorrhage or airway fistula, or metastases to bone with high risk of paraplegia.\n8. Thromboembolic events within 3 months prior to randomization (except patients with non-pulmonary Thromboembolism who do not require treatment or have been stably treated with anticoagulants for 14 days or longer prior to randomization).\n9. History of other neoplasm malignant within 5 years prior to randomization, except for neoplasm malignant cured after treatment.\n10. Having active autoimmune diseases requiring systemic treatment (i.e., immunologic modulator, corticosteroid, or Immunosuppression) within 2 years prior to randomization; replacement therapy (such as thyroid hormone, Insulin, or physiologic corticosteroid replacement therapy due to adrenal or pituitary insufficiency) is not considered systemic treatment.\n11. Known severe allergic reaction to any component in the investigational drug formula.",{"count":216,"type":20},560,[218],"PHASE3","This is a multicenter, randomized, controlled, open-label, Phase III study, designed to evaluate the efficacy and safety of JS107 versus investigator-selected therapy in the second-line or later treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma positive for CLDN18.2.\n\nThe study population consists of patients with CLDN18.2-positive, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have received at least one prior line of systemic therapy. The primary endpoints of the study are BICR-assessed progression-free survival and overall survival.\n\nNumber of subjects and allocation:This study plans to enroll approximately 560 subjects, who will be randomized in a 1:1 ratio to receive either JS107 (experimental group) or investigator-selected therapy (control group).",[221],"Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","2026-01-21",{"date":224,"type":31},"2026-01-22",{"date":226,"type":31},"2025-12-24",{"date":228,"type":20},"2028-10-17",{"name":37,"class":38},68,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":63},"100599171","phase-2-js203-combination-regimens-in-b-cell-non-hodgkins-lymphoma-100599171","NCT07081022","JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be enrolled：\n\n* Age range: 18 to 80 years old (inclusive), both male and female are acceptable；\n* ECOG: 0-2；\n* B-cell non-Hodgkin's lymphoma expressing CD20 antigen that has been pathologically diagnosed；\n* At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment； Acceptable organ function at screening；\n\nExclusion Criteria:\n\n* A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；\n* Previously received CD20-CD3 bispecific antibody treatment；\n* Previous allogeneic hematopoietic stem cell transplantation；\n* Previous solid organ transplantation；\n* History of autoimmune diseases；\n* Patients with a history of macrophage activation syndrome (MAS)\u002F hemophagocytic lymphohistiocytosis (HLH)；\n* Patients with a history of progressive multifocal leukoencephalopathy (PML)；\n* A known or suspected history of CNS lymphoma (including primary or secondary)；\n* There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)；","80 Years",{"count":239,"type":20},180,[51],"To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma",[243],"B-cell Non-Hodgkin's Lymphoma","2025-08-20",{"date":246,"type":31},"2025-08-21",{"date":248,"type":31},"2025-08-17",{"date":250,"type":20},"2027-04-06",{"name":37,"class":38},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":63},"100590562","phase-2-js207combined-with-chemotherapy-in-first-line-treatment-of-advanced-nsclc-100590562","NCT06969027","JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC","JS207 (PD-1\u002FVEGF Dual Antibody) Combined With Chemotherapy in First-line Treatment of Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.\n2. Locally advanced (stage IIIB\u002FIIIC), metastatic or recurrent non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.\n3. History of no systemic antitumor therapy for Metastatic or recurrent NSCLC; for subjects who have received adjuvant\u002Fneoadjuvant\u002Fconsolidation therapy (Chemotherapy, radiotherapy, or other therapy), they can be enrolled if the interval between the last treatment and recurrence is more than 6 months.\n4. Tissue samples are required for PD-L1 test. New tissue samples are preferred. If new tissue samples are not available, archived samples can be provided.\n5. According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.\n6. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.\n7. Expected survival period ≥ 12 weeks.\n8. The function of important organs meets the requirements of the protocol.\n9. Female subjects of childbearing potential, and male subjects whose partners are females of childbearing age, need to adopt a highly effective contraceptive measure during the study treatment period and for at least 6 months after the last administration.\n10. Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.\n\nExclusion Criteria:\n\n1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer and large cell neuroendocrine carcinoma) components.\n2. Treatment received as listed in the protocol, including immunologically mediated treatment; drugs targeting the anti-VEGF pathway, etc.\n3. Having an obvious bleeding tendency or a history of severe coagulation dysfunction.\n4. Gastrointestinal perforation, intra-abdominal fistula or intra-abdominal abscess occurred within 6 months before the first administration, or currently having high-risk factors for perforation\u002Ffistula formation of the hollow viscus as judged by the investigator.\n5. Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.\n6. Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.\n7. Expected that the toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE).\n8. Known allergy to the investigational drug or its excipients, pemetrexed, platinum drugs (carboplatin\u002Fcisplatin), or known history of ≥ grade 3 allergy to antibody drugs",{"count":260,"type":20},84,[51],"This study targets patients with in first-line treatment of advanced NSCLC， enrolling 60-84 participants. Patients will receive Arm 1: JS207 (10 mg\u002Fkg or 15 mg\u002Fkg, IV, D1) + Pemetrexed (500 mg\u002Fm2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg\u002Fm2, D1), Q3W, for 4 cycles followed by JS207 (10 mg\u002Fkg or 15 mg\u002Fkg, IV, D1) + pemetrexed (500 mg\u002Fm2 IV, D1), Q3W, until meeting the treatment withdrawal criteria. Arm 2: JS207 (10 mg\u002Fkg or 15 mg\u002Fkg, IV, D1) + Paclitaxel (175 mg\u002Fm2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg\u002Fm2, D1), Q3W, for 4 cycles followed by JS207 (10 mg\u002Fkg or 15 mg\u002Fkg, IV, D1), Q3W, until meeting the treatment withdrawal criteria.The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.",[264],"Non-small Cell Lung Cancer","2025-07-02",{"date":267,"type":31},"2025-07-04",{"date":269,"type":31},"2025-06-19",{"date":271,"type":20},"2027-12-31",{"name":37,"class":38},{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":21,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},"100589442","phase-2-js207-combined-with-js007-as-first-line-treatment-for-advanced-hepatocellular-carcinoma-100589442","NCT06954467","JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma","A Phase II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of JS207 Combined With JS007 as First-line Treatment for Advanced Hepatocellular Carcinoma（HCC）","Inclusion Criteria:\n\n1. Willing to participate and sign a written informed consent form.\n2. Age ≥ 18 years, male or female.\n3. Patients with histologically\u002Fcytologically confirmed HCC or Hepatic cirrhosis meeting the criteria of the American Association for the Study of Liver Diseases (AASLD) can be enrolled.\n4. HCC classified as Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage) or stage C (advanced stage), or stage IIa\u002FIIb or IIIa\u002FIIIb as defined by the Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition), prior to lymph node clearance, and deemed unsuitable for surgical and\u002For local treatment.\n5. No systemic therapy for HCC prior to study entry (mainly including systemic chemotherapy, targeted therapy, immunotherapy, etc.; adjuvant\u002Fneoadjuvant administration of small molecule anti-angiogenic drugs, such as lenvatinib, sorafenib, and donafenib, is allowed, but the last dose of these drugs must be administered ≥90 days prior to the first dose of the study drug).\n6. Having ≥1 measurable lesion according to RECIST v1.1. Requirement: The selected target lesion had not been subjected to local therapy previously, or the selected target lesion was located in the area of previous local therapy, but later determined to be progressed through imaging examination according to RECIST v1.1.\n7. Child-Pugh liver function class A or B ≤ 7 without history of Hepatic encephalopathy.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n9. Life expectancy ≥12 weeks.\n10. Major organ function meets the following requirements, without transfusion, hematopoietic stimulating factors (including G-CSF, GM-CSF, EPO and TPO, etc.) or human Albumin preparations within 14 days prior to screening:\n11. Females of childbearing potential and males whose partners are of childbearing age are required to use highly effective contraceptive measures during the trial and for at least 6 months after the last dose (Appendix 5). Female patients of childbearing potential must have a negative serum HCG test within 7 days before study entry and must be non-lactating.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria should be excluded from this study:\n\n1. Received major surgery (requiring general anesthesia and \\>24 hours of hospitalization, excluding diagnostic biopsy), live vaccination, or investigational drug treatment within 4 weeks prior to the first dose, or received palliative radiotherapy for localized bone\u002Fbrain lesions within 2 weeks prior to the first dose.\n2. Patients who are receiving chronic systemic corticosteroid therapy (daily dose \\>10 mg prednisone or other glucocorticoid with the same effect) or other immunosuppression therapy within 7 days prior to the first dose.\n3. Hepatic tumor burden \\> 50% of total hepatic volume at screening.\n4. Invasion of portal vein main trunk (Vp4) by cancer thrombus (more than 1\u002F2 of lumen) as confirmed by CT\u002FMRI examination.\n5. Presence of metastases to central nervous system of HCC; MRI scan of brain and\u002For spine is required to rule out the possibility when it is suspected.\n6. Toxicity induced by previous treatment (except for alopecia and Neuropathy peripheral) has not recovered to ≤ grade 1 (NCI-CTCAE v5.0).\n7. Severe infection during the screening period, including but not limited to hospitalization for infection, bacteraemia or severe pneumonia complications, oral or intravenous administration of therapeutic antibiotics for ≥7 days within 14 days prior to the first dose (patients receiving prophylactic antibiotics can be enrolled), fever ≥38.5°C of unknown origin within 7 days prior to the first dose or white blood cell count \\>15×109\u002FL at baseline.\n8. Uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically evident moderate or severe peritoneal effusion during screening period is defined as meeting the following criteria: having clinical symptoms and detectable pericardial, pleural, and peritoneal effusion on physical examination; or pleural and peritoneal effusion requiring puncture and aspiration and\u002For intracavitary drug administration for treatment.\n9. Grade ≥3 (NCI-CTCAE v5.0) gastrointestinal or non-gastrointestinal fistula during screening period.\n10. Existence of severe unhealed wounds, active ulcer and Therapy naive fracture at screening period.\n11. Severe cardiovascular diseases.\n12. History of haemorrhage of digestive tract within 6 months prior to the first dose, or clear haemorrhagic diathesis (including high-risk severe esophageal-gastric varicose vein, local active digestive tract ulcer lesions, and persistent faecal occult blood positive; if faecal occult blood positive at baseline, it can be rechecked; if still positive after recheck, upper gastrointestinal endoscopy is required; if endoscopy indicates severe esophageal-gastric varicose vein or the investigator judges that there is a clear risk of bleeding, then the subject cannot be enrolled).\n13. Evidence of other haemorrhagic diathesis or significant coagulopathy.\n14. History of intestinal obstruction and\u002For clinical signs or symptoms of gastrointestinal tract obstruction within 6 months prior to the first dose, including incomplete obstruction associated with pre-existing diseases requiring routine parenteral hydration, parenteral nutrition, or enteral feeding (patients who received definite \\[surgical\\] treatment prior to the first dose to resolve the obstruction symptoms were allowed to be enrolled).\n15. Active autoimmune disorders requiring systemic treatment within 2 years prior to the first dose; however, replacement therapy (e.g., Thyroxine, Insulin, or physiological replacement of corticosteroids for adrenal or Pituitary insufficiency) will not be considered as systemic treatment and is allowed.\n16. Having had neoplasm malignant (except HCC) within 5 years prior to the first dose, including mixed type of liver cancer; however, localized tumors that have been cured, including Carcinoma cervix in situ, Basal cell carcinoma, and Carcinoma in situ of prostate, etc.\n17. History of interstitial lung disease or noninfectious pneumonitis, unless caused by local radiotherapy.\n18. Patients with active tuberculosis or who have received anti-tuberculosis therapy within one year prior to the first dose.\n19. HBV and\u002For HCV infection: a) HBsAg (+) and\u002For HBcAb (+), and HBV DNA \\> 1000 IU\u002FmL (if the lower limit of the minimum measurable value of the local center is higher than 1000 IU\u002FmL, enrollment will be decided according to the specific circumstances after discussion with the sponsor; the patient must continue to receive the original anti-HBV therapy throughout the study, or start the entecavir or tenofovir throughout the study after screening); b) positive HCV Antibody and HCV RNA \\> upper limit of normal; c) co-infection with hepatitis B and C.\n20. Known history of human immunodeficiency virus (HIV) infection, prior allogeneic stem cell or Solid organ transplant, or other Immunodeficiency.\n21. Known severe allergy to any Monoclonal antibodies.