[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"second-line-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:second-line-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100617589","phase-2-carilizumab-and-albumin-paclitaxel-for-second-line-treatment-of-advanced-gastric-cancer-100617589",false,"NCT07320586","Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer","Clinical Study on the Combination of Carilizumab and Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer Patients Who Have Received\u002FNot Received Immunotherapy in the Past","Inclusion Criteria:\n\n1. Age range: 18 to 75 years old, both male and female are acceptable;\n2. Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology;\n3. Gastric cancer patients who have previously received first-line systemic chemotherapy (queue 1) or systemic chemotherapy combined with immunotherapy (queue 2) for progression; For intervention group 2, the best response to first-line immunotherapy is CR or PR or SD ≥ 3 months;\n4. According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed);\n5. ECOG score: 0-1 point;\n6. Expected survival period ≥ 12 weeks;\n7. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109\u002FL (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109\u002FL, hemoglobin ≥ 90g\u002FL; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml\u002Fmin\u002F1.73 m2 (calculated according to the Cockcroft Gault formula);\n8. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period, at least 6 months after the last use of Carilizumab, and at least 6 months after the last use of chemotherapy;\n9. HER2 negative;\n10. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. History of gastrointestinal perforation and\u002For fistula within 6 months prior to the first use of medication;\n2. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;\n3. History of allergies to monoclonal antibodies, any component of Carilizumab, or albumin bound paclitaxel;\n4. Have received any of the following treatments:\n\n   1. Patients who have experienced serious adverse reactions to immunotherapy in the past and are deemed unsuitable for continued use of immunotherapy by the researchers;\n   2. Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug;\n   3. Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up;\n   4. Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug;\n   5. Subjects who need to receive corticosteroids (equivalent to\\>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg\u002Fday of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones;\n   6. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug;\n   7. Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug;\n   8. Patients who have received previous treatment with paclitaxel drugs;\n5. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion\u002Fexclusion criteria;\n6. Patients with central nervous system metastases;\n7. Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma\u002Fallergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;\n8. Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU\u002Fml or 2500 copies\u002FmL);\n9. The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;\n10. Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0\\>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics;\n11. History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);\n12. Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;\n13. Diagnosed with any other malignant tumor within 5 years prior to the first use of the investigational drug, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate\\>90%), such as basal cell or squamous cell carcinoma or cervical carcinoma in situ that have been adequately treated;\n14. Pregnant or lactating women;\n15. According to the researcher's assessment, there may be other factors that could force the subject to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data.\n16. According to the researcher's assessment, there may be other factors that could force the subject to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data.","ALL","18 Years","75 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study was an open, single center, prospective cohort study design. Subjects with advanced gastric cancer who had received first-line chemotherapy (cohort 1) and systematic chemotherapy combined with immunotherapy (cohort 2) were included in this study. 20 cases were included in each population, and a total of 40 subjects were planned to be included.",[27,28],"Gastric Cancer","Second-line Therapy",[30,31],"Immune checkpoint inhibitors；","Camrelizumab","RECRUITING","2026-03-11",{"date":35,"type":36},"2026-03-13","ACTUAL",{"date":38,"type":36},"2021-03-01",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"Shandong Tumor Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100619348","phase-2-a-single-arm-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-sacituzumab-tirumotecan-in-second-line-and-subsequent-treatments-for-advanced-thymic-epithelial-tumors-100619348","NCT07343453","A Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan in Second-Line and Subsequent Treatments for Advanced Thymic Epithelial Tumors","Inclusion Criteria:\n\n1. Advanced (unresectable or metastatic) thymic epithelial tumor confirmed by histology or cytology.\n2. Progress after receiving at least first-line systemic therapy (chemotherapy or immune checkpoint inhibitor).\n3. According to RECISTv1.1 standard, there is at least one measurable lesion.\n4. No central nervous system metastasis or stable brain metastasis after treatment (asymptomatic and hormone withdrawal for ≥4 weeks).\n5. Age \\> 18 years old, male or female.\n6. ECOG (Performance status, PS) score 0-1.\n7. Expected survival time ≥12 weeks.