[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Sanhome Pharmaceutical, Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100623148","phase-2-a-clinical-study-of-sh006-injection-in-combination-therapy-versus-regorafenib-in-the-treatment-of-advanced-hepatocellular-carcinoma-100623148",false,"NCT07392866","A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma","A Prospective, Randomized, Active-Controlled, Open-Label, National Multicenter Phase II\u002FIII Registration Study of SH006 Injection Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Subjects participate voluntarily and sign informed consent.\n* Age ≥ 18 and ≤ 75 years old, male or female.\n* Histological or clinical diagnosis of HCC.\n* Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and\u002For local treatment\n* Previous treatment with a drug containing an immune checkpoint inhibitor failed.\n* Child-Pugh ≤7 , no history of hepatic encephalopathy.\n\nExclusion Criteria:\n\n* Histologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, etc.\n* History of malignancy other than HCC within 5 years prior to the start of study treatment.\n* History of liver transplantation, or planned to receive liver transplantation.\n* Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.","ALL","18 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma",[28],"Hepatocellular Carcinoma (HCC)",[30,31],"hepatocellular carcinoma","immune checkpoint inhibitors","NOT_YET_RECRUITING","2026-02-05",{"date":35,"type":36},"2026-02-09","ACTUAL",{"date":38,"type":21},"2026-03-01",{"date":40,"type":21},"2030-03-01",{"name":42,"class":43},"Nanjing Sanhome Pharmaceutical, Co., Ltd.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100622993","phase-1-a-study-of-sh009-injection-in-patients-with-advanced-solid-tumors-100622993","NCT07390838","A Study of SH009 Injection in Patients With Advanced Solid Tumors.","An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n* (1) Age≥18 years old at the time of informed consent, male or female;\n* (2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy;\n* (3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy;\n* (4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analyses;\n* (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;\n* (6) Life expectancy ≥12 weeks;\n* (7) Bone marrow function meets the following criteria: neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 90 × 10\\^9\u002FL (platelet count ≥ 75 × 10\\^9\u002FL in patients with liver cancer); hemoglobin (Hb) ≥ 90 g\u002FL;\n* (8) Liver function meets the following criteria: total bilirubin(TBIL) ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome); aspartate aminotransferase (AST) and alanine and aminotransferase (ALT) ≤ 3 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver cancer or liver metastases);\n* (9) Renal function meets the following criteria: serum creatinine clearance(CLcr) ≥ 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula); urine dipstick test results show that urine protein \\\u003C 2 +, urine protein ≥ 2 + subjects should undergo 24-hour urine collection and urine protein content \\\u003C 1g within 24 hours;\n* (10) Coagulation function meets the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5× ULN;\n* (11) Female subjects of childbearing potential must use effective contraception during the trial and for 6 months after the last dose, and have a negative pregnancy test within 7 days before treatment initiation (except those who are surgically sterilized or postmenopausal). Male subjects must agree to use effective contraception during the trial and for 6 months after the last dose;\n* (12) The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form.\n\nExclusion Criteria:\n\n* (1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47\u002FSIRPα recombinant protein;\n* (2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose;\n* (3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks. Mitomycin or nitrosoureas within 6 weeks. Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer).Chinese\u002Fherbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area;\n* (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period;\n* (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo elective surgery during the trial period;\n* (6) Patients who received systemic glucocorticoids (dexamethasone \\> 10 mg\u002F day or equivalent dose of the same drug) or other immunosuppressive therapy within 14 days before the first administration; except for topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast allergy);\n* (7) Symptomatic brain parenchymal or leptomeningeal metastases, deemed by the investigator as unsuitable for enrollment;\n* (8) Prior immunotherapy with ≥Grade 3 irAE or ≥Grade 2 immune-related myocarditis;\n* (9) Severe or uncontrolled systemic disease, including but not limited to: uncontrolled pleural or peritoneal effusion; uncontrolled diabetes; ventricular arrhythmia