\n22. Other factors that may affect the study results or cause the study to be terminated prematurely, as judged by the investigator, such as alcoholism, Drug of Abuse, other serious diseases (including mental disorders), need for concomitant treatment, serious Laboratory test abnormal, and family or social factors that may affect the patient's safety.",{"count":281,"type":20},72,[51],"This open-label, multicenter phase II study was designed to evaluate the safety and efficacy of JS207 alone or in combination with JS007 as first-line treatment in subjects with advanced HCC.\n\nThe subjects were all subjects with unresectable, locally advanced, recurrent, or metastatic HCC who had not received previous systemic therapy. Planned to enroll 43 to 72 subjects.The study was divided into two stages, dose exploration stage (3-12 cases) and random expansion stage (40-60 cases).After the dose exploration phase, a dose group was selected to enter the randomized expansion phase based on comprehensive discussion and evaluation of DLT, AE, dose adjustment, PK parameters and preliminary efficacy results in each dose group.",[285],"Hepatocellular Carcinoma","2025-07-01",{"date":265,"type":31},{"date":289,"type":31},"2025-05-29",{"date":291,"type":20},"2028-06-30",{"name":37,"class":38},12,{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":301,"targetDuration":4,"studyType":21,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":186},"100584134","phase-2-a-phase-2-study-evaluating-the-safety-and-efficacy-of-js207-with-or-without-js015-in-combination-with-chemotherapy-in-patients-with-colorectal-cancer-100584134","NCT06885385","A Phase 2 Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy in Patients With Colorectal Cancer","An Open-label, Multicenter, Phase 2 Clinical Study Evaluating the Safety and Efficacy of JS207 With or Without JS015 in Combination With Chemotherapy (XELOX) as First-line (1L) Treatment in Patients With MSS\u002FpMMR Advanced Colorectal Cance","Inclusion Criteria:\n\n1. Subjects aged 18 to 75 (inclusive) at the time of signing the consent form, both male and female\n2. Colorectal adenocarcinoma or rectal adenocarcinoma with histological or cytological Qualification, according to the 8th edition of the AJCC colorectal cancer TNM staging stage IV, MSS\u002FpMMR (a qualified report of MSS or pMMR detected by a local laboratory must be provided), and no previous systemic anti-tumor therapy for advanced disease; for patients who have received neoadjuvant or adjuvant systemic therapy, the last treatment to relapse or progression takes more than 12 months\n3. ECOG score is 0 or 1\n4. Estimated survival ≥ 12 weeks\n5. According to the RECIST v1.1 evaluation standard, there is at least one measurable lesion\n6. Good organ function\n7. Female or male subjects with fertility must agree to have no family planning during the study period and voluntarily use effective contraception with significant others within 6 months after the end of the last medication. Female subjects with fertility (WOCBP) must have a negative serum pregnancy test within 7 days before the first medication and be non-lactating (see section 10.3 for specific contraceptive measures and WOCBP definitions)\n8. The patient participated voluntarily, gave full informed consent, signed a written ICF, and had good compliance\n\nExclusion Criteria:\n\n1. Previously received PD-1 or programmed cell death ligand 1 (PD-L1) inhibitor therapy; or previously received DKK1 inhibitor therapy (only for cohort 2 subjects)\n2. Received the following medications or treatments before the first dose Within 28 days before the first dose, major surgery and radiotherapy (palliative radiotherapy for local bone\u002Fbrain lesions, allowed to be completed within 14 days before the first dose) were performed. Within 7 days before the start of the study, coarse needle aspiration biopsy or other minor surgery was performed, excluding the placement of vascular infusion devices.\n\n   Within 14 days before the first medication, antiplatelet therapy such as aspirin (≥ 325 mg\u002Fday), clopidogrel (≥ 75 mg\u002Fday), or anticoagulant therapy for therapeutic purposes have been used.\n\n   Patients who have received systematic treatment with corticosteroids (\\> 10 mg prednisone or equivalent dose per day) or other immunosuppressants for more than 1 week before the first dose are allowed to use inhaled or topical steroids or ≤ 10 mg\u002Fday systemic prednisone and equivalent doses of similar drugs for treatment.\n\n   D) Have received any live vaccine or attenuated live vaccine within 28 days before the first dose, or expect to receive live vaccine or attenuated live vaccine during the study period (limited to patients in combination therapy studies);\n3. The toxicity of previous anti-tumor treatment has not been restored to the level specified in CTCAE v5.0 or the level specified in the inclusion\u002Fexclusion criteria, except for the following cases: the relevant toxicity that has been judged by the investigator to be well controlled and does not affect the safety and compliance of the patient with the study drug can be screened after qualification with the sponsor\n4. Digestive tract perforation, fistula, abdominal abscess, and digestive system ulcerative diseases or a history thereof within 6 months prior to the first medication (the investigator may consider inclusion if the ulcer condition is stable)\n5. There are pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms that require repeated treatment (puncture or drainage, etc.)\n6. History of interstitial lung disease or previous history of non-infectious pneumonia treated with corticosteroids, or evidence of active pneumonia on screening imaging\n7. Severe, unhealed or open wounds, active ulcers, or untreated fractures (excluding old fractures evaluated by researchers as not requiring clinical intervention)\n8. Evidence of obvious bleeding tendency or severe coagulation dysfunction,Have a history of gastrointestinal bleeding within the 6 months prior to enrollment, or have a clear tendency towards gastrointestinal bleeding (including severe esophageal-gastric varices with bleeding risk, locally active gastrointestinal ulcer lesions, and persistent positive fecal occult blood),Clinically significant hemoptysis or tumor bleeding for any reason within 28 days before the first medication.Screening period imaging shows that the tumor surrounds important blood vessels or has obvious necrosis and cavities, and the researchers believe that it may cause bleeding risks\n9. Presence of poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy\n10. Severe cardiovascular and cerebrovascular diseases, including but not limited to: myocardial infarction, severe\u002Funstable angina pectoris, congestive heart failure (New York Heart Association \\[NYHA\\] heart function classification ≥ 2), clinically significant supraventricular or ventricular arrhythmia requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis\u002Fembolism events, grade 3 or above (CTCAE v5.0) venous thrombosis\u002Fembolism events, transient cerebral ischemic attack, cerebrovascular accident; left ventricular ejection fraction (LVEF) \\\u003C 50% in cardiac ultrasound examination. The corrected QT interval (QTc) is \\> 480 ms (calculated using the Fridericia method. If the QTc is abnormal, it can be detected three times continuously every 2 minutes and the average value is taken)\n11. There is active Central Nervous System metastasis. If the patient has received radiotherapy or surgery in the past, the imaging examination within 4 weeks before the first medication shows