A Single-arm, Prospective, Exploratory Study of Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer and Analysis of Biological Markers(ASSESS)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75 years old; Histologically or cytologically confirmed as limited-stage small cell lung cancer (T1-3N0-1M0); All lesions of the patient (including primary lesions, lymph nodes/metastatic lesions assessed as metastases) must be jointly evaluated by surgeons, radiotherapists, and radiologists to be surgically resectable; Subjects must have measurable target lesions (according to RECIST 1.1 standards); ECOG performance status score 0-1; No history of other malignant tumors; No previous anti-tumor treatment such as surgery, radiotherapy, chemotherapy, immunotherapy, etc. related to small cell lung cancer; Patients must have sufficient cardiopulmonary function: FEV1 and DLCO of patients are ≥50% of the predicted value, echocardiography indicates LVEF ≥55%, and no clear signs of heart failure, severe coronary artery stenosis, etc. are found in various tests. Cardiopulmonary function is assessed by surgeons to be able to tolerate surgical treatment;

‣ The functional level of each important organ must meet the following requirements:

⁃ Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelets ≥100 × 109/L, hemoglobin ≥9 g/dl;

⁃ Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;

⁃ Liver: total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;

⁃ Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min; Men of childbearing potential and women of childbearing age must agree to take effective contraceptive measures from the signing of the main informed consent until 180 days after the last dose of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within ≤ 7 days before the first administration of the study drug; Voluntarily participate in the clinical study; fully understand and be informed of this study and sign the ICF (Informed Consent Form).

Locations
Other Locations
China
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Contact Information
Primary
jinshi liu
liujs@zjcc.org.cn
057188122233
Backup
dijian shen
shendj@zjcc.org.cn
13486199461
Time Frame
Start Date: 2024-07-24
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 20
Treatments
Experimental: neoadjuvant anti-PDL-1 Immunotherapy combined chemotherapy and SBRT
Three cycles of neoadjuvant PDL-1 combined chemotherapy and SBRT followed by surgery for limited-stage small cell lung cancer
Sponsors
Leads: Zhejiang Cancer Hospital

This content was sourced from clinicaltrials.gov