requiring intervention; acute coronary syndrome, congestive heart failure, stroke, or other ≥Grade 3 cardiovascular event within 6 months; NYHA Class ≥II or LVEF \\\u003C50%; clinically significant QTcF prolongation or arrhythmia risk (baseline QTcF \\>450 msec for males or \\>470 msec for females); clinically uncontrolled hypertension (SBP \\>160 mmHg and\u002For DBP \\>90 mmHg after treatment) as judged by the investigator. Subjects judged by the investigator as unsuitable due to any such condition;\n* (10) History of pneumonia requiring hormone therapy or interstitial lung disease (including past and current history); active pulmonary infection;\n* (11) Active infection requiring intravenous anti-infective therapy within 1 week prior to study drug administration (fever attributed to the tumor per investigator's judgment is acceptable). History of self-limited infections that have resolved is acceptable;\n* (12) Active Hepatitis B, Hepatitis C, or syphilis infection. Subjects positive for HBeAb or HBsAg are eligible if HBV-DNA ≤200 IU\u002FmL. Subjects positive for HCV-Ab are eligible if HCV-RNA ≤ the upper limit of normal at the research center. Subjects with hepatocellular carcinoma and HBV-DNA ≥2000 IU\u002FmL must receive antiviral\u002Fhepatoprotective therapy first and can only enroll after HBV-DNA decreases to \\\u003C2000 IU\u002FmL;\n* (13) History of primary immunodeficiency, including positive human immunodeficiency virus (HIV) test, or suffering from other acquired, congenital immunodeficiency diseases;\n* (14) History of other malignancies within 5 years prior to the first dose, except for:\n\n  a) Any other invasive malignancy, treated with curative intent, with a disease-free interval \\>3 years and deemed by the investigator not to affect efficacy evaluation for the current tumor. b) Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or other locally cured cancers;\n* (15) History or presence of autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis or high risk (e.g., post-transplant immunosuppression). Exceptions: stable type 1 diabetes on fixed-dose insulin; autoimmune hypothyroidism on hormone replacement only; skin conditions not requiring systemic treatment (e.g., eczema, rash covering\\\u003C10% BSA, psoriasis without ocular symptoms);\n* (16) Arterial thromboembolic events within 6 months prior to the first dose, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose (catheter-related or superficial venous thrombosis is not considered \"serious\"). Receiving thrombolytic or anticoagulant therapy for high thrombotic risk;\n* (17) Subjects who had receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplant);\n* (18) According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss, pigmentation, hypothyroidism stabilized by hormone replacement therapy and peripheral neuropathy (need to recover to ≤ grade 2)). Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the study drug may be allowed after consultation with the medical monitor;\n* (19) Known history of severe hypersensitivity to macromolecular protein preparations\u002Fmonoclonal antibodies(CTCAE v5.0 Grade ≥3), or any component of the study drug;\n* (20) Known alcohol and\u002For drug dependence, or any other condition deemed by the investigator to affect the safety or compliance of the study treatment, including but not limited to psychiatric disorders;\n* (21) Pregnant or lactating women.",{"count":53,"type":21},150,[55],"PHASE1","Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors",[58,59,60,61,62,63,64],"Liver Cancer (Locally Advanced or Metastatic)","Lung Cancer (NSCLC)","Head and Neck Cancer Squamous Cell Carcinoma","Breast Cancer (Locally Advanced or Metastatic)","Esophageal Cancer","Gastric Cancer (GC)","Solid Tumor Malignancies","RECRUITING","2026-01-28",{"date":33,"type":36},{"date":69,"type":36},"2025-05-16",{"date":71,"type":21},"2028-12-30",{"name":42,"class":43},1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":73},"100522296","phase-3-sh-1028-tablets-versus-placebo-as-adjuvant-therapy-in-resected-stage-ii-iiib-nsclc-with-sensitizing-egfr-mutations-100522296","NCT06080776","SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations","A Phase III, Double-blind, Randomised Study of SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations","Inclusion Criteria:\n\n* Male or female, aged at least 18 years, younger than 75 years.\n* Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.\n* Before surgery or randomization, MRI or CT scan of the brain and bone scan must be done to exclude metastases.\n* Complete resection (R0) and systematic lymphadenectomy are mandatory: all surgical margins must be negative for tumor, and there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes.\n* Patients with postoperative pathological confirmation of stage II, IIIA and IIIB (only T3N2M0) are eligible.\n* Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M, the mutations should be confirmed by the central laboratory.