that the brain metastasis is stable and there is no aggravation or new neurological symptoms. Hormonal therapy has been stopped two weeks before the first medication, and screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, screening is not allowed regardless of treatment\n12. Severe infection (CTCAE v5.0 \\> 2) occurred within 28 days before the first study administration, such as severe pneumonia, bacteremia, and comorbidities requiring hospitalization; or active infection requiring systemic anti-infective treatment or fever of unknown cause \\> 38.5 ℃ occurred within 2 weeks before the first study administration (according to the investigator's judgment, subjects with fever caused by tumors can be enrolled);\n13. Active tuberculosis, hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive and HBV DNA higher than 1000 copies\u002Fml or 200 IU\u002Fml), hepatitis C (hepatitis C antibody \\[HCVAb\\] positive and HCV RNA higher than the lower limit of the research center)\n14. Have a history of immunodeficiency diseases, including a positive test for human immunodeficiency virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n15. Active autoimmune diseases that require systemic treatment (e.g. corticosteroids or immunosuppressive drugs) within 2 years before the first medication, including but not limited to: systemic systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, thyroid, adrenal or pituitary gland dysfunction that can be controlled only with hormone replacement therapy, type 1 diabetes, psoriasis or vitiligo that do not require systemic treatment, childhood asthma\u002Fallergies that have been cured are allowed to be screened\n16. Have a history of another primary malignant tumor, except for malignant tumors (such as basal cell carcinoma and squamous cell carcinoma of the skin that have received potential curative treatment) that have received radical treatment before the first dose of the study intervention and have no known active disease (more than 5 years) and low potential recurrence risk\n17. Patients who have other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, affect treatment adherence, or interfere with the study results, and are judged by the investigator to be unsuitable for participation in this study",{"count":302,"type":20},60,[51],"This study is an open label, multicenter Phase II clinical trial aimed at evaluating the safety and efficacy of JS207 with or without JS015 in combination with chemotherapy (XELOX) as a first-line treatment for advanced colorectal cancer with MSS\u002FpMMR. The study was divided into two cohorts: Cohort 1 was JS207 combined with XELOX, and Cohort 2 was JS207 combined with JS015 and XELOX.",[306],"Advanced Colorectal Cancer","2025-06-17",{"date":309,"type":31},"2025-06-24",{"date":311,"type":31},"2025-04-23",{"date":313,"type":20},"2027-02-13",{"name":37,"class":38},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":63},"100584399","phase-1-a-phase-iii-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-initial-efficacy-of-js212-in-subjects-with-advanced-malignant-solid-tumour-100584399","NCT06888830","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour","Inclusion Criteria:\n\n1. Subjects of either sex who are 18 to 75 years of age (inclusive of 18 and 75 years) at the time of signing the consent form;\n2. Histologically or cytologically confirmed advanced malignant solid tumors;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n4. Expected survival of ≥ 12 weeks;\n5. Subjects have at least 1 measurable lesion according to RECIST v1.1 criteria (without measurable lesions are allowed during dose escalation phase);\n\nExclusion Criteria:\n\n1. Presence of active central nervous system metastasis. If previous radiotherapy or surgery, etc. has been received, and the imaging examination within 4 weeks before the first dose suggests that the brain metastasis is stable without exacerbation or new neurological symptoms, and hormone therapy has been discontinued two weeks before the first dose, screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, regardless of the treatment or not, screening is not allowed;\n2. Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion that requires repeated management (puncture or drainage, etc.);\n3. Presence of medically uncontrolled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;\n4. Presence of a history of (non-infectious) interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy (e.g., idiopathic pulmonary fibrosis, mechanized pneumonia, drug-induced pneumonia, radiation pneumonitis, idiopathic pneumonia, etc.), and current ILD\u002Fnon-infectious pneumonia;\n5. Presence of clinically significant lung-specific co-morbidities including, but not limited to, any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, etc., diagnosed within 3 months prior to the first study dose) and any autoimmune, connective tissue, or inflammatory disease with pulmonary involvement (e.g., rheumatoid arthritis, Scheugelin's syndrome, sarcoidosis, etc.) and prior total pneumonectomy;\n6. Presence of a history of immunodeficiency, including a positive test for Human Immunodeficiency Virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation；\n7. the presence of other factors that may cause them to be forced to terminate the study midway, such as serious physical or mental illness or abnormal laboratory tests, which may increase the risk of participation in the study, affect treatment compliance, or interfere with the results of the study, and which, in the judgment of the investigator, make the subject unsuitable for participation in this study；",{"count":322,"type":20},374,[23,51],"This study is a Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.",[326],"Advanced Malignant Solid Tumours",{"date":269,"type":31},{"date":329,"type":31},"2025-04-11",{"date":331,"type":20},"2027-04-01",{"name":37,"class":38},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":340,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":177,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":63},"100588674","phase-2-js207-combined-with-chemotherapy-in-subjects-with-stage-ii-iii-nsclc-100588674","NCT06944470","JS207 Combined With Chemotherapy in Subjects With Stage II-III NSCLC","JS207 (Anti-PD-1\u002FVEGF Bispecific Antibody) Combined With Platinum-based Doublet Chemotherapy in Subjects With Stage II-III Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age 18 to 75 years at the time of signing the informed consent (inclusive of 18 and 75 years), either gender.\n2. Histologically confirmed, previously untreated stage II-III NSCLC (AJCC 8th edition), cTNM stage can be confirmed by PET-CT or pathological biopsy. For suspicious lesions that are suspected by imaging examination, which can lead to changes in TNM stage, including but not limited to contralateral mediastinal lymph nodes and supraclavicular lymph nodes, pathological biopsy verification is strongly recommended.\n\n   1. Cohort 1: Subjects with resectable, stage II, IIIA, or IIIB (N2) NSCLC evaluated by MDT.\n   2. Cohort 2: Subjects with unresectable, stage III NSCLC evaluated by MDT.\n3. Total lung function can withstand the proposed lung resection procedure according to the surgeon's evaluation.