[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Anhui Provincial Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":420},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,39,67,92,118,141,166,191,210,227,248,267,288,309,330,354,377,399],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100641281","phase-2-a-prospective-study-of-firmonertinib-as-first-line-adaptive-therapy-guided-by-dynamic-ctdna-mrd-changes-in-locally-advanced-or-metastatic-egfr-mutated-non-small-cell-lung-cancer-100641281",false,"NCT07661173","A Prospective Study of Firmonertinib as First-line Adaptive Therapy Guided by Dynamic ctDNA (MRD) Changes in Locally Advanced or Metastatic EGFR-mutated Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Sign a written informed consent before implementing any trial-related procedures;\n* At least 18 years of age;\n* Have histologically or cytologically confirmed non-squamous non-small cell lung cancer.\n* Confirmed presence of EGFR-sensitive mutation-positive by tumor histology, cytology, hematology, or pleural effusion supernatant;\n* ECOG score of 0-1;\n* According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there must be at least one measurable lesion on imaging. Lesions located within the previous radiation field that have proven progression can be considered measurable;\n* Life expectancy \\>3 months at Day 1;\n* Patients newly diagnosed with locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) lung cancer according to the 9th edition of the TNM classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer; not suitable for treatment with surgery or radiotherapy;\n* Confirmed presence of EGFR mutation-positive by tumor histology, cytology, or hematology;\n* Not previously treated with anti-angiogenic drugs\u002Fchemotherapy;\n* Brain metastasis patients are allowed to be enrolled, as long as they meet the following conditions:\n* Sufficient organ function, and the subjects must meet the following laboratory criteria:\n\n  1. Absolute neutrophil count (ANC) ≥1.5x10\\^9\u002FL without the use of granulocyte colony-stimulating factor in the past 14 days;\n  2. Platelets ≥100×10\\^9\u002FL without blood transfusion in the past 14 days;\n  3. Hemoglobin \\>9g\u002FdL without blood transfusion or erythropoietin use in the past 14 days;\n  4. Total bilirubin ≤1.5×upper limit of normal (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (subjects with liver metastasis are allowed to have ALT or AST ≤5×ULN);\n  6. Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n  7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN;\n  8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled;\n  9. myocardial enzyme profile within the normal range (subjects with simple laboratory abnormalities that the investigator comprehensively judges to have no clinical significance are also allowed to be enrolled);\n* For female subjects of childbearing age, urine or serum pregnancy tests must be conducted within 3 days before the first dose of study drug (on Day 1 of Cycle 1) and the results must be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing age females are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;\n* If there is a risk of pregnancy, all subjects (regardless of gender) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).\n\nExclusion Criteria:\n\n* The pathology is small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and non-small cell lung cancer (NSCLC);\n* The patient has received the following treatments:\n\n  1. received systemic anti-tumor therapy within 3 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indications), etc.;\n  2. received any investigational drug therapy within 4 weeks before treatment;\n  3. received high-dose immunosuppressive drugs (systemic glucocorticoids exceeding 10mg\u002Fday of prednisone or its equivalent dose) within 4 weeks before treatment;\n  4. received attenuated live vaccines within 4 weeks before treatment (or plans to receive attenuated live vaccines during the study period);\n  5. underwent major surgery (such as thoracotomy, thoracotomy, or Kaifu surgery) within 4 weeks before treatment, or has unhealed surgical wounds, ulcers, or fractures.\n* Subjects with clinically uncontrollable pleural\u002Fperitoneal effusion (not requiring drainage of effusion or showing no significant increase in effusion after 3 days of cessation of drainage) may be enrolled;\n* Subjects with a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid treatment, or any evidence of clinically active ILD;\n* Subjects who have received chest radiotherapy exceeding 30 Gy within 6 months prior to treatment or palliative radiotherapy of 30 Gy or less within 7 days prior to treatment (palliative radiotherapy for bone or intracranial lesions is allowed);\n* Subjects who have experienced active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;\n* Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* Subjects who have not fully recovered from toxicity and\u002For complications caused by any intervention prior to the start of treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia);\n* Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive);\n* Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the research center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: 1) HBV viral load \\\u003C1000 copies\u002Fml (200 IU\u002Fml) prior to the first dose, and subjects should receive anti-HBV treatment throughout the study drug treatment period to avoid viral reactivation; 2) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV treatment is not required, but close monitoring for viral reactivation is necessary.\n* Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit);\n* Subjects who have received a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated virus vaccine for seasonal influenza administered via injection is allowed within 30 days prior to the first dose; however, attenuated live influenza vaccine administered intranasally is not allowed.\n* Pregnant or lactating women;\n* Subjects with any severe or uncontrollable systemic diseases, such as:\n\n  1. significant and symptomatically severe abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation;\n  2. unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification of ≥ 2;\n  3. myocardial infarction within 6 months prior to enrollment;\n  4. poorly controlled blood pressure (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg);\n  5. history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease;\n  6. active tuberculosis;\n  7. active or uncontrollable infections requiring systemic treatment;\n  8. clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;\n  9. liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n  10. poorly controlled diabetes (fasting blood glucose (FBG) \\>10 mmol\u002FL);\n  11. urine routine test indicating proteinuria ≥++ and confirmed 24-hour urine protein quantitation \\>1.0 g;\n  12. subjects with mental disorders and unable to cooperate with treatment; subjects with medical history or disease evidence, treatment, or laboratory test values that may interfere with trial results, hinder the subject's full participation in the study, or other situations deemed unsuitable for enrollment by the investigator; subjects deemed by the investigator to have other potential risks and are not suitable to participate in this study","ALL","18 Years",{"count":18,"type":19},154,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Exploring the efficacy and safety of adaptively adjusting treatment regimens based on ctDNA (MRD) status for EGFR mutation-positive NSCLC",[25],"Non Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-06-18",{"date":29,"type":30},"2026-06-22","ACTUAL",{"date":32,"type":19},"2026-06-06",{"date":34,"type":19},"2031-05-06",{"name":36,"class":37},"Anhui Provincial Cancer Hospital","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":38},"100637833","phase-2-becotatug-vedotin-combined-with-pucotenlimab--radiotherapy-as-first-line-treatment-for-driver-gene-negative-egfr-expression-positive-advanced-non-small-cell-lung-cancer-100637833","NCT07627321","Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer","PRAD2: A Prospective, Single-Arm, Multi-Center, Exploratory Study of Becotatug Vedotin Combined With Pucotenlimab ± Radiotherapy as First-Line Treatment for Driver-Gene-Negative, EGFR-Expression-Positive Advanced Non-Small Cell Lung Cancer","PRAD2","Inclusion Criteria:\n\n1. Voluntary participation with written informed consent obtained prior to any study-specific procedures, and willingness to comply with the study requirements.\n2. Male or female patients aged between 18 and 75 years (inclusive) at the time of signing informed consent.\n3. Histologically or cytologically confirmed Stage IV (M1a, M1b, or M1c according to the AJCC 8th Edition) squamous or non-squamous NSCLC.\n4. No prior systemic therapy for advanced\u002Fmetastatic disease is permitted. Patients who received adjuvant\u002Fneoadjuvant chemotherapy and relapsed ≥6 months after the last dose are allowed to enroll.\n5. At baseline, presence of at least one measurable target lesion outside the primary tumor per RECIST v1.1, which is suitable for accurate repeated measurement and has not been previously irradiated or treated with other local therapies.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Absence of known actionable driver gene alterations (e.g., EGFR, ALK, ROS1) in both squamous and non-squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory.\n8. Immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher.\n9. Medically fit to tolerate radiotherapy, with an expected survival of ≥12 weeks.\n10. No prior exposure to Antibody-Drug Conjugates (ADCs).\n11. Adequate organ and bone marrow function as defined below (within 14 days prior to initiation of study treatment):\n\n    \\- Hematology (must not have received blood transfusions, granulocyte colony-stimulating factor \\[G-CSF\\], or hematopoietic growth factors within 14 days prior to screening):\n\n    \\- Hemoglobin (Hb) ≥ 90 g\u002FL;\n\n    \\- Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n\n    \\- Platelets (PLT) ≥ 75 × 10⁹\u002FL.\n\n    \\- Blood Chemistry (must not have received albumin infusion within 14 days prior to screening):\n    * Total Bilirubin (TBIL) ≤ 2.0 × ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome);\n    * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 5.0 × ULN;\n    * Serum Creatinine (Cr) ≤ 1.5 × ULN or Calculated Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula):\n\n    Male: CrCl = ((140 - age) × weight) \u002F (72 × serum creatinine) Female: CrCl = ((140 - age) × weight) \u002F (72 × serum creatinine) × 0.85 (Note: Weight in kg; Serum creatinine in mg\u002FdL)\n\n    \\- Coagulation Function:\n    * International Normalized Ratio (INR) ≤ 2.0 or Prothrombin Time (PT) ≤ 6 seconds above the upper limit of normal.\n12. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the first dose. If the urine test cannot be definitively confirmed as negative, a serum pregnancy test must be performed, and the serum result will be considered definitive.\n13. Female subjects of childbearing potential who are sexually active with unsterilized male partners must agree to use highly effective contraception starting at screening and continue for 180 days after the last dose of study drug.\n14. Sexually active male subjects who have not undergone sterilization and who are sexually active with female partners of childbearing potential must agree to use effective contraception starting at screening and continue for 180 days after the last dose. Decisions regarding the cessation of contraception beyond this timeframe should be discussed with the investigator.\n15. Subjects must be willing and able to comply with scheduled visits, the treatment plan, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1\\. Prior receipt of any systemic anti-tumor therapy for advanced, recurrent, or metastatic NSCLC, or perioperative therapy completed less than 6 months prior to enrollment.\n\n2\\. History of another malignancy within 5 years prior to enrollment (excluding cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n\nKnown hypersensitivity to Becotatug vedotin, Pucotenlimab, or any of their excipients.\n\n3\\. Prior treatment with any of the following: ADCs, PD-1\u002FPD-L1 inhibitors, CTLA-4 inhibitors, or bispecific antibodies targeting immune checkpoints.\n\n5\\. History of severe bleeding tendency or coagulation dysfunction; significant clinically significant bleeding symptoms within 1 month prior to the first dose (including but not limited to gastrointestinal bleeding, hemoptysis \\[defined as expectoration of ≥1 teaspoon of fresh blood or blood clots, or pure hemoptysis without sputum; subjects with blood-streaked sputum are allowed\\]); nasal hemorrhage (excluding simple epistaxis and post-nasal drip with blood); imaging at screening showing tumor encasement of major vessels, significant tumor necrosis, or cavitation deemed by the investigator to pose a high bleeding risk; central or cavitary squamous NSCLC deemed high-risk for bleeding by the investigator; receipt of continuous antiplatelet or anticoagulant therapy within 10 days prior to the first dose.\n\n6\\. Tumor invasion of surrounding vital organs or vessels (e.g., aorta, heart and pericardium, superior vena cava, trachea, esophagus) or presence of risk factors for esophagotracheal fistula or esophagopleural fistula.\n\n7\\. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (subjects not requiring drainage or requiring drainage less than once per month are allowed).\n\n8\\. Arteriovenous thromboembolic events within 6 months prior to randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except those judged by the investigator to be fully resolved and related to venous catheters for prior chemotherapy), and pulmonary embolism.\n\n9\\. Symptomatic brain metastases. Subjects with brain metastases that have been treated and remain clinically stable for at least 1 month, and who have discontinued corticosteroids and anticonvulsants for at least 1 month prior to study entry, are allowed.\n\n10\\. Inability to provide documentation of driver gene-negative status or IHC evidence confirming EGFR expression ≥2+.\n\nComorbidities\u002FMedical History:\n\n11\\. Hypertension that cannot be adequately controlled with antihypertensive medication (systolic BP \\>140 mmHg or diastolic BP \\>90 mmHg);\n\n\\- Within 6 months prior to randomization: myocardial infarction, severe\u002Funstable angina, NYHA Class II or greater cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure;\n\n* Conditions significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or clinically significant intestinal obstruction;\n* Renal insufficiency: urinalysis indicating proteinuria ≥++, or confirmed 24-hour urine protein ≥1.0 g;\n* Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); active hepatitis (Hepatitis B defined as HBV-DNA ≥ 500 IU\u002FmL; Hepatitis C defined as HCV-RNA above the lower limit of detection) or co-infection with Hepatitis B and C;\n* Presence of any active autoimmune disease or history thereof (including but not limited to autoimmune hepatitis, enteritis, vasculitis, nephritis; subjects requiring bronchodilator therapy for asthma are excluded); however, subjects with vitiligo, psoriasis, alopecia not requiring systemic treatment, or well-controlled Type 1 diabetes are allowed;\n* Severe infection within 4 weeks prior to the first dose, including but not limited to bacteremia or severe pneumonia requiring hospitalization; active infection requiring systemic antibiotics within 2 weeks prior to the first dose (CTCAE Grade ≥2); fever \\>38.5°C of unknown origin during screening\u002Fprior to first dose (fever due to tumor progression judged by the investigator is allowed); evidence of active tuberculosis infection within 1 year prior to dosing.\n\n  12\\. Major surgery within 28 days prior to the first dose (diagnostic tissue biopsy, PICC line placement, or PORT placement are allowed).\n\n  13\\. Prior allogeneic bone marrow transplantation or solid organ transplantation.\n\n  14\\. History of substance abuse or psychiatric disorders that cannot be controlled or withdrawn.\n\n  15\\. History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, organ transplantation, or allogeneic bone marrow transplantation.\n\n  16\\. Currently participating in another interventional clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.\n\n  17\\. Pregnant or lactating women. 18. Any other condition that, in the investigator's judgment, would compromise the subject's safety, hinder compliance, or necessitate premature study termination (e.g., severe concomitant illness, alcoholism, drug abuse, or social\u002Ffamilial circumstances).","75 Years",{"count":49,"type":19},39,[22],"This prospective, single-arm, exploratory multicenter clinical study aims to investigate the safety and efficacy of Becotatug vedotin combined with Pucotenlimab (with or without radiotherapy), followed by Pucotenlimab maintenance therapy, in patients with driver gene-negative (e.g., EGFR, ALK, ROS1), EGFR-overexpressing non-small cell lung cancer (NSCLC).\n\nStudy Population:\n\nThe study targets patients with driver gene-negative (EGFR, ALK, ROS1, and other actionable targets) non-squamous and squamous NSCLC. All subjects (regardless of smoking history) must provide testing reports for EGFR, ALK, and ROS1. If no prior report exists, baseline biopsy or submission of archived tissue for assessment of driver gene status (via local or central laboratory) is mandatory. Additionally, eligible patients must have an immunohistochemistry (IHC)-confirmed EGFR expression level of 2+ or higher, be previously untreated with systemic therapy for stage IV NSCLC, have measurable lesions, show no active central nervous system metastases or uncontrolled autoimmune diseases, and voluntarily sign the informed consent form.\n\nTreatment Regimen:\n\nSubjects meeting the inclusion\u002Fexclusion criteria will receive the following treatment regimen:\n\nPucotenlimab (HX008): Administered from Cycle 1 to Cycle 4 at a dose of 3 mg\u002Fkg (maximum 200 mg), once every 3 weeks on Day 1 (D1). Intravenous infusion (60 ± 15 minutes; first cycle infusion duration not less than 60 minutes).\n\nBecotatug vedotin (MRG003): Administered from Cycle 1 to Cycle 4 at a dose of 2.0 mg\u002Fkg, once every 3 weeks on D1. Administration begins at least 30 minutes after the completion of Pucotenlimab infusion. Intravenous infusion (60 ± 10 minutes; first cycle infusion duration not less than 60 minutes).\n\nRadiotherapy: Investigators may opt to include sequential radiotherapy based on tumor size, number, location, extent of invasion, and individual patient factors. Radiotherapy options are as follows:\n\nTarget Volume: Radiotherapy commences 2 weeks (±7 days) after the completion of Cycle 4 treatment, targeting only the primary tumor or specific 1-2 metastatic lesions.\n\nFractionation and Dosage:\n\nConventional Fractionation Group: Applicable for larger target volumes (\\>5 cm diameter) or involvement of mediastinal lymph nodes. Total dose: 45-60 Gy; single fraction dose: 1.8-2.0 Gy; administered once daily (Qd).\n\nStereotactic Body Radiotherapy (SBRT) Group: Applicable for oligometastatic lesions (≤3 lesions, each ≤3 cm diameter). Total dose: 30-50 Gy delivered in 3-5 fractions; single fraction dose: 6-10 Gy.\n\nMaintenance Therapy: Pucotenlimab (HX008) monotherapy until disease progression (defined by RECIST 1.1), investigator-assessed radiographic progression, unacceptable toxicity, withdrawal of consent, or fulfillment of criteria for discontinuation of intervention.",[53],"NSCLC (Advanced Non-small Cell Lung Cancer)",[55,56,57,58],"Becotatug vedotin","Pucotenlimab","Sequential radiotherapy","Driver gene-negative NSCLC","2026-06-01",{"date":61,"type":30},"2026-06-04",{"date":63,"type":19},"2026-07-15",{"date":65,"type":19},"2029-07-16",{"name":36,"class":37},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":74,"minAge":16,"maxAge":47,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":38},"100638147","super-resolution-ultrasound-imaging-for-assessing-response-to-neoadjuvant-chemotherapy-in-breast-cancer-100638147","NCT07623226","Super-Resolution Ultrasound Imaging for Assessing Response to Neoadjuvant Chemotherapy in Breast Cancer","Value of Super-Resolution Ultrasound Imaging in Assessing Response to Neoadjuvant Chemotherapy for Breast Cancer: A Prospective Observational Study","Inclusion Criteria\n\n1. Age and Gender: Female patients aged 18 to 75 years.\n2. Diagnosis: Histologically confirmed invasive breast cancer via core needle biopsy.\n3. Treatment Plan: Scheduled to receive standard neoadjuvant chemotherapy at our institution.\n4. Imaging: The lesion is clearly visible on baseline ultrasound. Consent: Willing to participate in the study and sign the written informed consent form.\n\nExclusion Criteria\n\n1. Prior Treatment: History of any prior treatment for ipsilateral breast cancer (e.g., surgery, radiotherapy, chemotherapy, or targeted therapy).\n2. Other Malignancies: Presence of other active malignancies.\n3. Pregnancy\u002FLactation: Pregnant or breastfeeding women.\n4. Health Status: Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders that preclude cooperation with the examination.\n5. Image Quality: Poor ultrasound image quality that prevents SR-US analysis.","FEMALE",{"count":76,"type":19},150,"OBSERVATIONAL","1. Study Design Overview Study Type: Single-center, prospective, observational, diagnostic study. Primary Objective: To validate whether Super-Resolution Ultrasound Imaging (SRUS) can accurately predict pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast cancer at an early stage (after the first cycle of chemotherapy).\n\n   Sample Size: A total of 150 patients are planned to be enrolled. Study Period: March 2026 - March 2028.\n2. Core Methodology: Cohort Allocation This study employs a classic \"Model Development-Validation\" cohort design to construct a predictive model and verify its generalizability.\n\n   Allocation Method: Systematic random allocation. Allocation Ratio: 7:3. Randomization: Patients will be assigned based on the sequence of enrollment using a computer-generated random sequence.\n\n   Blinding Principle: Allocation information will be concealed (blinded) from patients and the clinical treatment team. Only the research coordinators and statisticians will have access to the grouping data to prevent information leakage.\n\n   Validation Set (Independent Validation Cohort): Comprising 30% of the sample (45 cases). The data will remain \"sealed\" until model construction is finalized. It will be used for unbiased, objective performance evaluation of the final model (e.g., calculating AUC, sensitivity).\n3. Study Procedures and Visits\n\n   The study workflow strictly adheres to the chemotherapy timeline, with core data collection points focused on the early phase of treatment:\n\n   V0 (Screening): Confirmation of eligibility criteria. V1 (Baseline, Pre-chemotherapy): Initial SRUS examination to acquire baseline tumor data.\n\n   V2 (Early Visit, 48-72 hours after the 1st cycle): The critical data point for the predictive model; the first follow-up examination.\n\n   V3 (Mid-term Visit, Pre-4th cycle): The second follow-up examination. V4 (Surgery, 3-4 weeks after the last cycle): Radical surgery is performed. V5 (Endpoint Assessment, 2-4 weeks post-surgery): Acquisition of pathological results to confirm pCR status (the gold standard).\n4. Key Technology and Statistics Key Technology: The Mindray Resona A20 ultrasound system will be used in conjunction with Sulfur Hexafluoride (SF6) microbubble contrast agents to extract quantitative parameters such as tumor microvascular density and blood volume.\n\n   Statistical Analysis:\n\n   In the Training Set: LASSO regression will be used for feature selection to construct a logistic regression predictive model.\n\n   In the Validation Set: The formula derived from the training set will be directly applied to calculate the Area Under the ROC Curve (AUC), calibration curves, and other metrics to evaluate model performance.\n5. Eligibility Criteria Inclusion Criteria: Females aged 18-75, histologically confirmed invasive breast cancer, scheduled for standard neoadjuvant chemotherapy, with lesions clearly visible on baseline ultrasound.