\n* Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.\n* A ECOG performance status equal to 0-1 with a minimum life expectancy of 12 weeks and no deterioration over the past 2 weeks.\n* Adequate bone marrow reserve or organ function, as demonstrated by the following laboratory values (no corrective treatment allowed within one week before blood sampling):\n\n  1. Absolute neutrophil count (ANC）≥1.5×10\\^9 \u002FL\n  2. Platelet count ≥100×10\\^9 \u002FL\n  3. Hemoglobin ≥90 g\u002FL\n  4. Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases\n  5. Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases\n  6. Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n  7. Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL\u002Fmin (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is ≤ 1.5×ULN\n  8. Serum albumin (ALB) ≥28 g\u002FL\n  9. Coagulation function: International standardized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN\n* Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding during the study and until 6 months after treatment, and must have a negative pregnancy test prior to start of dosing.\n* Male patients should be willing to use barrier contraception during the study and until 6 months after treatment.\n* Patients must sign and date written informed consent prior to admission to the study.\n\nExclusion Criteria:\n\n* Patients with unresectable or metastatic lesions, residual lesions after surgery, or those who have had only segmentectomies or wedge resection.\n* Giant mediastinal lymph node metastasis at a single station or mediastinal lymph node fusion into a cluster at multiple stations; lesions invade the heart, aorta, esophagus, or pulmonary veins; Carcinoma of superior lung sulci.\n* Treatment with any of the following (except for standard platinum -based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy，immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.\n* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.\n* The patient is currently using (or cannot discontinue at least 1 week before the first dose of study drug) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.\n* Severe infections occurred within 4 weeks or active infections that received therapeutic intravenous or oral antibiotics within 2 weeks before the first dose.\n* Any evidence of active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus).\n* Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose; require long-term (≥30 days) steroid therapy; with acquired or congenital immunodeficiency diseases or have a history of organ transplantation.\n* Severe or uncontrolled systemic diseases, including hypertension or diabetes.\n* Any of the following cardiac criteria:\n\n  1. Mean resting corrected QT interval (QTcF) \\> 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic's ECG machine and Fridericia's formula for QT interval correction.\n  2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \\>250 msec).\n  3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.\n  4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n* Receiving or requiring drugs known to prolong the QT interval or possibly cause tip torsion ventricular tachycardia during the study.\n* History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n* History of any other malignant tumor within five years (except clinically cured cervical carcinoma in situ, basal cells or squamous epithelial skin cancer).\n* Any seriously abnormal gastrointestinal function would affect uptake, transport and absorption of the drug, such as inability to swallow the study medication, refractory nausea and vomiting, previous significant bowel resection, Recurrent diarrhea, atrophic gastritis (age \\\u003C 60 years), unhealed serious gastric diseases, Crohn's disease or ulcerative colitis.\n* History of hypersensitivity to any active or inactive ingredient of SH-1028 or drug with a similar chemical structure or class to SH-1028.\n* Any severe and uncontrolled ocular disease that may, in the Investigator's opinion, present a specific risk to the patient's safety.\n* Participating in another clinical trial within 4 weeks before the first dose (excluding retrospective observational studies without intervention); within 5 half-lives of other study drugs.\n* Hepatic encephalopathy, hepatorenal syndrome, or ≥Child-Pugh grade B cirrhosis.\n* Lactating Women.\n* Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.",{"count":82,"type":21},242,[25],"To assess the efficacy and safety of SH-1028 tablets versus placebo in stage II-IIIB non-small cell lung cancer (NSCLC) patients with sensitizing epidermal growth factor receptor (EGFR) mutations, following complete tumor resection, with or without adjuvant chemotherapy.",[86],"Non-small Cell Lung Cancer","2023-10-06",{"date":89,"type":36},"2023-10-12",{"date":91,"type":36},"2023-05-11",{"date":93,"type":21},"2031-02-01",{"name":42,"class":43},""]