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Peer-reviewedCC BY 4.0Frontiers in Immunology

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

  • Xiao Fu1
  • Shuning Xu2
  • Peng Cheng3
  • Haitao Lan4
  • Yina Wang5
  • Dong Zhao6
  • Mingyue Liu7
  • Shouguo Li8
  • Weidong Liu9
  • Guiping Yu10
  • Xiaowei Wei11
  • Feilong Sun12
2 more authors
  • Yu Yao1
  • Ying Liu2
12 affiliations
  1. 1Department of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University
  2. 2Department of Digestive Diseases, Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
  3. 3Department of Oncology, The First Affiliated Hospital of Nanyang Medical College
  4. 4Department of Oncology, Sichuan Academy of Medical Sciences/Sichuan Provincial People’s Hospital
  5. 5Medical Oncology Department, The First Affiliated Hospital of Medical School of Zhejiang University
  6. 6Oncology Department, Lixin County People’s Hospital
  7. 7Medical Oncology Department, Henan Provincial People’s Hospital
  8. 8Radiation Oncology, Zhongshan Hospital Xiamen University
  9. 9Medical Oncology Department, Tangshan Central Hospital
  10. 10Medical Oncology Department, Xi’an NO. 9 Hospital
  11. 11Medical Oncology Department, Nanjing First Hospital
  12. 12Department of Medical Affairs, Jiangsu Hengrui Pharmaceuticals
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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.

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Cite

BibTeXRIS
BibTeX
@article{fu2026thalidomide,
  title = {{Thalidomide dose selection for prevention of camrelizumab-induced reactive cutaneous capillary endothelial proliferation: a multicenter, randomized phase II trial}},
  author = {Xiao Fu and Shuning Xu and Peng Cheng and Haitao Lan and Yina Wang and Dong Zhao and Mingyue Liu and Shouguo Li and Weidong Liu and Guiping Yu and Xiaowei Wei and Feilong Sun and Yu Yao and Ying Liu},
  journal = {Frontiers in Immunology},
  year = {2026},
  month = oct,
  doi = {10.3389/fimmu.2026.1917046},
  url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1917046/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Thalidomide dose selection for prevention of camrelizumab-induced reactive cutaneous capillary endothelial proliferation: a multicenter, randomized phase II trial
AU  - Xiao Fu
AU  - Shuning Xu
AU  - Peng Cheng
AU  - Haitao Lan
AU  - Yina Wang
AU  - Dong Zhao
AU  - Mingyue Liu
AU  - Shouguo Li
AU  - Weidong Liu
AU  - Guiping Yu
AU  - Xiaowei Wei
AU  - Feilong Sun
AU  - Yu Yao
AU  - Ying Liu
PY  - 2026
DA  - 2026/10/16
JO  - Frontiers in Immunology
DO  - 10.3389/fimmu.2026.1917046
UR  - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1917046/full
AB  - 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.
SN  - 1664-3224
ER  -