This is clinical trial evaluating the safety and efficacy of radiotherapy combined with immunotherapy and chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) and liver metastases.
All eligible patients will receive liver-directed radiotherapy, followed by PD-1/PD-L1 inhibitors plus chemotherapy. The systemic therapy is initiated concurrently with radiotherapy. PD-1/PD-L1 inhibitors and chemotherapeutic agents (such as Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) are administered intravenously every 3 weeks according to their approved product information. The treatment regimen consists of an initial concurrent phase of radiotherapy, immunotherapy, and chemotherapy, followed by a maintenance phase with PD-1/PD-L1 inhibitors alone until disease progression or for up to 24 months.Main Objective and Endpoint: The primary objective is to evaluate the objective response rate (ORR) and safety of the combination therapy. The primary endpoint is the ORR, defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria, as determined by the investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Combined With Chemotherapy( (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin) ). Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) or low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) ) followed by Immunotherapy
Combined With immunotherapy.
Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) followed by Immunotherapy
West China Hospital of Sichuan University
Chengdu, Sichuan, China
ORR
The proportion of participants who achieve a best overall response of Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by the investigator.
Time frame: From date of enrollment until the first documented date of disease progression or death from any cause (whichever occurs first), assessed up to 24 months.
Progression-Free Survival (PFS)
The time from the date of enrollment until the first documented date of disease progression as per RECIST v1.1, or death from any cause, whichever occurs first.
Time frame: From enrollment until first progression or death, assessed up to approximately 3 years.
Disease Control Rate (DCR)
The proportion of participants who achieve a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1.
Time frame: From enrollment until the first documented date of disease progression, assessed up to 24 months.
Incidence of Adverse Events (AEs)
The number and percentage of participants with any adverse event, serious adverse event, and immune-related adverse event. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: From the first dose of study treatment until 30 days after the last dose (up to approximately 25 months).
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low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) )