Clinical trial · Interventional
The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer
Comparing the Efficiency Between Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer: a Randomized, Controlled, Open-label, Single-center Phase III Clinical Trial
NCT05496166CI-TRIAL-00066497not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Limited Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- surgery group
- description
- SHR-1316+chemotherapy+surgery
- interventionNames
- Combination Product: chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- radiotherapy group
- description
- SHR-1316+chemotherapy+radiotherapy
- interventionNames
- Combination Product: chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 until ≥ 120 days after the last dose of chemotherapy or SHR-1316, whichever is later, and have ≤ 7 days of urine or Serum pregnancy test results are negative; * Unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or SHR-1316, whichever is later. Exclusion Criteria: * Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy; * Patients with other malignancies within five years prior to the start of the trial; * Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc; * With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy; * Allergy to the test drug; * Have or currently have interstitial lung disease; * Coexisting with HIV infection or active hepatitis; * Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial; * Pregnant or breastfeeding women; * Those who suffer from neurological diseases or mental illnesses who cannot cooperate; * Other reasons that investigators deem inappropriate for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.