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A protocol for a randomized trial evaluating the role of carbon-ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma.
Hu, Jiyi; Huang, Qingting; Hu, Weixu; Gao, Jing; Yang, Jing; Zhang, Haojiong; Lu, Jiade Jay; Kong, Lin.
Afiliación
  • Hu J; Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
  • Huang Q; Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Shanghai, China.
  • Hu W; Shanghai Key Laboratory of radiation oncology, Shanghai, China.
  • Gao J; Shanghai Engineering Research Center of Proton and Heavy Ion Radiation Therapy, Shanghai, China.
  • Yang J; Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Fudan University Cancer Hospital, Shanghai, China.
  • Zhang H; Department of Radiation Oncology, Shanghai Proton and Heavy Ion Center, Shanghai, China.
  • Lu JJ; Shanghai Key Laboratory of radiation oncology, Shanghai, China.
  • Kong L; Shanghai Engineering Research Center of Proton and Heavy Ion Radiation Therapy, Shanghai, China.
Cancer Med ; 13(3): e6742, 2024 Feb.
Article en En | MEDLINE | ID: mdl-38205914
ABSTRACT

PURPOSE:

Management of locoregionally recurrent nasopharyngeal carcinoma (LR NPC) is difficult. Although carbon-ion radiation therapy (CIRT) could substantially improve the overall survival (OS) of those patients, around 40% of the patients may still develop local failure. Further improvement of the disease control is necessary. Immunotherapy, such as immune checkpoint inhibitors (ICIs) becomes a promising antitumor treatment. The role of ICIs was proved in head and neck cancers including recurrent/metastatic NPC. Preclinical studies indicated potential synergistic effects between radiation therapy and ICIs. Therefore, we conduct a randomized phase 2 trial to evaluate the efficacy and safety of camrelizumab, an anti-PD-1 monoclonal antibody, along with CIRT in patients with LR NPC.

METHODS:

Patients will be randomly assigned at 11 to receive either standard CIRT with 63 Gy (relatively biological effectiveness, [RBE]) in 21 fractions, or standard CIRT plus concurrent camrelizumab. Camrelizumab will be administered intravenously with a dose of 200 mg, every 2 week, for a maximum of 1 year. We estimate addition of camrelizumab will improve the 2-year progression-free survival (PFS) from 45% to 60%. A total of 146 patients (with a 5% lost to follow-up rate) is required to yield a type I error of 0.2, and a power of 0.8. RESULTS AND

CONCLUSION:

The results of the trial may shed insights on the combined therapy with ICIs and CIRT.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Nasofaríngeas / Anticuerpos Monoclonales Humanizados / Radioterapia de Iones Pesados Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Cancer Med Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Nasofaríngeas / Anticuerpos Monoclonales Humanizados / Radioterapia de Iones Pesados Tipo de estudio: Clinical_trials / Guideline Límite: Humans Idioma: En Revista: Cancer Med Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos