NCT07173244

A Real-world Study of Adebrelimab-based Combination Regimens in the Treatment of Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Tianjin First Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multicenter, non-interventional, observational, real-world study was designed to evaluate the safety and efficacy of an adebrelimab-based regimen in patients with advanced solid tumors.

Detailed description

This prospective, multicenter, non-interventional, observational, real-world study aims to evaluate the safety and efficacy of adebrelimab in patients with advanced solid tumors. The study is expected to enroll 300 patients with advanced solid tumors. Information on demographics, previous treatment history, adebrelimab-containing treatment regimens, clinical outcomes, and adverse events will be collected for all enrolled patients. Patients must have a clinically confirmed diagnosis of locally advanced, recurrent, or metastatic cancer, including but not limited to non-small cell lung cancer, small cell lung cancer, and gastrointestinal cancers (esophageal, gastric, liver, biliary, pancreatic, and intestinal cancers). Patients had already decided to receive adebrelimab before enrollment. Based on their tumor type, stage, and previous treatment history, they were assigned to one of two cohorts: Cohort 1: First-line treatment with adebrelimab combined with etoposide and carboplatin for extensive-stage small cell lung cancer; Cohort 2: Other solid tumors treated with an adebrelimab-based regimen (excluding central nervous system, urinary, bone, soft tissue sarcomas, and skin tumors such as melanoma). The adebrelimab regimen in Cohort 1 was 1200 mg intravenously infused every 21 days. The adebrelimab regimen in Cohort 2 was based on the instructions. Patients were followed up until loss to follow-up, death, withdrawal of consent, or study termination/closure, whichever occurred first. This study was a non-interventional, real-world study. The diagnosis and treatment process, visits, and examinations were based on routine clinical experience, and no intervention was made on patients' medication choices. The data for this study were primarily sourced from patients' daily diagnosis and treatment records.

Conditions

• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Gastrointestinal Cancers

Interventions

Type	Name	Description
DRUG	Adebrelimab	adebrelimab-based regimen

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2025-09-15
• Last updated: 2025-09-15