NCT07258147

Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases

Clinical Study on the Efficacy and Safety of Radiotherapy Combined With Immunotherapy and Chemotherapy for Pre-treated Patients With Small Cell Lung Cancer and Liver Metastases

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer (SCLC)

Interventions

Type	Name	Description
DRUG	Immunotherapy	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
DRUG	Chemotherapy (Etoposide, Nab-paclitaxel, Irinotecan, or Lurbinectedin)	Combined With immunotherapy.
RADIATION	low-dose radiation	Liver-directed radiotherapy (low-dose radiation(3Gy\*5d) followed by Immunotherapy
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	low-dose radiation(3Gy\*5d) +stereotactic body radiation therapy (10Gy\*3d) )

Timeline

• Start date: 2025-12-25
• Primary completion: 2027-12-31
• Completion: 2028-12-30
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China