[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiyan Liu\",\"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,[8,45,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100632845","phase-2-egfr-adc-becotatug-vedotin-combined-with-pd-1-inhibitor-pucotenlimab-in-neoadjuvant-treatment-of-advanced-penile-cancer-100632845",false,"NCT07518979","EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) in Neoadjuvant Treatment of Advanced Penile Cancer","Neoadjuvant Therapy With EGFR-ADC (Becotatug Vedotin) Combined With PD-1 Inhibitor (Pucotenlimab) for Penile Squamous Cell Carcinoma With Penile Preservation Difficulty or Regional Lymph Node Metastasis: A Single-Arm, Phase II Clinical Trial","MH-Penile-002","1. Inclusion Criteria （1）Histologically\u002Fcytologically confirmed penile squamous cell carcinoma (PSCC); （2）EGFR expression (IHC 1+, 2+, or 3+) confirmed by local pathology department; （3）No prior systemic therapy, or recurrence ≥6 months after adjuvant therapy for radical resection; （4）Male, aged ≥18 years; （5）Cytologically positive or clinically palpable inguinal lymphadenopathy, fixed mass, radiologically diagnosed pelvic lymph node metastasis, or penile preservation difficulty (unable to perform surgery with negative margin and functional penile stump preservation); （6）At least one measurable lesion per RECIST 1.1; （7）Adequate organ function:\n\n   * Left ventricular ejection fraction (LVEF) ≥50%;\n   * Hemoglobin (HGB) ≥90 g\u002FL, white blood cell (WBC) ≥3.0×10⁹\u002FL, absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet (PLT) ≥80×10⁹\u002FL;\n   * Total bilirubin (TBIL) ≤1.5×ULN, AST\u002FALT ≤2.5×ULN (≤5×ULN for liver metastasis), serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin; （8）Voluntarily participate, understand the study, and sign informed consent form.\n2. Exclusion Criteria （1）Prior systemic therapy (except recurrence ≥6 months after adjuvant chemotherapy for radical resection); （2）Severe concurrent diseases or poor physical condition unsuitable for treatment\u002Fsurgery (e.g., severely ulcerated\u002Finfected inguinal lymph nodes with high risk of poor wound healing); （3）Uncontrolled comorbidities: uncontrolled infection, active tuberculosis, uncontrolled diabetes, cardiovascular diseases (NYHA class III\u002FIV heart failure, ≥grade 2 heart block, myocardial infarction within 12 months, unstable arrhythmia\u002Fangina, cerebral infarction within 6 months), interstitial lung disease, deep vein thrombosis\u002Fpulmonary embolism within 12 months, decompensated cirrhosis; （4）Active autoimmune diseases requiring systemic treatment within 2 years (except physiological replacement therapy); （5）Positive serological tests: HIV positive; HBsAg positive with HBV DNA ≥2000 copies\u002FmL; HCV antibody positive with positive HCV RNA; （6）Major surgery within 4 weeks prior to enrollment, prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation; （7）Vaccination with anti-tumor vaccine within 4 weeks prior to enrollment or planned during the study; （8）Other conditions deemed unsuitable by the investigator.","MALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This clinical study is a Phase II research trial focused on a new preoperative treatment for men with advanced penile squamous cell carcinoma (a type of penile cancer). The cancer may be hard to treat with penile-sparing surgery, or it may have spread to nearby lymph nodes (like groin lymph nodes).\n\nWe are testing a combination of two medicines: Becotatug vedotin (a targeted therapy that finds and kills cancer cells with high levels of a protein called EGFR) and Pucotenlimab (an immunotherapy that helps your body's immune system fight cancer). The goal is to see if this combination can shrink the tumor, make surgery more likely to remove all cancer cells, and improve treatment outcomes-while keeping side effects manageable.\n\nWho can join?\n\nTo be eligible, you must:\n\nBe a man 18 years or older with confirmed penile squamous cell carcinoma; Have cancer that is hard to treat with penile-sparing surgery or has spread to regional lymph nodes; Have cancer cells that test positive for EGFR (a protein most penile cancers make); Have not received prior systemic cancer treatment (or had recurrence more than 6 months after adjuvant therapy for radical resection); Have adequate organ function (e.g., healthy heart, liver, and kidney function) to tolerate treatment; Understand the study and voluntarily agree to participate by signing an informed consent form.\n\nWhat will happen during the study? Screening (up to 28 days): You will have tests to confirm eligibility, including imaging scans, blood work, and EGFR testing on your tumor sample.\n\nPreoperative treatment (4-6 cycles): You will receive intravenous infusions of Becotatug vedotin (2.0 mg\u002Fkg) and Pucotenlimab (200 mg) every 3 weeks. Every 6 weeks, you will have imaging scans to check if the tumor is shrinking.\n\nSurgery: If the tumor responds to treatment (assessed by a team of doctors), you will undergo radical surgery to remove the cancer. If surgery is successful, you may continue Pucotenlimab as adjuvant therapy for 1 year.\n\nFollow-up: After treatment, you will be checked every 3 months for 2 years to monitor for cancer recurrence and long-term side effects.