\n\nExclusion Criteria: History of prior breast cancer treatment (surgery, radiotherapy, chemotherapy), presence of other active malignancies, pregnancy or lactation, severe organ dysfunction, or poor image quality.",[80],"Breast Cancer",[82,83,84],"breast cancer","neoadjuvant chemotherapy","Super resolution ultrasound imaging","2026-05-28",{"date":87,"type":30},"2026-06-03",{"date":59,"type":19},{"date":90,"type":19},"2028-07-01",{"name":36,"class":37},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":20,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":38},"100607940","to-explore-the-safety-and-efficacy-of-hypervision-proton-surgery-for-early-stage-non-small-cell-lung-cancer-100607940","NCT07195084","To Explore the Safety and Efficacy of Hypervision Proton Surgery for Early-stage Non-small Cell Lung Cancer","A Phase I Clinical Study to Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer","HyPROS-LC","Inclusion Criteria:\n\n* The patient must be at least 18 years old\n* Karnofsky Performance Status \\> 80\n* NSCLC confirmed by cytology or histology; for subjects who cannot safely obtain pathological evidence due to factors such as tumor lesion location, patient's underlying diseases, or high puncture risk, after unanimous consent of the multidisciplinary team (MDT) discussion, they meet the clinical diagnostic criteria for NSCLC based on typical imaging features (such as enhanced chest CT and\u002For PET\u002FCT) combined with clinical manifestations;\n* Early-stage tumors are defined as T1 (≤3cm) N0M0 based on enhanced computed tomography (CT) and positron emission tomography (PET)\n* The tumor must be more than 2 cm away from the proximal bronchial tree in all directions (the proximal bronchial tree is defined as 2 cm from the distal end of the trachea, the protrusion and the named lobar bronchus up to its first bifurcation)\n* FEV1 ≥ 1 L, FEV1 ≥ 40% of the predicted value (either one is sufficient); DLCO ≥ 40% of the predicted value\n* The patient can tolerate PET-CT examination\n* For female study participants of childbearing age, the urine or serum pregnancy test was negative within 7 days prior to the first administration of the study drug. If the result of the urine pregnancy test is positive, a blood pregnancy test is required\n\nExclusion Criteria:\n\n* Other malignant tumors occurred concurrently within 2 years before enrollment\n* A history of chest radiotherapy in the past\n* It is planned to use other anti-tumor treatments within the regimen treatment (within 4 weeks)",{"count":101,"type":19},12,[103],"NA","This study was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.",[106],"Non-Small Cell Lung Cancer",[108],"non-small cell lung cancer; Hypervision proton surgery","RECRUITING","2026-04-07",{"date":112,"type":30},"2026-04-13",{"date":114,"type":30},"2025-09-20",{"date":116,"type":19},"2028-09-19",{"name":36,"class":37},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":124,"targetDuration":4,"studyType":20,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":4},"100621534","a-prospective-single-arm-exploratory-study-of-trifluridinetipiracil-tas-102-combined-with-apatinib-as-third-line-therapy-for-advanced-gastric-cancer-100621534","NCT07371871","A Prospective, Single-arm, Exploratory Study of Trifluridine\u002FTipiracil (TAS-102) Combined With Apatinib as Third-line Therapy for Advanced Gastric Cancer","Inclusion Criteria:\n\n* Gastric cancer confirmed by histopathological or cytological diagnosis;\n* unresectable locally advanced or recurrent\u002Fmetastatic gastric cancer;\n* age 18-75 years, regardless of gender;\n* ECOG score 0-2;\n* previously received second-line treatment for advanced gastric cancer with disease progression during or after treatment;\n* at least one measurable lesion present according to RECIST 1.1 criteria;\n* laboratory tests meeting the following requirements: (1) Blood routine: HGB≥70g\u002FL; WBC≥4.0×10\\^9\u002FL; NEUT≥1.5×10\\^9\u002FL; PLT≥90×10\\^9\u002FL; (2) Blood biochemistry: ALT, AST≤2.5×upper limit of normal (ULN), serum creatinine≤1.5×upper limit of normal;\n* negative pregnancy test for patients of childbearing potential and voluntary use of effective and reliable contraception during the trial.\n\nExclusion Criteria:\n\n* Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment;\n* Any of the following conditions that may interfere with oral medication: inability to swallow, chronic diarrhea, or intestinal obstruction;\n* Concurrent receipt of any other systemic anti-tumor therapy (excluding local treatment);\n* Previous treatment with VEGFR inhibitors (excluding ramucirumab; pan-targeted TKIs are excluded);\n* Known history of allergy to any component of the study drugs;\n* Subjects with active infectious diseases;\n* Patients deemed unsuitable for enrollment by the investigator due to potential increased study-related risks or possible interference with interpretation of study results, as assessed by the investigator.",{"count":125,"type":19},30,[103],"To evaluate the efficacy and safety of trifluridine\u002Ftipiracil (TAS-102) combined with apatinib as third-line therapy for advanced gastric cancer",[129],"Advanced Gastric Cancer",[129,131,132],"TAS-102","Apatinib","2026-01-19",{"date":135,"type":30},"2026-01-28",{"date":137,"type":19},"2026-01-08",{"date":139,"type":19},"2028-12-31",{"name":36,"class":37},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":15,"minAge":16,"maxAge":149,"enrollmentInfo":150,"targetDuration":152,"studyType":77,"phases":4,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":38},"100619900","noninvasive-real-time-arterial-waveform-monitoring-for-cardiovascular-disease-assessment-100619900","NCT07350629","Noninvasive Real-Time Arterial Waveform Monitoring for Cardiovascular Disease Assessment","A Study on Noninvasive Real-Time Arterial Pressure Waveform Analysis for the Detection and Evaluation of Cardiovascular Diseases","Inclusion Criteria:\n\n* Age 18-80 years\n* Able to provide informed consent\n* For AR group: clinically diagnosed aortic regurgitation\n* For AS group: clinically diagnosed aortic stenosis\n* For healthy controls: no history of cardiovascular disease\n* Able to undergo finger arterial waveform measurement\n\nExclusion Criteria:\n\n* History of recent cardiac surgery or intervention (\\\u003C6 months)\n* Hand disorders affecting finger mobility (e.g., arthritis)\n* Pregnant or breastfeeding women\n* Participation in other studies affecting arterial waveform\n* Unable to understand or comply with study procedures",true,"80 Years",{"count":151,"type":19},15,"1 Day","The goal of this observational study is to learn whether noninvasive real-time arterial waveform monitoring can be used to assess cardiovascular diseases in adults. The main question it aims to answer is:\n\nCan photoacoustic imaging accurately capture arterial waveforms from patients' fingers? Can features extracted from the arterial waveforms reflect the type and severity of cardiovascular diseases? Participants will be asked to place their fingers into the imaging device, where their finger arterial pulse information will be noninvasively recorded.",[155,156,157],"Aortic Regurgitation Disease","Aortic Stenosis Disease","Healthy Subjects","2026-01-11",{"date":160,"type":30},"2026-01-20",{"date":162,"type":30},"2025-12-26",{"date":164,"type":19},"2026-02",{"name":36,"class":37},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":173,"targetDuration":4,"studyType":20,"phases":175,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":38},"100618359","phase-2-ql1706-combined-with-chemotherapy-in-the-treatment-of-immune-mediated-nsclc-100618359","NCT07330596","QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated NSCLC","A Randomized Controlled Study Comparing the Efficacy of QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Voluntarily participate in the research and sign an informed consent form; Age ≥ 18 years old, ≤ 75 years old;\n* Diagnosed with NSCLC through histology or cytology;\n* No EGFR sensitive mutations or ALK gene translocation changes;\n* Previously received PD-1\u002FPD-L1 inhibitors combined with platinum based dual therapy or sequential therapy as first-line treatment for advanced metastatic or recurrent NSCLC, and disease progression occurred during or after treatment; At least one measurable lesion should be used as the target lesion (RECIST v1.1 standard);\n* ECOG score: 0-2 points;\n* Expected survival period is not less than 12 weeks;\n* Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 28 days before enrollment, and voluntarily use appropriate contraception methods during the observation period and within 8 weeks after the last dose; For males, surgical sterilization or consent to use appropriate contraception methods during the observation period and within 8 weeks after the last dose should be provided;\n* The laboratory test results during the screening period indicate that the patient has good organ function: a) Hematology (no blood transfusion within 14 days and no treatment with blood components or granulocyte colony-factor): Neutrophil count (NEU) ≥ 1.5 × 10 \\^ 9\u002FL (1500\u002Fmm3); Platelet count (PLT) ≥ 100 × 10 \\^ 9\u002FL (100000\u002Fmm3); Hemoglobin ≥ 90 g\u002FL; b) Liver: serum total bilirubin (TBil) ≤ ULN; Glutamate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 × ULN; AST or ALT should be 1.5-3.5 × ULN, and alkaline phosphatase (ALP) should be ≤ 2.5 × ULN; c) Kidney: creatinine clearance rate (CrCl) calculated value ≥ 30 mL\u002Fmin; d) Coagulation function: International normalized ratio (INR) ≤ 1.5, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; j) International Normalized Ratio (INR) ≤ 1.5; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n* Patients whom researchers believe can benefit.\n\nExclusion Criteria:\n\n* There are EGFR sensitive mutations or ALK gene translocation changes present;\n* Previously received PD1\u002FCTLA4 bispecific antibody therapy;\n* Adverse reactions caused by previous treatment have not recovered to CTCAE (version 5.0) grade 1 or below (excluding toxicity ≤ grade 2 that has been determined by the researcher to exist for a long time, cannot be recovered, and does not increase safety risks);\n* Symptomatic central nervous system metastasis. Patients who have received treatment for brain metastases and have been deemed stable by researchers may consider participating in this study;\n* For patients with poor control of cancer-related pain, those who require analgesic treatment must receive a stable dose of treatment before participating in the study;\n* Chest fluid, ascites or pericardial effusion with clinical symptoms or unstable condition after symptomatic treatment;\n* Known to have a history of severe allergic reactions to the drug and its components, planned chemotherapy drugs, and those with a history of severe allergic reactions;\n* Suffering from or suspected of active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory intestinal diseases, etc., except: type I diabetes and hypothyroidism that can be controlled through stable dose replacement treatment, and skin diseases that do not require systemic treatment (such as psoriasis, vitiligo);\n* History of interstitial lung disease or drug-induced interstitial lung disease or pneumonia in the past;\n* Corticosteroid drugs (prednisone\\>10mg\u002Fday or equivalent dose) or other immunosuppressive drugs received systemically within 14 days prior to the first study medication;\n* Individuals with a history of immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, those with a history of organ transplantation, or those who have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation; Received live vaccination within 4 weeks before the first study medication;\n* Suffering from serious cardiovascular and cerebrovascular diseases: a) poorly controlled hypertension or pulmonary arterial hypertension; b) Unstable angina or myocardial infarction, coronary artery bypass grafting or stent implantation within 6 months prior to study medication; c) Chronic heart failure with heart function ≥ 2 (NYHA classification by the New York Heart Association); d) Left ventricular ejection fraction (LVEF)\\\u003C50%; e) Various severe arrhythmias requiring medication treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia). For example, male QTcF\\>450 milliseconds or female QTcF\\>470 milliseconds, complete left bundle branch block, grade III block; f) Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months prior to the study medication;\n* Positive result of human immunodeficiency virus (HIV) antibody test, active hepatitis B or C. The following conditions are allowed to participate in this study: a) hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) is positive, but HBV DNA is lower than the lower limit of the detection value of the research center (negative) or less than 500IU\u002FML, and the active infection is excluded according to the judgment of the researcher based on clinical treatment and performance; b) Individuals with positive hepatitis C antibodies and HCV RNA below the lower limit (negative) of the detection value at the research center;\n* Suffering from other active malignant tumors other than the research disease within 5 years, except for malignant tumors that can be expected to recover after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell carcinoma, or breast ductal carcinoma in situ treated with radical surgery);\n* Individuals with a history of substance abuse and inability to quit, or those with a history of mental disorders;\n* Pregnant or lactating women;\n* The researcher believes that the patient is not suitable to participate in any other circumstances of this study.",{"count":174,"type":19},96,[22],"Lung cancer is the leading cause of cancer-related deaths worldwide. According to the 2023 global cancer statistics, there are approximately 2.47 million new cases and 1.76 million deaths of lung cancer annually, accounting for 18.4% of all cancer deaths. Among them, driver gene negative NSCLC accounts for about 30% -40% of all NSCLC. In China, the incidence rate and mortality of lung cancer rank first. In 2022, there will be about 870000 new cases and 760000 deaths. In Chinese NSCLC patients, the EGFR mutation rate is about 50%, ALK fusion is about 5%, other mutations (ROS1, RET, etc.) are about 5% -10%, and the negative proportion of driver genes is about 30% -40%. Traditional treatment for late stage non-small cell lung cancer with negative driver genes has limited clinical efficacy. In recent years, the emergence of immune checkpoint inhibitors (ICIs) has greatly changed the treatment pattern of advanced non-small cell lung cancer patients, significantly prolonging the overall survival of advanced cancer patients. For the follow-up treatment of patients with previous immunotherapy, the current standard treatment regimen is still mainly chemotherapy. However, these plans have mediocre efficacy and significant side effects, making it difficult to meet the current clinical treatment needs. At present, there is no unified treatment plan for first-line immunotherapy or immunotherapy combined with chemotherapy in patients with driver gene negative advanced NSCLC. Second line chemotherapy such as docetaxel is currently recommended as the standard treatment plan in NCCN guidelines and CSCO guidelines. Research suggests that for patients with first-line immune resistance or immune combined chemotherapy resistance, second-line immune re challenge can still bring certain survival benefits to patients, but the benefits are limited and new treatment options need to be explored.