\n4. Subjects without EGFR sensitive mutation, ALK fusion, ROS1 fusion or RET fusion. Subjects with squamous cell carcinoma are not required to undergo genetic testing. The Certificate of Analysis from the local laboratory is acceptable, but the test must be well validated and approved by the inter-laboratory quality assessment or NMPA (if the mutation is negative in blood test, it must be confirmed based on the results from tissue sample); if there is no previous Certificate of Analysis or the previous Certificate of Analysis does not meet the requirements, the sample should be provided for testing.\n5. At least 3 unstained tumor tissue sections were available for detection of PD-L1 and other biomarkers. If truly unable to provide tumor tissue samples as required, enrollment was also possible after communication with the sponsor.\n6. Function of vital organs meets the requirements.\n\nExclusion Criteria:\n\n1. In the company of the following study disease status:\n\n   1. Histopathologically or cytologically confirmed combined components of neuroendocrine tumours (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) and Pancoast tumor.\n   2. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.\n   3. Any clinically significant hemoptysis (≥2.5 ml) or Tumour haemorrhage of any cause within one month before the first use of the study drug.\n2. Received any of the following treatments:\n\n   1. Previous systemic antitumor therapy for NSCLC (including investigational drugs), such as chemotherapy or immunologically mediated therapy (including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4 therapy) and anti-angiogenic therapy (such as anti-VEGF pathway-targeted drugs);\n   2. Prior radiotherapy to chest;\n3. History of significant Haemorrhagic diathesis or severe Disorder coagulation, or Grade ≥3 bleeding event within 6 months prior to the first dose, or current ≥Grade 2 bleeding or factors that are judged by the investigator to be at high risk for bleeding (e.g., active peptic ulcer or Varices oesophageal).\n4. Gastrointestinal perforation, intra-abdominal fistula, or intra-abdominal abscess within 6 months prior to the first dose, or current risk factors for perforation\u002Ffistula formation of hollow organs as judged by the investigator, such as tumor invasion of the outer layer of hollow organ wall, or active inflammatory bowel disease (including Colitis ulcerative and Crohn's disease), Diverticulitis, Cholecystitis, symptomatic Cholangitis or Appendicitis.\n5. Existence of poorly controlled Hypertension, or history of Hypertensive crisis or Hypertensive encephalopathy.\n6. Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except Vitiligo or childhood asthma\u002Fallergy that has been cured, patients who do not require any intervention after adulthood, patients with autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormone, patients with hyperthyroidism adequately treated and well-controlled, and patients with type I Diabetes mellitus treated with a stable dose of Insulin, etc.\n7. Uncontrolled co-morbidities, including but not limited to: symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C50%, unstable angina, treated arrhythmia, aortic aneurysm requiring surgical repair, any arterial thrombotic\u002Fembolic events, Grade 3 or higher (CTCAE 5.0) venous thrombotic\u002Fembolic events, transient ischemic attack, cerebrovascular accident, tracheoesophageal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal obstruction.",true,{"count":342,"type":20},76,[51],"This is a phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1\u002FVEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. The study consists of 2 cohorts, including treatment-naïve and resectable subjects with stage II-III NSCLC (cohort 1), treatment-naïve and unresectalbe subjects with stage III NSCLC (cohort 2). Subjects in both cohorts will receive 3 cycles of JS207 + platinum-based doublet chemotherapy as neoadjuvant therapy, followed by surgery or definitive chemoradiotherapy, and then adjuvant therapy with JS207 (post-surgery) or consolidation therapy with JS207 (post-chemoradiotherapy).",[346],"NSCLC",{"date":348,"type":31},"2025-04-25",{"date":350,"type":20},"2025-04-20",{"date":271,"type":20},{"name":37,"class":38},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":63},"100465551","phase-3-toripalimab-plus-lenvatinib-and-gemcitabine-based-chemotherapy-in-1l-treatment-of-advanced-icc-a-phase-iii-study-100465551","NCT05342194","Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study","A Phase III, Randomized, Three-arm, Double-blind, Placebo-controlled, International Multi-center Study to Evaluate the Efficacy and Safety of Toripalimab in Combination With Lenvatinib and Gemcitabine-based Chemotherapy Compared With Gemcitabine-based Chemotherapy as First-line Treatment in Patients With Unresectable Advanced Intrahepatic Cholangiocarcinoma (ICC)","Inclusion Criteria:\n\n1. Age of 18-75 years (inclusive), male or female;\n2. Volunteer to participate in the study by signing the informed consent form and the ability to comply with the study protocol;\n3. Advanced ICC with diagnosis confirmed by histology or cytology;\n4. Stage II, III, or IV per TNM staging for ICC of the American Joint Committee on Cancer (AJCC) (8th edition, 2017). Those with Stage II or III should be determined to be unresectable by the investigator;\n5. Patients with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or transarterial radioembolization) for ICC. Patients with recurrent disease more than 6 months after completion of adjuvant chemotherapy following curative resection are eligible;\n6. Measurable lesion per RECIST v1.1;\n7. Child-Pugh class A with no history of hepatic encephalopathy;\n8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;\n9. Life expectancy ≥12 weeks;\n\nExclusion Criteria:\n\n1. Diagnosis of hepatocellular carcinoma (HCC), mixed cholangiocarcinoma and HCC, sarcomatoid hepatocellular carcinoma, or hepatic fibrolamellar carcinoma by histology or cytology;\n2. History of malignancy other than ICC within 5 years prior to screening, with the exception of localized malignancies that have been cured, including non-melanoma skin cancers, cervical carcinoma in situ, breast carcinoma in situ, and papillary thyroid carcinoma;\n3. Prior radiotherapy for ICC within 4 weeks prior to randomization;\n4. Major surgical procedures within 4 weeks prior to randomization;\n5. Side effects from prior therapy (except alopecia and pigmentation) that has not recovered to ≤ grade 1 (per NCI-CTCAE v5.0) or levels specified in the inclusion\u002Fexclusion criteria;\n6. Uncontrolled pericardial effusion, pleural effusion, or clinically significant moderate or severe ascites that is symptomatic or requires thoracentesis or paracentesis during the screening phase for control of symptoms;\n7. Gastrointestinal (GI) hemorrhage within 6 months prior to randomization and\u002For gastrointestinal varices that have not been assessed and treated, if appropriate, within 6 months prior to randomization.\n8. Gastrointestinal or non-gastrointestinal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization;\n9. Ongoing or a history of recurrent intestinal obstruction. Patients with a single episode of intestinal obstruction that has fully resolved following treatment are eligible allowed;\n10. History of serious cardiovascular and cerebrovascular diseases:\n11. Significant bleeding and coagulopathy or other evidence of bleeding diathesis, to include:\n12. Pre-existing CNS metastases and\u002For meningeal metastases (including dural metastases and leptomeningeal metastases);\n13. Serious non-healing wound, active ulcer, or untreated bone fracture;\n14. Vaccination with live virus or bacteria within 30 days prior to randomization;\n15. Active autoimmune disease or history of autoimmune disease",{"count":361,"type":20},480,[218],"This is a Phase III, prospective, randomized, three-arm, double-blind, placebo-controlled, international multicenter study to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and gemcitabine-based chemotherapy compared with gemcitabine-based chemotherapy as first-line treatment for unresectable advanced ICC.\n\nThis study will enroll approximately 480 patients with unresectable advanced ICC who have received no prior systemic therapy. Patients who meet the requirements will be randomly assigned to Treatment Arm A: Toripalimab, lenvatinib, and gemcitabine-based chemotherapy or Treatment Arm B: Toripalimab, oral placebo, and gemcitabine-based chemotherapy or Treatment Arm C: Intravenous placebo, oral placebo, and gemcitabine-based chemotherapy.\n\nAll patients will receive standard chemotherapy (GEMOX or GC per Investigator decision) for a maximum of 8 cycles. After the completion of standard chemotherapy, all patients continue to receive maintenance therapy with toripalimab injection or its placebo in combination with lenvatinib mesylate capsule or its placebo until unacceptable toxicity, confirmed disease progression and loss of clinical benefit as determined by the investigators, start of new anti-cancer therapy, death, other conditions requiring termination of study treatment, or the patient meets the criteria for study withdrawal, whichever occurs first.\n\nIn the absence of unacceptable toxicity, patients who meet criteria for unconfirmed disease progression per RECIST v1.1 while receiving toripalimab, lenvatinib, or their placebos will be permitted to continue treatment if their clinical status or symptoms are stable or improved (as determined by the investigators) or until loss of clinical benefit. Patients with confirmed disease progression should discontinue toripalimab, lenvatinib, or their placebos.\n\nTumor assessments will be performed at screening and during the study treatment per protocol. In the absence of progression, tumor assessments will continue as scheduled, regardless of whether study treatment ends, until confirmed disease progression or other criteria for study withdrawal are met, whichever occurs first. Patients who meet RECIST v1.1 criteria for progression should undergo tumor assessments as scheduled if clinical benefits of continuing study treatment are determined by investigators until progression is confirmed per iRECIST (iCPD), or the criteria for study withdrawal are met, whichever occurs first.\n\nComputerized tomography (CT)\u002Fmagnetic resonance imaging (MRI) scans for efficacy evaluation will be performed at baseline, every 6 weeks (Q6W) in the first year (52 weeks), and every 9 weeks (Q9W) in the second year (after week 52).\n\nAll AEs and concomitant medications during the study will be recorded. An end-of-treatment (EOT) visit will be performed within 30 days after the last dose of study treatment or termination of study treatment is confirmed by the investigator. After the EOT visit, follow-up for survival (telephone visit is allowed) will be conducted and AEs and subsequent anti-cancer therapy will be collected.",[365],"Intrahepatic Cholangiocarcinoma",[367,368,369,370],"Intrahepatic cholangiocarcinoma","Toripalimab","lenvatinib","Chemotherapy","2025-04-17",{"date":311,"type":31},{"date":374,"type":31},"2023-06-19",{"date":376,"type":20},"2027-05-31",{"name":37,"class":38},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":21,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":63},"100529185","phase-3-a-phase-iii-clinical-study-comparing-js004-plus-toripalimab-with-investigator-selected-chemotherapy-in-patients-with-pd-l1monoclonal-antibody-refractory-classic-hodgkin-lymphoma-chl-100529185","NCT06170489","A Phase III Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)","A Phase III, Randomised, Open-label,, Multi-Center Clinical Study Comparing JS004 Plus Toripalimab With Investigator-Selected Chemotherapy in Patients With PD-(L)1 Monoclonal Antibody Refractory Classic Hodgkin Lymphoma (cHL)","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be enrolled:\n\n* Age at least 18 years old, both males and females are eligible\n* Pathologically confirmed classical Hodgkin Lymphoma (cHL) with either relapsed (disease progression after achieving CR\u002FPR in recent treatment) or refractory (failure to achieve CR\u002FPR in recent treatment) status.\n* Has exhausted all standard treatment and refractory to PD-(L)1 monoclonal antibody (mAb)\n* ECOG: 0-2\n* At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to the investigational drug or its components\n* Permanent discontinuation of anti-PD-(L)1 antibody due to immune-related adverse reactions.\n* Presence of central nervous system (CNS) metastasis.\n* Presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage)\n* Active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years",{"count":386,"type":20},185,[218],"The study is being conducted to compare JS004 plus Toripalimab with Investigator-Selected Chemotherapy in Patients with PD-(L)1 monoclonal antibody refractory Classic Hodgkin Lymphoma (cHL)",[390],"Hodgkin Lymphoma","2025-02-26",{"date":393,"type":31},"2025-02-28",{"date":395,"type":31},"2023-12-28",{"date":397,"type":20},"2027-09-30",{"name":37,"class":38},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":406,"targetDuration":4,"studyType":21,"phases":408,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":63},"100559998","phase-1-phase-i-study-of-wj47156-monotherarpy-and-in-combination-with-other-therapy-in-advanced-solid-tumors-100559998","NCT06571422","Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WJ47156 Monotherapy and in Combination With Other Anti-Tumor Therapies in Patients With Advanced Malignant Solid Tumors","Inclusion criteria:\n\n1. Male or female, 18 to 75 years old (inclusive) at the time of signing the ICF;\n2. Patients with histologically or cytologically confirmed advanced malignant solid tumors；\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n4. Life expectancy ≥ 12 weeks;\n5. At least one measurable lesion according to RECIST 1.1;\n6. Adequate organ function ；\n7. Female or male patients of childbearing potential must agree that they have no intention to become pregnant during the study and for 6 months after the last dose, and to use highly effective contraceptive methods with their partners; );\n8. Voluntary participation with full informed consent by signing an written informed consent, and with good compliance.