\n\nWhat are the study goals? Primary goal: To find out how many patients can have successful surgery to remove all visible cancer (R0 resection) after the combination treatment.\n\nSecondary goals: To measure how much the tumor shrinks (objective response rate), if the cancer stage improves (downstaging rate), if surgery removes all cancer cells (pathological complete response rate), how long patients stay cancer-free (disease-free survival), and how safe the treatment is.\n\nWhat are the potential risks? As with any cancer treatment, this combination may cause side effects. Common expected side effects include skin reactions (e.g., rash), digestive issues, changes in blood cell counts, liver function changes, and immune-related reactions (e.g., thyroid problems, lung inflammation). These side effects will be closely monitored by the study team, and treatments to manage them will be provided.\n\nThis study is being conducted at West China Hospital, Sichuan University. It is a single-arm trial (all participants receive the same combination treatment) and will enroll about 60 patients. The study is expected to run from April 2026 to April 2028.",[27],"Penile Cancer",[29,30,31],"penile cancer","ADC","PD-1","NOT_YET_RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":21},"2026-07-30",{"date":40,"type":21},"2031-05-01",{"name":42,"class":43},"Jiyan Liu","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100596877","phase-1-a-trial-to-evaluate-the-efficacy-and-safety-of-wgc0201-in-patients-with-chronic-hepatitis-b-virus-infection-100596877","NCT07051187","A Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection","An Open-Label, Single-Arm, Dose-Escalation Phase I Clinical Trial to Evaluate the Efficacy and Safety of WGc0201 in Patients With Chronic Hepatitis B Virus Infection","WGc0201-HBV","Inclusion Criteria:\n\n1. Adult males or females aged ≥18 to ≤65 years;\n2. 18≤ BMI ≤32 kg\u002Fm2;\n3. Diagnosis of chronic hepatitis B infection (HBsAg positive for more than 6 months and detectable at screening);\n4. Received only nucleoside (acid) analog therapy in the 12 months prior to screening and are still taking it regularly;\n5. HBV-DNA viral load below 100 IU\u002Fml;\n6. HBsAg \\\u003C1500 IU\u002Fml.\n\nExclusion Criteria:\n\n1. Includes HIV, co-infection with HDV, and liver biopsy suggestive of cirrhosis or advanced fibrosis within 6 months prior to screening (Metavir activity level A3 and stages F3 and F4; Ishak stages 4-6);\n2. If no liver biopsy was documented, a Fibroscan screen result \\>9 kPa (or equivalent) or a FibroTest screen result \\>0.48 and an APRI (Aspartate Aminotransferase to Platelet Ratio Index) \\>1 within ≤6 months of screening.\n3. Alanine aminotransferase \\>3x ULN;\n4. Internationally standardized ratio \\> 1.5;\n5. Albumin \\\u003C3.5 g\u002Fdl;\n6. Direct bilirubin \\> 1.5x ULN;\n7. Platelet count \\\u003C100,000\u002Fμl;\n8. History of hepatic failure (e.g., ascites, encephalopathy, or variceal bleeding) or prior hepatocellular carcinoma;\n9. Diseases or past history of the following systems or serious illnesses that the investigator considers inappropriate for participation in this trial, such as: cardiovascular system: unstable or significant cardiovascular disease, such as angina pectoris, recent episode of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or ECG abnormality, etc.; respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; endocrine and metabolic diseases: diabetes mellitus, thyroid disease poorly controlled by medication, etc.; others: autoimmune diseases, active tuberculosis, malignant diseases (e.g., tumors), history of neurological or psychiatric disorders, etc;\n10. Subjects who have participated in any drug\u002Fdevice clinical study within 3 months prior to receiving the experimental drug.\n11. History of organ transplantation (except corneal transplantation and hair transplantation).\n12. Those with alcoholism (alcohol consumption for more than 5 years prior to the screening period, with alcohol content greater than 40g per day for men and 20g per day for women) or known drug dependence.\n13. Subjects who have a birth plan or a plan to donate sperm or eggs during the screening period, during the trial, and for 6 months after the end of the trial or who are unwilling to use effective contraception.","ALL","65 Years",{"count":56,"type":21},9,[58],"PHASE1","Existing nucleoside analogues (NAs) and interferon therapy for chronic hepatitis B (CHB) have limitations, including drug resistance, low HBsAg clearance rates, and irreversible immunosuppression. Therapeutic vaccines, by activating virus-specific T cells and B cells, hold promise for achieving functional cure (HBsAg clearance + sustained HBV DNA negativity). This study is an open-label, single-arm, dose-escalation Phase I clinical trial. The study population consists of patients with chronic hepatitis B virus infection who have achieved virological stability following standard antiviral therapy. Phase I (dose exploration): three dose groups, with three patients per group. The primary objective is to observe and evaluate the safety of the WGc0201 vaccine in the study population (incidence and severity of adverse events).",[61],"Chronic Hepatitis B Virus (Hbv)",[63,64,65],"mRNA","vaccine","chronic Hepatitis B virus","RECRUITING",{"date":35,"type":36},{"date":69,"type":21},"2026-09-01",{"date":71,"type":21},"2031-09-01",{"name":42,"class":43},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":44},"100597116","phase-1-mrg003-plus-hx008-as-first-line-treatment-for-egfr-positive-locally-advanced-or-metastatic-penile-squamous-cell-carcinoma-100597116","NCT07054307","MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma","MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma: A Prospective, Single-Arm, Phase I Clinical Trial","MH-Penile-001","Inclusion Criteria:\n\n1. Histologically and\u002For cytologically confirmed unresectable, locally advanced, or metastatic penile squamous cell carcinoma.