\n\nIparomlimab injection (drug number QL-1706) is a novel combination antibody independently developed by Qilu Company. It consists of Iparomlimab, an IgG4 antibody targeting PD-1, and Tuvonralimab, an IgG1 antibody targeting CTLA-4, in a fixed ratio. It has a synergistic mechanism of simultaneously blocking PD-1 and CTLA-4. In summary, ICIs are still an important treatment strategy for advanced non-small cell lung cancer. However, the emergence of drug resistance after immunotherapy seriously affects the survival time and prognosis of patients. Preliminary research has been conducted on the resistance mechanism of immunotherapy, but more research is needed to clarify the main mechanisms of action, in order to further prevent and overcome drug resistance. QL1706 has shown promising preliminary efficacy and good tolerability in PD-1 resistant NSCLC in preclinical and phase I clinical studies. Based on this, this study aims to conduct an exploratory study on QL1706 combined with chemotherapy compared to chemotherapy alone in the treatment of immune regulated non-small cell lung cancer with negative driver genes.",[53],[179,180,181,182],"NSCLC","Immune resistance","PD-1\u002FCTLA-4","EGFR\u002FALK Mutation Negative","2025-12-29",{"date":185,"type":30},"2026-01-09",{"date":187,"type":30},"2025-10-30",{"date":189,"type":19},"2028-02-28",{"name":36,"class":37},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":197,"targetDuration":4,"studyType":20,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100615998","phase-2-an-exploratory-study-of-pertuzumab-and-trastuzumab-in-combination-with-palbociclib-and-exemestane-as-neoadjuvant-therapy-for-triple-positive-breast-cancer-100615998","NCT07299890","An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast Cancer","Inclusion Criteria:\n\n* The patient must meet all of the following criteria to be included in the study:\n\n  1. The tumor stage must be in accordance with the 8th edition of the AJCC standard, being stage II-III for the initial diagnosis;\n  2. Pre-menopausal or perimenopausal patients (if this is the case, combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or post-menopausal patients;\n  3. All patients must have been pathologically confirmed as HR+\u002FHER2 receptor positive. The estrogen receptor (ER) is positive (\\>10%), the progesterone receptor (PR) is positive (\\>1%), and the HER2 receptor is positive. Follow the 2018 ASCO-CAP HER2 positive interpretation guideline standards. The immunohistochemistry (IHC) score is 3+ or 2+ and the in situ hybridization (ISH) test is positive (ISH amplification rate ≥ 2.0);\n  4. Age 18-75 years (inclusive of 18 and 75), female;\n  5. ECOG score 0-1;\n  6. Expected survival time ≥ 12 weeks;\n  7. According to the RECIST 1.1 standard, there must be at least one measurable lesion;\n  8. The functional level of organs must meet the following requirements: (a) Blood routine: ANC ≥ 1.5×109\u002FL; PLT ≥ 90×109\u002FL; Hb ≥ 90g\u002FL; (b) Blood biochemistry: TBIL ≤ 1.5×ULN; ALT and AST ≤ 3×ULN; BUN and Cr ≤ 1.5×ULN and creatinine clearance rate ≥ 50 mL\u002Fmin; (c) Cardiac echocardiography: Left ventricular ejection fraction ≥ 50%:\n  9. The subject voluntarily joins this study, signs the informed consent, has good compliance and is willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* If the patient meets any of the following conditions, they will not be eligible:\n\n  1. Has received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);\n  2. Is concurrently receiving other anti-tumor drug treatments;\n  3. Stage IV breast cancer;\n  4. Breast cancer without pathological tissue diagnosis;\n  5. Has had other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n  6. Patients with severe dysfunction of important organs such as heart, liver, and kidney;\n  7. Unable to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting the administration and absorption of the drugs;\n  8. Participated in other drug clinical trials within 4 weeks before enrollment;\n  9. Has a history of immunodeficiency diseases, including positive HIV test, HCV, active viral hepatitis or other acquired or congenital immune deficiency diseases, or a history of organ transplantation;\n  10. Has a known history of allergic reaction to the components of this drug regimen;\n  11. Has had any heart diseases, including: requiring drug treatment or clinically significant arrhythmia; myocardial infarction; heart failure; any other heart diseases judged by the researcher as unsuitable for participation in this trial;\n  12. Pregnant or lactating female patients, female patients with reproductive capacity and positive baseline pregnancy test results;\n  13. According to the investigator's judgment, there are serious accompanying diseases that endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.);\n  14. Has a clear history of neurological or mental disorders, including epilepsy or dementia;\n  15. The investigator considers that the patient is not suitable for participating in this study in any other circumstances.",{"count":198,"type":19},90,[22],"This study is a prospective, multicenter, single-arm, exploratory study. A total of 90 patients with early\u002Flater-stage triple-positive breast cancer who were scheduled to receive neoadjuvant therapy were recruited. They received neoadjuvant treatment with trastuzumab, pertuzumab, palbociclib, and exemestane in combination. The aim of this study is to evaluate the efficacy and safety of the neoadjuvant treatment regimen of trastuzumab-pertuzumab combined with palbociclib and exemestane in triple-positive breast cancer.",[80],"2025-12-10",{"date":204,"type":30},"2025-12-23",{"date":206,"type":19},"2025-12-20",{"date":208,"type":19},"2027-11-01",{"name":36,"class":37},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":216,"targetDuration":4,"studyType":20,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":226,"locationsCount":4},"100608141","phase-2-a-phase-ii-exploratory-study-of-iparomlimab-and-tuvonralimab-combined-with-chemotherapy-in-neoadjuvant-treatment-of-hrher2--breast-cancer-patients-100608141","NCT07197697","A Phase II Exploratory Study of Iparomlimab and Tuvonralimab Combined With Chemotherapy in Neoadjuvant Treatment of HR+\u002FHER2- Breast Cancer Patients","Inclusion Criteria:\n\n* The patient must meet all of the following criteria to be included in the study:\n\n  1. Age ≥ 18 years and ≤ 75 years, regardless of gender;\n  2. The primary lesion tissue pathology is confirmed as HR+\u002FHER2- breast cancer, following the 2018 ASCO\u002FCAP breast cancer HER2 testing guidelines and the 2010 ASCO\u002FCAP breast cancer ER\u002FPR testing guidelines for interpretation. HER2-negative is defined as confirmed by the pathology laboratory with an immunohistochemistry (IHC) score of HER2 0\u002F1+ or 2+ and negative in in situ hybridization (ISH), and estrogen receptor positive (ER+) breast cancer with or without progesterone receptor (PgR) expression;\n  3. Tumor histological grade 3, or histological grade 2 with the percentage of ER expression level between 1-10%;\n  4. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM classification, the clinical stage should be T1c-T2cN1-2 or T3-4cN0-2, M0 stage;\n  5. At least one measurable lesion (in accordance with the RECIST 1.1 version standard);\n  6. Expected survival time ≥ 12 weeks;\n  7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n  8. The subject has no severe blood, heart, lung, liver, or kidney function abnormalities and immunodeficiency diseases. The functional level of important organs within one week before the first administration must meet the following requirements:\n\n     1. Blood routine: HGB ≥ 90g\u002FL; WBC ≥ 4.0×109\u002FL; NEUT ≥ 2.0×109\u002FL; PLT ≥ 100×109\u002FL;\n     2. Blood biochemistry: TBIL ≤ 1.5×ULN; ALT and AST ≤ 3×ULN (for those with liver metastasis, ALT and AST ≤ 5×ULN); BUN and Cr ≤ 1.5×ULN and creatinine clearance rate ≥ 50 mL\u002Fmin;\n     3. Cardiac color Doppler ultrasound before the first administration must meet: left ventricular ejection fraction (LVEF) \\> 50%;\n  9. Thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be examined; if T3 and T4 levels are normal, the subject can be included;\n  10. Pregnant patients should have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures during the test period;\n  11. The subject voluntarily joins this study, signs the informed consent, has good compliance and is willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* If the patient meets any of the following conditions, they will not be eligible:\n\n  1. Patients with stage IV metastatic breast cancer or other conditions deemed by the researchers as not achievable through neoadjuvant therapy for radical surgical resection;\n  2. Bilateral invasive breast cancer;\n  3. Breast cancer patients who have previously received anti-tumor treatments such as chemotherapy, endocrine therapy, or undergone breast surgery (except for the diagnostic biopsy of primary breast cancer);\n  4. Patients who participated in other drug clinical trials within 4 weeks prior to enrollment, received major surgical treatment, incisional biopsy, or significant traumatic injury (except for the diagnostic biopsy of primary breast cancer);\n  5. Within 4 weeks before the first administration or planned to receive attenuated live vaccines during the study;\n  6. Patients with other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or papillary thyroid carcinoma;\n  7. Patients receiving any other anti-tumor treatment simultaneously;\n  8. Patients with a known history of allergy to the components of this study drug;\n  9. Patients with a clear history of neurological or mental disorders, including epilepsy or dementia, or a history of substance abuse or drug use for mental disorders;\n  10. Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n  11. Pregnant or lactating female patients, or female patients with reproductive capacity and positive baseline pregnancy test results;\n  12. Patients with active infectious diseases;\n  13. Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy;\n  14. Patients with active or potentially recurrent autoimmune diseases, except for: vitiligo, alopecia, psoriasis or eczema that do not require systemic treatment; hypothyroidism caused by autoimmune thyroiditis, requiring only a stable dose of hormone replacement therapy; type 1 diabetes requiring only a stable dose of insulin replacement therapy;\n  15. According to the investigator's judgment, there are serious diseases that endanger the patient's safety or affect the patient's ability to complete the study (including but not limited to drug-controlled interstitial lung disease, severe pulmonary dysfunction\u002Fdisease, cerebrovascular accident, severe diabetes);\n  16. Excluded patients with any of the following cardiovascular diseases:\n\n      1. Within 6 months before the first administration, experienced myocardial infarction, unstable angina pectoris, pulmonary embolism, acute\u002F persistent myocardial ischemia, cerebrovascular accident, transient cerebral ischemic attack, or other clinically significant\u002F requiring drug treatment intervention thromboembolic or ischemic events;\n      2. Had NYHA III-IV grade congestive heart failure in the past and\u002For currently;\n      3. Had severe arrhythmias that require drug treatment in the past and\u002For currently;\n      4. Within 12-lead ECG before the first administration showed a mean QT interval (QTcF) \\> 470 ms.\n  17. The investigator determines that the patient is not suitable to participate in this study.",{"count":125,"type":19},[22],"This study is a prospective, multicenter, single-arm, exploratory study. 