Work

Thalidomide dose selection for prevention of camrelizumab-induced reactive cutaneous capillary endothelial proliferation: a multicenter, randomized phase II trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Background: Reactive cutaneous capillary endothelial proliferation (RCCEP) is a characteristic cutaneous adverse event associated with immune checkpoint inhibitors. This study compared two prophylactic thalidomide doses to identify the more promising dose for further evaluation. Methods: In this multicenter, randomized clinical trial, patients with advanced esophageal squamous cell carcinoma or non-small cell lung cancer (NSCLC) were randomly assigned to receive thalidomide 50 mg/day (Group A) or 100 mg/day (Group B) during first-line treatment with camrelizumab plus standard chemotherapy. The primary endpoint was overall RCCEP incidence; secondary endpoints included grade ≥3 RCCEP, median time to RCCEP onset, week 6 and week 9 RCCEP incidence, and safety. Results: A total of 72 patients were randomized. RCCEP occurred in 12 of 36 patients (33.3%) in Group A and 9 of 36 patients (25.0%) in Group B. RCCEP incidence at week 6 was 13.9% in Group A and 19.4% in Group B, and by week 9 was 25.0% and 19.4%, respectively. No grade ≥3 RCCEP occurred; all first RCCEP events were grade 1, with 1 grade 2 event reported in Group A. Among patients who developed RCCEP, median onset time was 1.49 and 1.31 months, respectively. Thalidomide-related adverse events occurred in 22.2% and 41.7% of patients, and grade 3 or higher thalidomide-related adverse events occurred in 8.3% and 22.2%, respectively. Serious adverse events occurred in 11.1% and 13.9% of patients, respectively. Conclusion: Thalidomide 100 mg/day met the prespecified incidence-based dose-selection criterion compared with 50 mg/day but was associated with a higher incidence of grade 3 or higher toxicity. Further controlled evaluation is warranted. Clinical trial registration: https://clinicaltrials.gov/study/NCT06231680, identifier NCT06231680.

Source: Frontiers in Immunology

DOI: 10.3389/fimmu.2026.1917046