\n\nExclusion Criteria\n\n1. CNS metastasis；\n2. Pleural effusion, peritoneal effusion or pericardial effusion with clinical symptoms or requiring repeated treatment (e.g., puncture or drainage);\n3. Unable to swallow tablets, intestinal obstruction, or other factors affecting the administration and gastrointestinal absorption of tablets\n4. For the combination therapy, patients will not be enrolled in this study if they meet any of the following criteria:\n\n（1）Imaging findings at screening showing tumor encasement of a major vessel or significant necrosis and cavity, which may lead to a hemorrhagic risk as judged by the investigator; （2）Patients with active autoimmune diseases requiring systemic treatment (e.g., corticosteroids or immunosuppressive drugs) within 2 years prior to the first dose, including but not limited to systemic systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, vasculitis, etc. However, hypothyroidism, hypoadrenalism or hypopituitarism controlled only by hormone replacement therapy, Type I diabetes mellitus not requiring systemic treatment, psoriasis or vitiligo are allowed; （3）Previously treated with anti-PD-1\u002FL1 therapy; （4）History of interstitial lung disease or previous history of non-infectious pneumonia treated with corticosteroids, or evidence of active pneumonia on imaging at screening; （5）Gastrointestinal perforation, fistula, abdominal abscess and ulcerative disease or history of digestive system ulcerative disease within 6 months prior to the first dose (patients with stable ulcer as assessed by the investigator may be considered for enrollment); （6）Presence of serious, unhealed, or open wounds, active ulcers, or untreated fractures; （7）History of gastrointestinal bleeding within 6 months prior to enrollment, or clear tendency of gastrointestinal bleeding (including hemorrhagic risk of severe esophageal-gastric varices, locally active digestive tract ulcerative lesion, and persistent positive fecal occult blood); （8）Clinically significant hemoptysis or tumor bleeding for any reason within one month prior to the first dose; （9）History of obvious bleeding tendency or severe coagulation dysfunction; （10）Severe drug-related adverse events leading to permanent discontinuation of the drug product or bevacizumab or its analogues; （11）Use of antiplatelet therapy or anticoagulant therapy for treatment within 14 days prior to the first dose; （12）Long-term treatment with nonsteroidal anti-inflammatory drugs is permitted for brief periods of time to relieve symptoms such as fever or pain.\n\n5\\. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg) or history of hypertensive crisis or hypertensive encephalopathy; 6. Severe cardiovascular disease, including but not limited to, myocardial infarction, severe\u002Funstable angina, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ 2), clinically significant supraventricular or ventricular arrhythmia requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis\u002Fembolism event, Grade 3 or higher (Common Terminology Criteria for Adverse Events \\[CTCAE\\] v5.0) venous thrombosis\u002Fembolism event, transient ischemic attack, cerebral vascular accident; Left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiography. Corrected QT interval (QTc) \\> 480 ms (calculated using the Fridericia method; if QTc is abnormal, measure 3 times at an interval of 2 minutes and use the average).\n\n7\\. Serious infection (CTCAE Grade \\> 2) within 28 days prior to the first dose, such as serious pneumonia, bacteremia, infection and complications requiring hospitalization; or active infection or unknown cause of fever (\\>38.5℃) requiring systemic anti-infection treatment within 2 weeks prior to the first dose (as judged by the investigator, patients with tumor-induced fever can be enrolled);\n\n8\\. Presence of active tuberculosis, hepatitis B (positive for hepatitis B surface antigen \\[HBsAg\\] and HBV DNA higher than the lower limit of detection in the study site), hepatitis C (positive for HCV antibody \\[HCVAb\\] and HCV RNA higher than the lower limit of detection in the study site);\n\n9\\. History of immunodeficiency, including human immunodeficiency virus (HIV) positive test, or history of known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n\n10\\. History of another primary malignant tumor, with the exception of malignant tumors (e.g., basal cell carcinoma of skin and squamous cell carcinoma of skin) who have received potentially curative therapy (more than 5 years) without known active disease prior to the first dose, without potential risk for recurrence ;\n\n11\\. Toxicity of previous antitumor therapy has not been recovered to CTCTAE Grade ≤ 1 or to the level specified in the inclusion\u002Fexclusion criteria, with the exception of the following: related toxicities that are well controlled as judged by the investigator and do not affect the safety and compliance of the study treatment, and can be screened after confirmation by the Sponsor;\n\n12\\. Prior use of the following drugs or therapies before the first dose:\n\n1. Having received chemotherapy, immunotherapy or other anti-tumor therapy or other investigational drug within 21 days prior to the first dose, or having received oral fluorouracil, small-molecule targeted drugs or Chinese herbal products for antitumor indications within 14 days prior to the first dose;\n2. Major surgery, radiation therapy (with the exception of palliative radiation to a localized bone or brain lesion, which may be completed up to 14 days prior), or any other minor surgical procedure, excluding placement of vascular access devices, within 28 days prior to the first dose; and any biopsy or other minor procedure within 7 days prior to the first dose.\n3. In the combination therapy phase, patients who have received systemic treatment with corticosteroids (more than 10 mg\u002Fday prednisone or equivalent) or other immunosuppressants within 2 weeks prior to the first dose are allowed to use inhaled or topical steroids or systemic prednisone ≤10 mg\u002Fday and equivalent drug product;\n4. Having received any live vaccine or attenuated live vaccine within 28 days prior to the first dose or requiring to be vaccinated with live vaccine or attenuated live vaccine during the study (only for patients in combination therapy phase);\n\n   13\\. Patients who, in the opinion of the investigator, may be at increased risk of participation in the study due to other serious physical or mental diseases or abnormal laboratory examination, or may affect the compliance with treatment or interfere with the study results, and are not suitable for participation in this study.",{"count":407,"type":20},93,[23],"This study is an open-label, dose-escalation and expansion, Phase I clinical study to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of WJ47156 monotherapy and in combination with toripalimab in patients with advanced malignant solid tumors. The study consists of two parts, including monotherapy (Part 1) and combination therapy (Part 2).",[54],[412],"Solid Tumors","2025-02-19",{"date":33,"type":31},{"date":416,"type":31},"2024-10-23",{"date":418,"type":20},"2027-04-30",{"name":37,"class":38},{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":427,"targetDuration":4,"studyType":21,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":63},"100526781","phase-1-a-phase-ibii-study-of-js015-combination-therapy-in-advanced-solid-tumors-100526781","NCT06139211","A Phase Ib\u002FII Study Of JS015 Combination Therapy in Advanced Solid Tumors","A Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1\\. Patients who meet the following criteria for each indication cohort:\n\n1. Esophageal cancer cohort, patients with histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable or with distant metastasis, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;\n2. Gastric cancer cohort, patients with histologically or cytologically confirmed gastric\u002Fgastroesophageal junction adenocarcinoma with locally advanced unresectable or distant metastases, HER2-negative, who progressed during or after prior first-line PD-(L)1 antibody and platinum-based chemotherapy;\n3. 