\n8. Organ function compliance (confirmed by laboratory examination within 14 days before treatment): Bone marrow function: I. Neutrophils ≥ 1500× 109\u002FL; Ii. Platelets ≥ 100× 109\u002FL; Iii. hemoglobin \\> 90g\u002Fl; Renal function: I. Serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl). ≥50mL\u002Fmin； Ii. Urine protein \\\u003C 2+or 24H urine protein quantitative \\\u003C \\\u003C1.0g；; Liver function: I, AST or ALT ≤ 3× ULN; For patients with liver metastasis, it can ≤5\\*ULN； Ii. Total bilirubin ≤1.5×ULN, and liver metastasis patients ≤ 3× ULN; Iii: serum albumin (ALB) ≥ 28g\u002Fl; Coagulation function: NR or APTT≤1.5×ULN；; Cardiac function: Left ejection fraction (LEFF) ≥ 50%.\n9. Before making any evaluation related to the study, the subjects must understand and volunteer. Sign the informed consent form and voluntarily comply with other requirements of the study.\n10. Female subjects with reproductive function must be treated within 3 days before the first medication. Urine or serum pregnancy test (if the result of urine pregnancy test cannot be confirmed as negative, serum pregnancy test is needed, and the serum pregnancy result shall prevail). If a fertile woman has sex with an unsterilized male partner, the subjects agree to continue using contraception and avoid breastfeeding during the medication.\n11. Male subjects are willing to agree to continue using contraception during the medication.\n\nExclusion Criteria:\n\n1. Previously received targeted drug therapy with Lucasatuzumab.\n2. Have received any drug therapy targeting topoisomerase I in the past, including antibody-coupled drug (ADC) therapy.\n3. Patients with grade 3-4 interstitial lung disease.\n4. Subjects known to have meningeal metastasis, brain stem metastasis, spinal cord metastasis and\u002For compression, active or brain metastasis without local treatment. 5.Subjects with brain metastases who have previously received local treatment can participate in the study if they are clinically stable for at least 4 weeks before the first administration of the study treatment and do not need to use corticosteroids or anticonvulsants for at least 14 days before the first administration; For the subjects with brain metastases first discovered during screening, if they receive local treatment (such as radiotherapy), they must have imaging evidence to show that the brain metastases have not progressed for at least 4 weeks from the first imaging diagnosis of brain metastases, and they can only enter the group after confirming that the brain metastases are stable.\n5. Patients with previous malignant tumors (except skin malignant tumors other than melanoma, and carcinoma in situ in the following parts \\[bladder, stomach, colorectal cancer, endometrium, cervix, melanoma or breast\\]) cannot be included in this study. However, if the malignant tumor has achieved complete remission for five years or more, and no additional anti-tumor treatment is needed during this study, it can be included in the study.\n6. Myocardial infarction and uncontrolled arrhythmia occurred within 6 months before the first administration (including QTc interval ≥450ms for men and ≥ 470 ms for women) (QTc interval is calculated by Fridericia formula); Or grade III-IV cardiac insufficiency according to NYHA standard or left ventricular ejection fraction \\\u003C 50% by color Doppler echocardiography.\n7. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage. Only a small amount of pleural effusion, a small amount of ascites and a small amount of pericardial effusion without clinical symptoms shown by imaging can be included in the group.\n8. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding.\n9. Patients with active hepatitis B, hepatitis C, tuberculosis and syphilis or other serious infections with poor clinical control.\n10. HIV positive or diagnosed with acquired immunodeficiency disease (AIDS).\n11. Known allergic to the study drug or any of its components (including polysorbate -20), known history of severe hypersensitivity to other monoclonal antibodies (NCI-CTCAE5.0 grade is greater than grade 3).\n12. Before the first administration, he was receiving long-term systemic corticosteroid therapy of \\> 10mg of prednisone or equivalent dose of systemic corticosteroid therapy or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy. Subjects who need bronchodilators, inhaled or topical steroids or local steroid injections, and who are used as preventive drugs for hypersensitivity (such as drugs before CT examination) may be admitted into the group.\n13. Known history of hereditary bleeding tendency disease or coagulation dysfunction.\n14. Pregnant or lactating women.\n15. During the screening before the first administration, the condition deteriorated rapidly, such as serious changes in physical state.\n16. The researcher thinks that the patient can't finish the study medically, psychologically or physically or can't understand the information in the patient manual.\n17. Those who have been vaccinated with live or attenuated vaccines within 28 days before the first administration or have plans to vaccinate such vaccines during the study period; However, inactivated virus vaccines for seasonal influenza are allowed to be used.",{"count":52,"type":21},38,[24],"This is a single-arm, phase II study to evaluate the efficacy and safety of Sacituzumab Tirumotecan, a TROP2-directed antibody-drug conjugate, in patients with advanced thymic epithelial tumors who have received second-line or later therapy.",[56,57,28],"Thymic Epithelial Tumors","Advanced Stage","NOT_YET_RECRUITING","2026-01-06",{"date":61,"type":36},"2026-01-15",{"date":63,"type":21},"2025-12-22",{"date":65,"type":21},"2029-12-22",{"name":67,"class":43},"Sun Yat-sen University"]