30 patients with locally advanced HR+\u002FHER2- breast cancer who have not received any treatment were recruited to receive apalutamide voraparib combined with chemotherapy for neoadjuvant therapy. This study adopts Simon's two-stage design: in the first stage, 12 patients need to be enrolled. If among these 12 patients, 1 or fewer patients achieve tpCR, the study will be prematurely terminated due to early failure. Otherwise, 18 patients will be enrolled in the second stage. If 7 or more patients achieve tpCR among the 30 patients, the study achieves the expected results, and the drug can be further studied; otherwise, the study fails, and the drug does not need further study. The aim of this study is to evaluate the efficacy and safety of apalutamide voraparib combined with chemotherapy for neoadjuvant therapy in patients with HR+\u002FHER2- breast cancer.",[80],"2025-09-25",{"date":222,"type":30},"2025-09-29",{"date":224,"type":19},"2025-10-10",{"date":208,"type":19},{"name":36,"class":37},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":20,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":38},"100580508","phase-2-tislelizumab-combined-with-chemotherapy-and-relayed-radiotherapy-in-first-line-treatment-of-es-sclc-100580508","NCT06838208","Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC","Efficacy and Safety of Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in the First-line Treatment of Extensive Small Cell Lung Cancer: a Prospective, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n1. Age≥18 years old, male or female, signed Informed Consent Form (ICF);\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n3. Histologically or cytologically confirmed ES-SCLC;\n4. No prior systemic treatment for ES-SCLC;\n5. At least one measurable (RECIST 1.1) chest lesion capable of 15Gy\u002F5f irradiation;\n6. Adequate hematologic and end organ function;\n\nExclusion Criteria:\n\n1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis;\n2. Prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-PD-1), anti-PD-L1, or anti cytotoxic T lymphocyte associated antigen 4 (anti CTLA-4) antibody;\n3. Was administered a live vaccine ≤ 4 weeks before treatment;\n4. Active autoimmune diseases or history of autoimmune diseases that may relapse;\n5. Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before treatment;\n6. With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases;\n7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to treatment, including but not limited to tuberculosis infection;\n8. Received therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to starting treatment;",{"count":235,"type":19},56,[22],"To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer",[239],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","2025-09-18",{"date":242,"type":30},"2025-09-24",{"date":244,"type":30},"2025-02-25",{"date":246,"type":19},"2028-04-01",{"name":36,"class":37},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":74,"minAge":16,"maxAge":47,"enrollmentInfo":255,"targetDuration":4,"studyType":20,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":38},"100596590","phase-2-shr-1811-combined-with-carboplatin-in-the-treatment-of-advanced-breast-cancer-with-her2-expression-100596590","NCT07047443","SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression","Dose Exploration Study of SHR-1811 Combined With Carboplatin in the Treatment of Advanced Breast Cancer With HER2 Expression","Inclusion Criteria:\n\n1. Women aged 18 to 75 (inclusive of both values).\n2. Unresectable or metastatic breast cancer with HER2 positive (IHC 3+ or IHC 2+\u002FISH+), low HER2 expression (IHC 1+ or IHC 2+\u002FISH-), or ultra-low HER2 expression (IHC 0 with membrane staining) confirmed by histology or cytology.\n3. Failure of standard treatment in the advanced stage.\n4. For HER2+ metastatic breast cancer, one can have received second-generation ADC (such as T-DM1) treatment, but cannot have received third-generation ADC (such as T-DXd) treatment. For HER2 low expression or HER2 ultra-low expression metastatic breast cancer, it is necessary to meet the requirement that no ADC drug treatment has been received.\n5. For HER2-positive metastatic breast cancer, at the metastatic stage, ≥1 line of anti-HER2 treatment must have been received; For HR-positive metastatic breast cancer with low or ultra-low expression of HER2, it is necessary to meet the failure of CDK4\u002F6 inhibitor treatment at the metastatic stage. For HR-negative metastatic breast cancer with low or ultra-low expression of HER2, it is necessary to have received ≥ first-line chemotherapy at the metastatic stage.\n6. The ECOG score is 0 or 1.\n7. There is at least one lesion (including measurable or unmeasurable) according to the RECIST v1.1 standard.\n8. Adequate organ function.\n9. Participants with fertility or their spouses must agree to use appropriate contraceptive measures from the start of the first dose of the study treatment until 120 days after the last dose of the study treatment.\n10. Voluntarily join this study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Have had other malignant tumors within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n2. There is effusion in the third space that cannot be controlled by methods such as drainage (such as a large amount of ascites, pleural effusion, and pericardial effusion).\n3. Clinical researchers who have received surgical treatment (referring to major surgeries for cancer), radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drugs within 4 weeks before the first medication; Those who have received endocrine therapy within two weeks before the first medication.\n4. Patients with HER2+ metastatic breast cancer have received treatment with third-generation ADCs (such as T-DXd); Patients with HER2 low-expression or ultra-low-expression metastatic breast cancer who have received any ADC drug treatment.\n5. The patient has any active autoimmune diseases or a history of autoimmune diseases that may recur \\[including but not limited to: autoimmune hepatitis, uveitis, enteritis, pituitinitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects that can be controlled only through hormone replacement therapy can be included)\\]; Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes treated with insulin, or asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included. Asthma patients who require medical intervention with bronchodilators cannot be included.\n6. Have a history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n7. There are clinically significant cardiovascular diseases, such as severe\u002Funstable angina pectoris, symptomatic congestive heart failure (NYHA ≥ grade II), clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention, and myocardial infarction that occurred within 6 months before the first medication.\n8. Subjects with known or suspected interstitial pneumonia; There are other moderate to severe pulmonary diseases that may interfere with drug-related pulmonary toxicity testing or management and seriously affect respiratory function within three months before the first administration, including but not limited to idiopathic pulmonary fibrosis, organized pneumonia\u002Foblusive bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive\u002Frestrictive lung disease, etc. And any autoimmune, connective tissue or inflammatory diseases involving the lungs, such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc., or those who have undergone total lung resection surgery in the past. Subjects who had experienced grade ≥3 interstitial pneumonia during previous treatment with immune checkpoint inhibitors were not allowed to be enrolled in this study.\n9. Known hereditary or acquired bleeding predisposition (such as hemophilia, coagulation dysfunction, etc.).\n10. There are active hepatitis B (HBsAg positive and HBV DNA≥500 IU\u002FmL), hepatitis C (hepatitis C antibody positive and HCV RNA higher than the upper limit of the normal range), and liver cirrhosis; Or severely infected individuals who need to be controlled with antibiotics, antiviral drugs or antifungal drugs.\n11. According to the NCI-CTCAE v5.0 classification, those whose toxicity caused by previous anti-tumor treatment has not yet recovered to grade ≤ Ⅰ (except for alopecia; According to the judgment of the researchers, after consultation with the sponsor, some tolerable chronic grade II toxicities may be excluded.\n12. Known allergy to any of the investigational drugs or any of its excipients.",{"count":5,"type":19},[22],"To find the optimal dose of carboplatin combined with SHR-A1811 in her2-expressed metastatic breast cancer",[80],"2025-06-23",{"date":261,"type":30},"2025-07-02",{"date":263,"type":19},"2025-08-01",{"date":265,"type":19},"2029-12-31",{"name":36,"class":37},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":20,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":4},"100590892","phase-2-sintilimab-plus-apatinib-and-sox-as-first-line-treatment-in-patients-with-afp-gastric-or-gastroesophageal-junction-adenocarcinoma-100590892","NCT06973330","Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma","Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma: a Single-arm, Multi-center, Phase II Trial","Inclusion Criteria:\n\n1. Male or female patients ≥18 years old;\n2. Patients with advanced \u002F metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, serum AFP ≥ 2xULN or AFP positive by the IHC staining;\n3. No previous palliative systemic treatment;\n4. There are measurable metastatic lesions according to RECIST version 1.1;\n5. ECOG physical status score is 0 or 1；\n6. Normal organ function: Neutrophil count ≥ 1.2 × 109\u002FL, Platelet count ≥ 100 × 109\u002FL, Hemoglobin (HB) ≥ 80g\u002FL, Total bilirubin ≤ 1.5mg\u002Fdl, AST and ALT ≤ 100 IU\u002FL. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU\u002FL, Creatinine ≤ 1.5 times\\* upper limit of normal, International standardization ratio (INR) ≤ 1.5;\n7. Urinary protein: meet one of the following conditions Urinary protein (test paper method) is 2 + or less, Urinary protein\u002Fcreatinine (UPC) ratio \\\u003C 3.5, Determination of 24-hour urinary protein, urinary protein ≤ 3500mg;\n8. Before receiving treatment, the patient has recovered the adverse events related to chemotherapy, radiotherapy and surgery to grade 1 or below (CTCAE 5.0);\n9. For women with fertility potential with negative pregnancy test within 14 days before enrollment, male and female patients should agree to use appropriate contraceptive methods from the beginning of the first treatment to 120 days after the last treatment;\n10. Patients who can take oral drugs;\n11. Signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients who received surgery and radiotherapy within 2 weeks before enrollment;\n2. Patients who have previously been treated with Apatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs;\n3. Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg);\n4. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment;\n5. Patients with symptomatic brain metastases;\n6. Patients with New York Heart Association (NYHA) grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in the past 6 months;\n7. The patients had active malignancies in the past 24 months (except for melanoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma or carcinoma in situ of the cervix) ;\n8. The patients have severe (hospitalized) complications;\n9. Patients with a history of gastrointestinal perforation and\u002For gastrointestinal fistula within 6 months before enrollment;\n10. Patients with active hepatitis;\n11. Patients with a history of human immunodeficiency virus (HIV) infection; 12. Patients with symptoms or signs of active interstitial pulmonary disease; 13. Patients with autoimmune diseases or a history of chronic or recurrent autoimmune diseases;\n\n14\\. Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment; 15. The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia; 16. Patients who received live vaccine \\\u003C 30 days before starting trial drug treatment; The patient has serious non-healing wounds, ulcers or fractures; 17. Pregnant or lactating women; 18. The investigator determined that the patient is not suitable to be the subject of this trial; 19. Other circumstances that the investigator considers inappropriate to participate in the clinical trial.",{"count":275,"type":19},40,[22],"This is a multi-center, prospective, open label phase II study evaluating the safety and efficacy of standard first-line chemotherapy SOX regimen combined with Sintilimab (anti-PD-1 antibody) and Apatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Anhui Provincial Cancer Hospital. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with SOX regimen combined with Sintilimab plus Apatinib every 3 weeks(4 cycles) followed by sintilimab+apatinib until disease progression or intolerable adverse reactions or death(up to 24 months).Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.",[279],"AFP Gastric or Gastroesophageal Junction Adenocarcinoma","2025-06-12",{"date":282,"type":30},"2025-06-15",{"date":284,"type":19},"2025-07",{"date":286,"type":19},"2027-05-01",{"name":36,"class":37},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":149,"enrollmentInfo":295,"targetDuration":4,"studyType":20,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100594036","phase-2-pd-1-combined-with-bevacizumab-and-pcsk-9-inhibitor-in-patients-with-advanced-nsclc-who-have-progressed-after-anti--pd--1l1-therapy-100594036","NCT07014215","PD-1 Combined With Bevacizumab and PCSK-9 Inhibitor in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1\u002FL1 Therapy","A Phase II Study Evaluating the Safety and Efficacy of Sintilimab Plus Bevacizumab and Tafolecimab in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1\u002FL1 Therapy","Inclusion Criteria:\n\n* 1\\. Sign written informed consent before implementing any experimental procedures\n* 2\\. Age ≥ 18 years old and ≤ 80 years old\n* 3\\. Histological or cytological confirmation of locally advanced (IIIB-IIIC), metastatic or recurrent (stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint Committee on Cancer Classification 9th edition TNM lung cancer staging)\n* 4\\. Failure after previous treatment with PD - (L) 1 inhibitors (alone or in combination with another systemic therapy) (CR, PR, SD\\>6 months)\n* 5\\. Previously not receiving anti angiogenic drug treatment\n* 6\\. Confirmed by histological specimens that there are no EGFR gene sensitive mutations, ALK gene fusion mutations, ROS1 gene mutations, or RET gene mutations\n* 7\\. According to the criteria for evaluating the efficacy of solid tumors (RECIST v1.1 version), there should be at least one measurable lesion on imaging. If the lesion located within the previous radiation field is confirmed to have progressed, it can be considered a measurable lesion\n* 8\\. Subjects with brain metastases who are asymptomatic or have stable symptoms after local treatment are allowed to be enrolled, as long as they meet the following conditions:\n\n  1. Measurable lesions outside the central nervous system\n  2. No central nervous system symptoms or no worsening of symptoms within at least 2 weeks\n  3. No need for glucocorticoid treatment, or discontinuation of glucocorticoid treatment within 7 days prior to the first dose, or stable and reduced glucocorticoid dosage to below 10mg\u002Fday of prednisone (or equivalent dose) within 7 days prior to the first dose\n* 9\\. Subjects are allowed to receive palliative radiation therapy (including cranial radiation therapy for symptomatic brain metastases), provided that the radiation therapy is completed at least one week before enrollment and the radiation related toxicity has recovered to less than or equal to degree 1 (CTCAE 5.0, except for hair loss)\n* 10\\. ECOG rating 0-1 points\n* 11\\. Expected survival time\\>3 months\n* 12\\. Adequate organ function, subjects must meet the following laboratory indicators:\n\n  1. In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) is ≥ 1.5x10\\*9\u002FL\n  2. Platelets ≥ 100 × 10\\*9\u002FL without blood transfusion in the past 14 days\n  3. Hemoglobin\\>9g\u002FdL without blood transfusion or use of erythropoietin in the past 14 days\n  4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  5. Aspartate transaminase (AST) and alanine transaminase (ALT) levels should be ≤ 2.5 × ULN (subjects with liver metastases are allowed to have ALT or AST levels ≤ 5 × ULN)\n  6. Blood creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Gault formula) ≥ 60 ml\u002Fmin\n  7. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN\n  8. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled\n  9. The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included)\n* 13\\. For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy\n* 14\\. If there is a risk of conception, all subjects (regardless of gender) must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days (or 180 days) after the last administration of the study drug\n\nExclusion Criteria:\n\n* 1\\. Pathological diagnosis of small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC\n* 2\\. The patient has received first-line or more PD - (L) 1 inhibitor monotherapy or combination chemotherapy treatment\n* 3\\. Received the following treatments:\n\n  1. Received systemic anti-tumor therapy within 3 weeks prior to treatment, such as chemotherapy, targeted therapy, immunotherapy (including herbal therapy with anti-tumor indications), etc\n  2. Received any investigational drug treatment within 4 weeks prior to treatment\n  3. Received high doses of immunosuppressive drugs (systemic corticosteroids exceeding 10mg\u002Fday, prednisone or its equivalent) within 4 weeks prior to treatment\n  4. Received attenuated live vaccine within 4 weeks prior to treatment (or planned to receive attenuated live vaccine during the study period)\n  5. Has undergone major surgery (such as open cavity, thoracotomy, or Kaifu surgery) within 4 weeks before treatment, or has unhealed surgical wounds, ulcers, or fractures\n* 4\\. There is clinically uncontrollable pleural\u002Fperitoneal effusion (subjects who do not require drainage or have no significant increase in effusion after stopping drainage for 3 days can be enrolled)\n* 5\\. Subjects who have received chest radiation therapy greater than 30 Gy within the 6 months prior to treatment or palliative radiation therapy with a dose of 30 Gy or less within the 7 days prior to treatment (palliative radiation therapy for bone lesions or intracranial lesions is allowed)\n* 6\\. Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments\n* 7\\. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation\n* 8\\. Individuals known to be allergic to the active ingredients or excipients of the study drug\n* 9\\. Before starting treatment, if there has been no sufficient recovery from toxicity and\u002For complications caused by any intervention measures (i.e. ≤ grade 1 or baseline, excluding fatigue or hair loss)\n* 10\\. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive)\n* 11\\. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center) Note: Those who meet the following criteria can also be included in the group:\n\n  1. Before the first administration, the HBV viral load was less than 1000 copies\u002Fml (200 IU\u002Fml), and subjects should receive anti HBV treatment throughout the entire study drug treatment period to avoid viral reactivation\n  2. For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary\n* 12\\. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit)\n* 13\\. Administer a live vaccine within 30 days prior to the first dose (Day 1 of the first cycle) Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration; But it is not allowed to receive attenuated live influenza vaccine for intranasal use\n* 14\\. Pregnant or lactating women\n* 15\\. There are any serious or uncontrollable systemic diseases, such as:\n\n  1. Resting electrocardiogram shows significant and difficult to control abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, grade II or higher heart block, ventricular arrhythmia, or atrial fibrillation\n  2. Unstable angina pectoris, congestive heart failure, chronic heart failure classified as NYHA ≥ 2\n  3. Myocardial infarction occurred within 6 months prior to enrollment\n  4. Poor blood pressure control (systolic blood pressure\\>140 mmHg, diastolic blood pressure\\>90 mmHg)\n  5. A history of non infectious pneumonia requiring corticosteroid treatment within the year prior to the first administration, or current clinical active interstitial lung disease\n  6. Active pulmonary tuberculosis\n  7. There are active or uncontrolled infections that require systemic treatment\n  8. Presence of clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction\n  9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis\n  10. Poor control of diabetes (FBG\\>10mmol\u002FL)\n  11. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\\>1.0 g\n  12. Subjects with mental disorders who are unable to cooperate with treatment\n* 16\\. Medical history or disease evidence that may interfere with the trial results, hinder the full participation of the subjects in the study, abnormal treatment or laboratory test values, or other situations that the researchers believe are not suitable for inclusion. The researchers believe that there are other potential risks that are not suitable for participation in this study",{"count":296,"type":19},52,[22],"This study evaluated the sintilimab combination of bevacizumab and tafolecimab in NSCLC patients who have previously been treated with anti- PD- 1\u002Fligand (L)1 and acquired resistance. The patients were assigned to receive sintilimab(200mg Q3W) in combination with bevacizumab(7.5mg\u002Fkg Q3W) and tafolecimab(600 mg Q6W). The primary endpoints of the study were progression- free survival (PFS) assessed by RECISTv1.1 , while secondary endpoints included objective response rate (ORR), and overall survival (OS) and safety.",[53,300],"Resistance to Immunotherapy","2025-06-09",{"date":303,"type":30},"2025-06-10",{"date":305,"type":19},"2025-06",{"date":307,"type":19},"2029-05",{"name":36,"class":37},{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":20,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":38},"100590893","phase-2-sintilimab-plus-bevacizumab-and-chemotherapy-in-msspmmr-colorectal-with-no-liver-metastasis-100590893","NCT06973343","Sintilimab Plus Bevacizumab and Chemotherapy in MSS\u002FpMMR Colorectal With no Liver Metastasis","Sintilimab Plus Bevacizumab and Chemotherapy on Treatment in Patients With Advanced no Liver Metastatic MSS\u002FpMMR Colorectal Cancer: Phase II Cohort Study","Inclusion Criteria:\n\n1. Sign written informed consent before implementing any experimental procedures\n2. Over 18 years old\n3. Histologically confirmed as colorectal adenocarcinoma without liver metastasis\n4. At least one measurable lesion (RECIST 1.1)\n5. Satellite stable (MSS) or low instability (MSI-L) or normal expression of DNA mismatch repair genes (pMMR)\n6. ECOG PS score is 0-1\n7. Progress after initial treatment or standard first-line treatment\n8. Have sufficient organ and bone marrow function\n9. Expected to survive for more than 3 months\n10. Participants must have normal hematological test results, including：\n\n    * absolute neutrophil count (ANC) greater than 1.5 × 109\u002FL\n    * hemoglobin greater than 8 g\u002FdL\n    * platelet count greater than 80-100 × 109\u002FL\n11. Participants' prothrombin time (PT) must be less than 1.5 times the upper limit of normal values, and activated partial thromboplastin time (APTT) must be less than 1.5% of the upper limit of abnormal values\n12. Participants must have normal laboratory test results, including：serum creatinine levels less than or equal to 1.5 times the upper limit of the normal reference range, or creatinine clearance rates greater than 50 ml\u002Fmin\n13. For participants without liver metastasis, their alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels must be less than or equal to 2.5 times the upper limit of the normal reference range, and their serum total bilirubin levels must be less than 1.5 times the upper limit of the normal reference range\n14. For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle)\n15. If there is a risk of conception, all subjects must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug\n16. The subjects must agree to provide sufficient tumor tissue samples for PD-L1 expression detection\n\nExclusion Criteria:\n\n1. Known presence of active central nervous system (CNS) metastases and\u002For cancerous meningitis\n2. Microsatellite instability (MSI-H) or loss of expression of DNA mismatch repair genes (dMMR)\n3. Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration\n4. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors\n5. Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment\n6. Imaging shows tumor invasion\u002Finfiltration into large blood vessels, or researchers or radiologists assess a tendency towards bleeding\n7. Have undergone major surgical treatment within 4 weeks prior to the initial administration of the investigational drug (excluding surgery for biopsy purposes) or are expected to undergo major surgery during the study period\n8. Severe unhealed wounds, ulcers, or fractures\n9. Undertook minor surgeries within 48 hours prior to the first receipt of the study drug\n10. Currently or recently (within 10 days prior to receiving the first dose of the study drug) using aspirin (\\>325 mg\u002Fday) or other known nonsteroidal anti-inflammatory drugs that can inhibit platelet function for 10 consecutive days\n11. Currently or recently (within 10 days prior to receiving the first dose of the study drug), using full dose oral or parenteral anticoagulants or thrombolytic agents for treatment for 10 consecutive days\n12. There is a genetic tendency for bleeding or coagulation dysfunction, or a history of thrombosis\n13. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation\n14. Individuals known to be allergic to the active ingredients of the study drug\n15. Prior to commencing treatment, the individual has not fully recovered from any toxicity and\u002For complications caused by any intervention measures (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss)\n16. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive)\n17. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center)\n18. Pregnant or lactating women\n19. The presence of any serious or uncontrollable systemic disease\n\n21\\. Other situations that the researchers believe are not suitable for inclusion, or other potential risks that are not suitable for participation in this study",{"count":317,"type":19},20,[22],"This is a non-randomized, open-label, single-center clinical trial to evaluate efficacy and safety of sintilimab plus bevacizumab and chemotherapy on treatment in patients with advanced no liver metastatic MSS\u002FpMMR colorectal cancer",[321],"Colorectal Cancer Metastatic","2025-05-14",{"date":324,"type":30},"2025-05-15",{"date":326,"type":19},"2025-05",{"date":328,"type":19},"2027-12",{"name":36,"class":37},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":20,"phases":339,"briefSummary":340,"conditions":341,"keywords":345,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":38},"100571012","phase-2-low-dose-radiotherapy-combined-with-sintilimab-and-chemotherapy-as-neoadjuvant-therapy-for-stage-ii-iii-nsclc-100571012","NCT06714708","Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC","SPARK: Safety and Efficacy of Low Dose Radiotherapy Combined With Sintilimab and Platinum Based Chemotherapy as Neoadjuvant Therapy for Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients who meet all of the following inclusion criteria are eligible for inclusion in this study:\n\n  1. Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.\n  2. Age ≥ 18 years old.\n  3. Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.\n  4. According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM staging classification of lung cancer, the clinical staging is IIB (primary tumor\\>4cm), IIIA, or IIIB (resectable N2 only) stage. Resectable N2 refers to non bulk (defined as a short diameter less than 3cm), discrete, or single site N2 involvement. If clinically suspected as N2 or N3, pathological confirmation is required.\n  5. Non squamous NSCLC subjects need to undergo genetic testing to confirm the absence of EGFR sensitive mutations and ALK rearrangements. Squamous NSCLC subjects are not required to undergo genetic testing, but subjects with known EGFR sensitive mutations and ALK rearrangements should not be included in the study.\n  6. Considered suitable for radical resection surgery.\n  7. The lung function meets the criteria for planned lung resection (FEV1 ≥ 50% predicted value, MVV ≥ 50% predicted value), and there are no surgical contraindications.\n  8. Can provide sufficient tissue specimens that meet the requirements for PD-L1 testing during the screening period.\n\nAccording to RECIST V1.1, there is at least one measurable lesion. 10. The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1.\n\n11\\. Have not received any systemic anti-tumor therapy or local radiotherapy for NSCLC in the past.\n\n12\\. Possess sufficient organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to enrollment (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous drugs for correcting hematological or liver and kidney dysfunction are allowed within 14 days prior to obtaining laboratory tests), as follows: Hematological function is sufficient, defined as absolute neutrophil count ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 100g\u002FL;\n\n* Adequate liver function, defined as total bilirubin levels ≤ 1.5 × upper limit of normal (ULN) and levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, albumin (ALB) ≥ 35g\u002FL;\n* Adequate renal function, serum creatinine (Scr) ≤ 1.5 × ULN, creatinine clearance rate (CrCl) ≥ 60mL\u002Fmin (calculated using the Cockcroft\u002FGault formula), and urine routine test results showing urinary protein (UPRO)\\\u003C2+or 24-hour urine protein dose\\\u003C1g; Within 7 days prior to treatment, the international normalized ratio (INR) is ≤ 1.5 × ULN, and the prothrombin time (PT) or activated partial thromboplastin time (APTT) is ≤ 1.5 × ULN.\n\n  13\\. For female subjects of childbearing age, urine or serum pregnancy tests were negative within 7 days prior to receiving the first study drug administration. 14.If the urine pregnancy test result is positive, a blood pregnancy test is required.\n\n  15.If there is a risk of conception, male and female patients should use highly effective contraception (i.e. methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable as a contraceptive method.\n\nExclusion Criteria:\n\n* 1\\. Histological and pathological examinations show the presence of coexisting small cell carcinoma, large cell neuroendocrine tumor, and sarcomatoid tumor components.\n\n  2\\. Tumors invade the diaphragm, mediastinum, heart, pericardium, large blood vessels (such as aorta), trachea, recurrent laryngeal nerve, esophagus, vertebral body, and protuberance.\n\n  3\\. Tumor of the superior sulcus of the lung. 4. There are tumor nodules in the contralateral lung lobe; If there is clinical suspicion of tumor nodules in the contralateral lung lobe, biopsy is required for clarification.\n\n  5\\. Confirm or suspect patients with brain metastases. 6. Currently participating in interventional clinical research treatment, or having received other investigational drugs or devices within the first 4 weeks of randomization.\n\n  7\\. Previous use of anti-PD-1, anti-PD-L1, anti programmed death receptor ligand 2 (PD-L2), or anti cytotoxic T lymphocyte associated antigen 4 (CTLA-4) drugs or any other drugs that act on T cell co stimulatory or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cell immunotherapy.\n\n  8\\. Have received Chinese herbal medicine, traditional Chinese patent medicines and simple preparations with anti-tumor indications, or drugs with immunomodulatory effects (including thymic peptides, interferon, interleukin) within the first two weeks of randomization.\n\n  9\\. Have undergone major surgery within the first 4 weeks of randomization. 10. There are unhealed surgical incisions, ulcers, or fractures present. 11. Received attenuated live vaccine within the first 4 weeks of randomization (or planned to receive attenuated live vaccine during the study period). Note: Accepting inactivated virus vaccines for injection against seasonal influenza is allowed; However, receiving attenuated live influenza vaccines is not allowed.\n\n  12\\. Patients who require long-term systemic use of corticosteroids; Received any other form of immunosuppressive therapy within the first 7 days of randomization. Note: Local corticosteroids administered via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses (≤ 10mg\u002Fday of prednisone or equivalent), or for pre-treatment purposes (such as preventing contrast agent allergies), are allowed.\n\n  13\\. There is a history of non infectious pneumonia requiring glucocorticoid treatment or current interstitial lung disease within the previous year of randomization.\n\n  14\\. Within the first 2 years of randomization, there have been active autoimmune diseases that require systemic treatment (such as the use of disease improving drugs, corticosteroids, or immunosuppressants), including but not limited to inflammatory bowel disease, such as ulcerative colitis or Crohn's disease; Diverticulitis; Celiac disease; Systemic lupus erythematosus; Sarcoidosis syndrome or Wegener syndrome (granulomas with polyangitis); Graves' disease; Rheumatoid arthritis; Multiple sclerosis; Vasculitis; Glomerulonephritis; Antiphospholipid syndrome; Pituitary inflammation; Uveitis, etc. Alternative therapies such as thyroid hormone, insulin, or physiological dose corticosteroids used for adrenal or pituitary insufficiency are not considered systemic treatments. Patients with positive autoimmune antibodies need to be evaluated and confirmed by the researcher that there are no autoimmune diseases that require systemic treatment before they can be enrolled.\n\n  15\\. Suffering from primary immunodeficiency disease. 16. Past or current presence of myocarditis. 17. Prior to randomization, there was insufficient recovery from toxicity and\u002For complications caused by any intervention measures (i.e.,\\>grade 1 or not recovered to baseline levels).\n\n  18\\. ≥ Grade 2 peripheral neuropathy. 19. Genetic bleeding tendency or coagulation dysfunction, or history of thrombosis: Any arterial thrombosis, embolism, or ischemia occurred within the first 6 months of randomization, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism. A history of deep vein thrombosis or any other severe thromboembolism within the first 3 months of randomization (implantable venous infusion port or catheter-related thrombosis, or superficial vein thrombosis is not considered a \"severe\" thromboembolism).\n\n  20\\. Uncontrolled hypertension (systolic blood pressure greater than 160mmHg and\u002For diastolic blood pressure greater than 100mmHg); History of hypertensive crisis or hypertensive encephalopathy; Uncontrolled hyperglycemia (fasting blood glucose\\>8.9 mmol\u002FL).\n\n  21\\. Any unstable systemic disease or concurrent disease, including but not limited to:\n  * Active infection (requiring treatment with anti infective drugs or having used systemic anti infective drugs within the week prior to randomization);\n  * Congestive heart failure \\[New York Heart Association (NYHA) classification ≥ II\\]; Serious arrhythmias, liver, kidney or metabolic diseases that require medication treatment;\n  * Untreated coronary atherosclerotic heart disease; Type I or II respiratory failure; History of gastrointestinal perforation and\u002For fistula, intestinal obstruction, extensive intestinal resection, or long-term chronic diarrhea within the past 6 months.\n\n    22\\. Received solid organ or blood system transplantation. 23. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV1\u002F2 antibody positive), known active syphilis.\n\n    24\\. Active or tuberculosis requiring medical intervention at this stage, including but not limited to tuberculosis.\n\n    25\\. Active hepatitis B.\n  * Subjects with hepatitis B who meet the following criteria meet the inclusion criteria: HBsAg (+) or HBcAb (+), HBV viral load before randomization\\\u003C1000 copies\u002Fml or\\\u003C200IU\u002Fml or lower than the detection limit.\n\nHBsAg (+) subjects should receive anti HBV therapy throughout the entire study drug treatment period to avoid viral activation.\n\nFor subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of virus reactivation is necessary.\n\n26\\. Active hepatitis C (HCV antibody positive and HCV-RNA level above the detection limit).\n\n27\\. Malignant tumors other than diagnosed NSCLC within the first 5 years of randomization, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and papillary thyroid carcinoma after radical surgery.\n\n28\\. It is known that there is an allergic reaction to the active ingredients and\u002For any excipients of the selected chemotherapy regimen (non squamous NSCLC: pemetrexed plus cisplatin or carboplatin; squamous NSCLC: gemcitabine, docetaxel, paclitaxel or albumin paclitaxel plus cisplatin or carboplatin).\n\n29\\. Pregnant or lactating women or women preparing to become pregnant or breastfeed during the study period.\n\n30\\. It is known that there are mental illnesses or drug abuse situations that may affect compliance with experimental requirements, and there is a history of alcohol abuse.\n\n31\\. There may be medical history, diseases, treatments, or laboratory abnormalities that could interfere with the trial results, hinder the full participation of the subjects in the study, or the researcher believes that participating in the study is not in the best interests of the subjects. Local or systemic diseases caused by non malignant tumors, or secondary reactions to cancer, can lead to higher medical risks and\u002For uncertainty in survival evaluation.",{"count":338,"type":19},86,[22],"To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer",[179,342,343,344],"Neoadjuvant Immunotherapy","Low Dose Radiotherapy","Sintilimab",[179,342,343,344],"2025-02-06",{"date":348,"type":30},"2025-02-10",{"date":350,"type":30},"2024-11-20",{"date":352,"type":19},"2027-06-01",{"name":36,"class":37},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":74,"minAge":16,"maxAge":47,"enrollmentInfo":361,"targetDuration":4,"studyType":20,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":38},"100549693","phase-2-surufatinib-combined-with-carboplatinpaclitaxel-and-surufatinib-combined-with-olaparib-as-first-line-and-maintenance-therapy-for-newly-diagnosed-high-risk-ovarian-cancer-100549693","NCT06437353","Surufatinib Combined With Carboplatin\u002FPaclitaxel and Surufatinib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer","Sorafenib Combined With Carboplatin\u002FPaclitaxel and Sorafenib Combined With Olaparib as First-line and Maintenance Therapy for Newly Diagnosed High-risk Ovarian Cancer: a Single-arm, Multicenter, Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age: 18-75 years old (≥18, ≤75)\n2. Patients with newly diagnosed FIGO stage III or IV high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal cancer, and\u002For fallopian tube cancer with high-risk factors for recurrence. High-risk recurrence is defined as follows:\n\n   * FIGO stage III with non-R0 resection;\n   * FIGO stage IV;\n   * Presence of ascites at initial diagnosis.