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Clinical Trial Summary

To evaluate the safety and efficacy of combination of Sintilimab and SBRT on the basis of platinum-containing chemotherapy as the first-line treatment of limited metastatic head and neck squamous cell carcinoma (LM-HNSCC).


Clinical Trial Description

For patients with LM-HNSCC, the conventional first-line treatment is EXTREME regimen dominated systemic therapy. In the recent era, immunotherapy has emerged to be the paramount issue for cancer treatment. A series of high-quality clinical studies demonstrated that immunotherapy (such as PD1 inhibitor) with or without chemotherapy (depending on CPS status) offered significant survival benefits to patients with recurrent or metastatic (R/M) HNSCC and the toxicities were well tolerated, whereas the PFS was still dismal. SBRT is associated with initiating release of tumor antigens, promoting DC activation, activating APCs, priming CD8+ CTLs, leading to the potential of abscopal effect. Therefore, we hypothesized that adding SBRT to Sintilimab (a PD1 inhibitor) and platinum-containing chemotherapy as the first-line treatment may improve the PFS for limited metastatic head and neck squamous cell carcinoma (LM-HNSCC). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05136768
Study type Interventional
Source Chinese Academy of Medical Sciences
Contact Junlin Yi, MD
Phone 86-10-87788792
Email yijunlin1969@163.com
Status Not yet recruiting
Phase Phase 2
Start date December 2021
Completion date December 2024

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