\n2. EGFR expression (defined as IHC 1+, 2+, or 3+) confirmed by the institutional pathology department using primary or metastatic tumor tissue samples.\n3. No prior systemic therapy for advanced disease.\n4. Male, aged ≥18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 with a life expectancy ≥3 months.\n6. At least one measurable lesion per RECIST 1.1 criteria.\n7. Adequate organ function (based on institutional laboratory reference ranges):\n\n   Left ventricular ejection fraction (LVEF) ≥50%.\n\n   Hematology:\n\n   Hemoglobin (HGB) ≥90 g\u002FL, White blood cell count (WBC) ≥3.0×10⁹\u002FL, Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, Platelet count (PLT) ≥80×10⁹\u002FL.\n\n   Biochemistry:\n\n   Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN), AST\u002FALT ≤2.5×ULN (≤5×ULN if liver metastases present), Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin.\n8. Willing to provide written informed consent, with full understanding of the study requirements and commitment to comply with trial procedures and follow-up visits.\n\nExclusion Criteria:\n\n1. Patients who have received prior systemic therapy before enrollment.\n2. History of other malignancies, except for cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other malignancies that have been disease-free for at least 5 years.\n3. Presence of central nervous system metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may be eligible if they have been stable for at least 6 months, show no disease progression on imaging within 4 weeks before treatment, have no neurological symptoms, demonstrate no evidence of new or enlarging brain metastases, and have discontinued radiation, surgery, or steroid therapy for brain metastases at least 28 days prior to the first dose. Carcinomatous meningitis is excluded regardless of clinical stability.\n4. Severe or uncontrolled concurrent diseases, including uncontrolled infections, active tuberculosis, uncontrolled diabetes, cardiovascular diseases (such as NYHA Class III or IV heart failure, second-degree or higher heart block, myocardial infarction within the past 12 months, unstable arrhythmia or angina, or cerebral infarction within the past 6 months), pulmonary diseases (such as interstitial lung disease, chronic obstructive pulmonary disease, or a history of symptomatic bronchospasm), deep vein thrombosis or pulmonary embolism within the past 12 months, or decompensated cirrhosis.\n5. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are permitted.\n6. Positive serological virology test results, including HIV positivity, HBsAg positivity with detectable HBV DNA (≥2000 copies\u002FmL), or HCV antibody positivity (eligible only if HCV RNA PCR-negative).\n7. Major surgery within 4 weeks before enrollment, or prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n8. Administration of or plans to receive anti-cancer vaccines within 4 weeks before enrollment or during the study.\n9. Clinically significant pleural effusion or ascites, as determined by the investigator to be unsuitable for enrollment.\n10. Any other condition considered by the investigator to make the patient ineligible for the clinical study.",{"count":82,"type":21},10,[58],"Penile squamous cell carcinoma (PSCC) is a rare malignancy, with stage IV patients exhibiting a 2-year overall survival (OS) rate of 21% and a 5-year survival rate of 0%. Both the National Comprehensive Cancer Network (NCCN) and European Association of Urology (EAU) guidelines recommend chemotherapy as the first-line treatment. However, the efficacy of chemotherapeutic agents in PSCC remains suboptimal, and options after chemotherapy failure are extremely limited. In recent years, targeted therapy and immunotherapy have demonstrated potential in treating this disease. Combination therapies based on chemotherapy, particularly chemoimmunotherapy combined with targeted therapy, have shown promising antitumor effects. Nevertheless, these regimens are associated with significant adverse effects and impose high physical demands on patients.\n\nTherefore, this study aims to explore a \"highly effective and low-toxicity\" first-line treatment regimen for advanced PSCC patients. The objective is to evaluate the combined therapeutic efficacy of an epidermal growth factor receptor (EGFR)-targeted antibody-drug conjugate (MRG003) and an immune checkpoint inhibitor (HX008) through a single-arm, phase I, prospective clinical trial.",[27],[29,30,31],"2026-03-31",{"date":89,"type":36},"2026-04-07",{"date":91,"type":36},"2026-02-12",{"date":93,"type":21},"2030-07-30",{"name":42,"class":43},""]