[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591263":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":34,"collaborators":24,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":24,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":24,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":24,"overallStatus":55,"whyStopped":24,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":24},{"fullName":5,"class":6},"Tang-Du Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib)","EXPERIMENTAL","Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day 1. Anlotinib, 10 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Etoposide, 100mg\u002Fm2, day 1\\~3. Cisplatin, 75mg\u002Fm2，day 1; or Carboplatin, AUC 5, day 1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 10 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week.",[13],"Drug: benmelstobart combined with chemotherapy and anlotinib",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy)","Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; Etoposide, 100mg\u002Fm2, day 1\\~3; Cisplatin, 75mg\u002Fm2，day 1; or Carboplatin, AUC 5, day 1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1.",[18],"Drug: benmelstobart combined with chemotherapy",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","benmelstobart combined with chemotherapy and anlotinib",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"benmelstobart combined with chemotherapy",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Yan Xiaolong Yan","CONTACT","+8615991269383","yanxiaolong@fmmu.edu.cn",{"type":35,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100591263","phase-2-this-is-a-two-cohort-exploratory-clinical-study-assessing-the-activity-of-benmelstobart-combined-with-chemotherapy-with-or-without-anlotinib-in-resectable-limited-stage-small-cell-lung-cancer-100591263",false,"NCT06978153","This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer","Perioperative Treatment With Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer: A Randomized, Two-Cohort, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n* Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.\n* Aged 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.\n* Histologically confirmed small cell lung cancer (SCLC).\n* Confirmed as stage I-IIIB SCLC (T1-3N0-2M0) per AJCC 9th Edition.\n* Patients who have received 1 cycle of chemotherapy are eligible; no other prior treatments are permitted.\n* ECOG Performance Status (PS) 0 or 1.\n* Assessed by the investigator as having no surgical contraindications.\n* At least one measurable lesion per RECIST 1.1 criteria.\n* Expected survival ≥8 weeks.\n* Women of childbearing potential (aged 15-49) must have a negative serum pregnancy test within 7 days before treatment initiation and agree to use reliable contraception during the study until 8 weeks after discontinuation. Normal function of major organs meeting the following criteria:\n* Hematologic tests (no blood transfusion, blood products, G-CSF, or hematopoietic stimulants within 14 days): Hemoglobin (Hb) ≥90 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelets (PLT) ≥80×10⁹\u002FL.\n* Biochemical tests meeting: Total bilirubin (TBIL) ≤1.5×ULN; ALT\u002FAST ≤2.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 mL\u002Fmin.\n* Urine protein \\\u003C2+; for patients not on anticoagulation: INR ≤1.5, APTT ≤1.5×ULN. Patients on full-dose or parenteral anticoagulants may enroll if dosing has been stable for ≥2 weeks and coagulation tests are within therapeutic ranges.\n\nExclusion Criteria:\n\n* Histologically confirmed mixed-type SCLC.\n* Extensive-stage SCLC.\n* ECOG PS \\>1.\n* Active or untreated CNS metastases confirmed by CT\u002FMRI during screening\u002Fprior imaging.\n* Uncontrolled tumor-related pain.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage (≥1×\u002Fmonth).\n* Uncontrolled\u002Fsymptomatic hypercalcemia (ionized calcium \\>1.5 mmol\u002FL, calcium \\>12 mg\u002FdL, or corrected serum calcium \\>ULN).\n* Systemic immunostimulants (e.g., IFN-α, IL-2, TNF) within 4 weeks prior to enrollment (cancer vaccines allowed if prior).\n* Systemic corticosteroids (\\>10 mg prednisone\u002Fday or equivalent) or immunosuppressants within 14 days, except: Replacement therapy (≤10 mg prednisone\u002Fday); Topical\u002Focular\u002Fintra-articular\u002Fnasal\u002Finhaled steroids with minimal systemic absorption; Short-term (≤7 days) prophylactic use (e.g., contrast allergy) or for non-autoimmune conditions.\n* Imaging-confirmed tumor invasion of major vessels or high risk of fatal hemorrhage per investigator; or cavitary\u002Fnecrotic lung tumors.\n* Other malignancies within 5 years except: cervical CIS, cured basal cell carcinoma, Ta\u002FTis bladder tumors.\n* Prior use of anlotinib or other antiangiogenic agents.\n* Prior anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies or other T-cell co-stimulation\u002Fcheckpoint pathway therapies (e.g., ICOS, CD40\u002FCD137\u002FGITR\u002FOX40 agonists).\n* Hypersensitivity to anlotinib or benmelstobart components.\n* Factors impairing oral drug intake (e.g., dysphagia, chronic diarrhea, intestinal obstruction).\n* Uncontrolled comorbidities including:\n\n  1. Poorly controlled hypertension (SBP ≥150 mmHg, DBP ≥100 mmHg);\n  2. Grade ≥1 myocardial ischemia\u002Finfarction, arrhythmias (QTc ≥480 ms), or ≥NYHA Class II heart failure;\n  3. Abnormal coagulation (INR \\>1.5, PT \\>ULN+4s, APTT \\>1.5×ULN), bleeding tendency, or thrombolytic\u002Fanticoagulant therapy (prophylactic low-dose heparin \\[6,000-12,000 U\u002Fday\\] or aspirin \\[≤100 mg\u002Fday\\] allowed if INR ≤1.5);\n  4. Active\u002Fsevere uncontrolled infections;\n  5. Cirrhosis, decompensated liver disease, active\u002Fchronic hepatitis requiring antivirals;\n  6. Renal failure requiring dialysis;\n  7. Immunodeficiency (HIV+, congenital\u002Facquired immunodeficiency) or organ transplant history;\n  8. Poorly controlled diabetes (FBG \\>10 mmol\u002FL);\n  9. Urine protein ≥++ or 24-h urine protein \\>1.0 g;\n  10. Epilepsy requiring treatment;\n  11. Non-healing wounds\u002Ffractures.\n* Significant hemoptysis (\\>50 mL\u002Fday within 2 weeks) or clinically significant bleeding (e.g., GI bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++).\n* Interstitial lung disease (ILD), drug-induced ILD, steroid-requiring radiation pneumonitis, or active ILD.\n* Arterial\u002Fvenous thromboembolism within 6 months (e.g., stroke \\[including TIA\\], DVT, PE).\n* Grade ≥2 peripheral neuropathy (excluding trauma-related).\n* Major surgery\u002Fsevere trauma with residual effects within 14 days.\n* Concurrent clinical trials or \\\u003C4 weeks from prior trial treatment.\n* Live\u002Fattenuated vaccination within 30 days before benmelstobart or planned during study.\n* History of severe hypersensitivity to monoclonal antibodies.\n* Pregnant\u002Flactating women.\n* Uncontrolled psychiatric\u002Fneurological disorders affecting compliance.\n* Other factors per investigator judgment that may lead to study termination (e.g., severe illness, lab abnormalities, or social\u002Ffamily constraints compromising safety\u002Fdata collection).","ALL","18 Years","75 Years",{"count":47,"type":48},66,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle). Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) .",[54],"Limited Stage Small Cell Lung Cancer","NOT_YET_RECRUITING","2025-05-10",{"date":58,"type":59},"2025-05-18","ACTUAL",{"date":61,"type":48},"2025-05-20",{"date":63,"type":48},"2027-11-01",{"name":5,"class":6}]