The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing D… (NCT05496166) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer
China348 participantsStarted 2023-08-01
Plain-language summary
To compare the efficiency between surgery and radiotherapy after SHR-1316 (Adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* after signing informed consent;
* Aged 18-70;
* Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;
* For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.
* Two thoracic surgeons assessed thar it would be able to achieve radical surgery or R0 resection after 4 cycles of treatment. Surgical approaches include lobectomy, sleeve resection and pneumonectomy
* ECOG performance status score 0-1 points;
* With a life expectancy of at least 12 weeks;
* At least one measurable tumor
* With normal Other major organs (liver, kidney, blood system, etc.) function:
Absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90 g/L. Note: Patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period;
\- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Serum total bilirubin ≤ 1.5×ULN (total bilirubin in patients with Gilbert syndrome must be \<3×ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN, or AST and ALT ≤5×ULN in patients with liver metastases
* Female patients of childbearing potential must voluntarily use highly effective contraception during the study period unti…
What they're measuring
1
progression-free survival
Timeframe: 2 years
Trial details
NCT IDNCT05496166
SponsorShanghai Pulmonary Hospital, Shanghai, China