1L gastric cancer cohort, patients with histologically or cytologically confirmed gastric\u002Fgastroesophageal junction adenocarcinoma with HER2-negative results and no prior systemic antitumor therapy;\n4. Colorectal cancer cohort, patients with histologically confirmed adenocarcinoma of the colon or rectum, who progressed during or after first-line 5-FU-based combination therapy;\n5. Pancreatic cancer cohort, patients with histologically or cytologically confirmed locally advanced unresectable or distant metastatic pancreatic ductal adenocarcinoma, who have not received any previous systemic antitumor therapy 2 . Eastern Cooperative Oncology Group (ECOG) 0 or 1; 3. Life expectancy \\>=12 weeks; 4. At least one measurable lesion according to RECIST 1.1; 5. Adequate organ function;\n\nExclusion Criteria:\n\n1. Leptomeningeal metastases and \u002For active brain metastases;\n2. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.);\n3. History of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging;\n4. History of immunodeficiency;\n5. History of serious cardiovascular and\u002For cerebrovascular diseases;\n6. History of abdominal or tracheo-esophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months before the first dose of administration",{"count":428,"type":20},186,[23,51],"This is a phase Ib\u002FII, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics and efficacy.",[432],"Advanced Solid Tumor","2024-12-17",{"date":435,"type":31},"2024-12-20",{"date":437,"type":31},"2024-01-03",{"date":439,"type":20},"2026-01-28",{"name":37,"class":38},{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":237,"enrollmentInfo":448,"targetDuration":4,"studyType":21,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":63},"100486976","phase-3-efficacy-and-safety-of-js002-as-monotherapy-in-patients-with-primary-hypercholesterolaemia-and-mixed-dyslipidemia-100486976","NCT05621070","Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia","A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia","Inclusion Criteria:\n\n1. Signed informed consent\n2. Age 18\\~80 years old\n3. Subject who has not achieve LDL-C goal as categorized by their CV risk at screening\n4. Fasting TG≤4.5mmol\u002FL by central laboratory at screening\n5. Statin intolerance subject must have a history of statin intolerance as evidenced\n\nExclusion Criteria:\n\n1. History of hemorrhagic stroke\n2. NYHA III or IV heart failure, or known LVEF\\\u003C 30% within 1 year before randomization\n3. Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization\n4. Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization\n5. Planned cardiac surgery or revascularization\n6. Uncontrolled hypertension defined as sitting systolic blood pressure(SBP) \\> 160 mmHg or diastolic BP (DBP) \\> 100 mmHg\n7. Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c \\> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization)\n8. Others factors not suitable for participation judged by PI",{"count":449,"type":20},582,[218],"JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK\u002FPD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia.\n\nIn this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150\u002F450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.",[453],"Primary Hypercholesterolaemia and Mixed Dyslipidemia","2024-09-09",{"date":456,"type":31},"2024-09-19",{"date":458,"type":31},"2023-02-03",{"date":460,"type":20},"2024-09-30",{"name":37,"class":38},{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":21,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},"100523430","phase-3-phase-3-study-of-toripalimab-alone-or-in-combination-with-tifcemalimab-as-consolidation-therapy-in-patients-with-limited-stage-small-cell-lung-cancer-ls-sclc-100523430","NCT06095583","Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)","A Randomized, Double-Blind, Placebo-Controlled, Multi-Regional Phase III Clinical Study of Toripalimab Alone or in Combination With Tifcemalimab (JS004\u002FTAB004) as Consolidation Therapy in Patients With Limited-Stage Small Cell Lung Cancer Without Disease Progression Following Chemoradiotherapy","Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be enrolled:\n\n1. Male or female with age ≥ 18 years old at the time of informed consent.\n2. Histologically or cytologically confirmed LS-SCLC using the Veteran's Administration Lung Study Arm (VALSG) staging criteria (Appendix 3). Patients with TNM Stage I or II disease per AJCC 8th edition must be medically inoperable (as determined by the Investigator) or the patient must refuse surgery.\n3. Received CRT defined as: (1) 4 cycles of chemotherapy consisting of carboplatin or cisplatin and intravenously administered etoposide; (2) a total radiation dose of 60-66 Gy for the standard once daily (QD) radiotherapy regimen or 45 Gy for the hyperfractionated twice daily (BID) radiotherapy regimen; (3) Patients must begin investigational interventions within 42 days of the last dose of chemotherapy.\n4. Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 .\n6. Adequate organ function\n7. Female patients of childbearing potential and male patients whose partners are women of childbearing age.\n8. Voluntarily agree to participate in the study, sign the informed consent form, and agree to comply with all study and follow-up procedures.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria.\n\n1. Mixed SCLC and non-small cell lung cancer (NSCLC).\n2. Received sequential chemoradiotherapy for LS-SCLC.\n3. Failure to recover from toxicity of prior anticancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 (except alopecia) or levels specified in the inclusion\u002Fexclusion criteria, whichever is more severe.\n4. Patients with active autoimmune disease, history of autoimmune disease.\n5. History of immunodeficiency, including HIV seropositivity, other acquired congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.\n6. History of confirmed or suspected interstitial lung disease or pneumonitis (except for Grade 1 radiation pneumonitis not treated with corticosteroids).\n7. The presence of active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (hepatitis C antibodies positive and HCV-RNA higher than the lower limit of detection of the analytical method).\n8. Any other malignancy diagnosed prior to the first dose of investigational intervention, except those with a low risk for the development of metastases (5-year survival rate \\> 90%), such as adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or adequately treated localized prostate cancer.\n9. Women who are pregnant or breastfeeding.",{"count":470,"type":20},756,[218],"The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy.\n\nTifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.",[474],"Limited-stage Small Cell Lung Cancer (LS-SCLC)","2024-06-19",{"date":477,"type":31},"2024-06-21",{"date":479,"type":31},"2023-11-15",{"date":481,"type":20},"2029-07-31",{"name":37,"class":38},156,""]