\n3. Patients who have undergone primary debulking surgery (PDS) for ovarian cancer.\n4. ECOG performance status score: 0-2.\n5. Postoperative administration time ≤12 weeks.\n6. Expected survival of at least 3 months.\n7. Major organ function within 7 days prior to treatment meets the following criteria:\n\n   * Hemoglobin (HB) ≥90 g\u002FL;\n   * Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n   * Platelets (PLT) ≥100×10⁹\u002FL.\n8. Biochemical parameters must meet the following standards:\n\n   * Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, or ≤5×ULN if liver metastases are present;\n   * Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 ml\u002Fmin.\n9. Women of childbearing potential must use effective contraception.\n10. Subjects must voluntarily join the study and sign the informed consent form (ICF).\n11. Subjects are expected to have good compliance and the ability to follow up on efficacy and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n1. Previous treatment with anti-angiogenic drugs such as apatinib, sorafenib, anlotinib, bevacizumab, or other anti-angiogenic therapies.\n2. Pregnant or breastfeeding women.\n3. Patients who have previously participated in other clinical trials that have not yet concluded.\n4. Patients with evidence or history of significant bleeding tendencies or events within 3 months before enrollment (bleeding \\>30 mL, accompanied by hematemesis, melena, or hematochezia), hemoptysis (≥5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke and\u002For transient ischemic attack) within 12 months.\n5. Patients with uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).\n6. Patients with grade I or higher myocardial ischemia or infarction, arrhythmias (including QTc ≥480 ms), or ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification).\n7. Patients with active or uncontrolled severe infections (≥CTC AE grade 2).\n8. Patients with renal failure requiring hemodialysis or peritoneal dialysis.\n9. Patients with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or those with a history of organ transplantation.\n10. Patients with persistent proteinuria (≥++) on two consecutive urine tests, and confirmed 24-hour urine protein \\>1.0 g.\n11. Patients with psychiatric disorders, including epilepsy, dementia, severe depression, mania, etc.\n12. Patients with any signs or history of bleeding disorders, regardless of severity; patients who experienced any bleeding or hemorrhagic event ≥CTCAE grade 3 within 4 weeks before enrollment; patients with unhealed wounds, ulcers, or fractures.\n13. Patients who had arterial or venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within the past 6 months.\n14. Patients with symptomatic brain metastases or those whose symptoms have been controlled for less than 2 months.\n15. Patients with a history of substance abuse that cannot be relinquished or those with psychiatric disorders.\n16. Patients with difficulty swallowing or known absorption disorders affecting drug intake.\n17. Patients allergic to treatment drugs sorafenib or paclitaxel\u002Fcarboplatin.\n18. Any other condition that the researcher deems unsuitable for enrollment.",{"count":362,"type":19},74,[22],"The goal of this type of clinical trial study is to evaluate the safety and efficacy of Surufatinib combined with Carboplatin\u002FPaclitaxel and Surufatinib combined with Olaparib as first-line and maintenance therapy for newly diagnosed high-risk ovarian cancer",[366],"Ovarian Cancer",[368],"Antiangiogenic","2024-11-26",{"date":371,"type":30},"2024-11-27",{"date":373,"type":30},"2024-05-25",{"date":375,"type":19},"2027-10-30",{"name":36,"class":37},{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":74,"minAge":16,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":20,"phases":386,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":38},"100552066","phase-2-an-exploratory-clinical-study-of-statins-for-improving-chemotherapy-and-maintenance-in-patients-with-ovarian-cancer-100552066","NCT06468254","An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer","An Exploratory Clinical Study of Statins for Improving Chemotherapy and Maintenance in Patients With Ovarian Cancer: a Prospective, Multicenter Clinical Study","Inclusion Criteria:\n\n* Participants must provide written informed consent before any trial procedures commence. The consent form must be documented and retained at the research center.\n* Female patients aged 18 years and older.\n* Patients diagnosed with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (collectively referred to as ovarian cancer) through open surgery, laparoscopic surgery, or core needle biopsy confirmed by pathology.\n* Patients who will require neoadjuvant chemotherapy followed by direct surgery, or direct surgical chemotherapy.\n* Liver Function:\n\n  1. Total bilirubin ≤1.5 times the upper limit of normal (ULN) or direct bilirubin ≤1.0 times ULN;\n  2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN. In cases of liver metastases, AST and ALT must be ≤5 times ULN.\n* Kidney Function: Serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n* Participants must be able to understand the trial procedures and be capable of adhering to the trial protocol for the duration of the study. This includes the ability to complete any required treatments, examinations, tests, follow-up appointments, and questionnaires associated with the trial.\n\nExclusion Criteria:\n\n* Are using other investigational drugs or participating in other clinical drug trials simultaneously;\n* Have used or are currently using any medications that interact with statins;\n* Have active cirrhosis, uncontrolled concurrent diseases, a history of chronic myopathy, active hepatitis, or unexplained persistent elevation of serum aminotransferases;\n* Are known to be allergic to statins, or any active or inactive components of drugs with similar chemical structures;\n* Are unable to swallow oral medications or have any gastrointestinal disorders that might interfere with the absorption and metabolism of the study drugs, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;\n* Require treatment for symptomatic or uncontrolled brain metastases, including but not limited to surgery, radiation, and\u002For corticosteroids, or have clinical signs of spinal cord compression;\n* Have severe, uncontrolled diseases or conditions that, in the investigator's judgment, make the participant unsuitable for the study. These include but are not limited to:\n\n  1. Active viral infections such as HIV, hepatitis B, or hepatitis C.\n  2. Severe cardiovascular diseases, including uncontrolled ventricular arrhythmias or a recent (within the last 3 months) myocardial infarction.\n  3. Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorders affecting the ability to provide informed consent.\n  4. Uncontrolled hypertension not managed by medication. Immune deficiencies (excluding splenectomy) or other conditions deemed by the investigator to pose a high risk of toxicity.\n* Have any medical history or existing clinical evidence indicating the potential to confound study results, interfere with adherence to the trial protocol throughout the study, or not align with the patient's best interests;\n* Have a history of or current evidence of other malignancies;\n* Are pregnant, breastfeeding, or planning to become pregnant during the study period.",{"count":385,"type":19},500,[22],"This study aims to evaluate the effect of statins combined with conventional chemotherapy and maintenance therapy on the prognosis of ovarian cancer patients, exploring its potential to improve survival rates and quality of life.",[366],[390],"Statins","2024-06-15",{"date":393,"type":30},"2024-06-21",{"date":395,"type":19},"2024-06-30",{"date":397,"type":19},"2026-03-30",{"name":36,"class":37},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":74,"minAge":16,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":20,"phases":409,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":417,"leadSponsor":419,"locationsCount":38},"100546508","phase-1-safety-and-efficacy-of-intraperitoneal-injection-of-metr-nk-cells-as-neoadjuvant-therapy-for-advanced-epithelial-ovarian-cancer-100546508","NCT06395844","Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer","Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer: A Single-arm, Single-center, Exploratory Clinical Study","Inclusion Criteria:\n\n* Age: 18-70 years old (≥18, ≤70);\n* Open surgery, laparoscopic surgery, or coarse needle biopsy for histopathological confirmation of advanced (FIGO IIIC\u002FIV stage) high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal carcinoma, and\u002For fallopian tube carcinoma, etc.;\n* ECOG score: 0-1;\n* Blood and tissue specimens before, during, and after treatment can be obtained, and subjects agree to submit blood and tissue specimens to the central laboratory for the purpose of expanding research in this trial;\n* At least one lesion measurable by CT\u002FMRI according to RECIST 1.1 criteria;\n* Expected survival of at least 3 months;\n* Patients judged by professional gynecologic oncologists as unable to achieve R0 resection or intolerant to surgery.\n\n  * Criteria for determining inability to achieve R0 resection include but are not limited to: Fagotti laparoscopic score ≥8 points; When laparoscopic evaluation is difficult to implement, an upper abdominal CT score ≥3 points may be used;\n  * Criteria for intolerance to surgery may include: Advanced age: age ≥70; Body mass index: BMI ≥40.0; Multiple chronic diseases; Malnutrition or hypoalbuminemia; Moderate to large amount of ascites; Newly diagnosed venous thromboembolism (survival period greater than 12 weeks);\n* Major organ function meets the following criteria within 7 days before treatment: Hematological examination: Hemoglobin ≥90g\u002FL, white blood cell count ≥3×10\\^9\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥90×10\\^9\u002FL; Kidney: Serum creatinine \\\u003C1.5 mg\u002FdL, glomerular filtration rate (GFR) ≥50 ml\u002Fmin (based on the Fairview Laboratories formula at screening); Liver: AST, ALT, and alkaline phosphatase \\\u003C3 times the upper limit of normal for the institution, total bilirubin \\\u003C1.5 times the upper limit of normal for the institution; Lung function: Resting oxygen saturation ≥90%; Cardiac function: Left ventricular ejection fraction (LVEF) ≥40% by echocardiography, MUGA, or cardiac MRI; no evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, or acute ischemia or active conduction system abnormalities on electrocardiography;\n* No history of intestinal obstruction within two months;\n* Reproductive-age patients must take effective contraceptive measures;\n* Subjects voluntarily join this study and sign an informed consent form (ICF);\n* Good compliance is expected, and subjects are able to follow up on efficacy and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* Patients who have received drugs or other cell immunotherapy in other clinical trials within 28 days before the screening period;\n* Patients who have had other malignant tumors in the past 5 years;\n* Acute illnesses are ongoing, or severe illnesses have occurred in the past 2 years, such as patients with active infections or fever, cardiovascular diseases (Grade III or IV heart failure), mental health issues (such as alcoholism, drug abuse);\n* History of immunodeficiency, including HIV-positive status or other acquired, congenital immunodeficiency diseases;\n* Organ transplant or organ failure patients, patients receiving immunosuppressive therapy after organ transplantation, or patients taking immunosuppressive drugs long-term;\n* Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism within 6 months;\n* Known allergy to any component of the final product of METR-NK preparation, including human serum albumin;\n* Breastfeeding during the screening period or female subjects with positive serum or urine pregnancy tests;\n* Patients with mental illnesses, including epilepsy, dementia, severe depression, bipolar disorder, etc.;\n* Other conditions deemed unsuitable for inclusion by the investigator.","70 Years",{"count":408,"type":19},28,[410,22],"PHASE1","The goal of this type of clinical trial study is to evaluate the safety and efficacy of metabolic remodeling nature killer cells as neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer",[366],"2024-05-01",{"date":415,"type":30},"2024-05-02",{"date":413,"type":19},{"date":418,"type":19},"2026-12-31",{"name":36,"class":37},""]