Although multiple immune-checkpoint inhibitors (ICIs) have demonstrated efficacy in recurrent or metastatic squamous-cell carcinoma of the head and neck (R/M-SCCHN), outcomes in the locally advanced (LA-SCCHN) setting remain suboptimal, and treatment continues to pose a major therapeutic challenge. Incremental improvements in efficacy are still required, necessitating the development of more effective regimens. Whether combining an ICI with chemotherapy and nimotuzumab can confer additional clinical benefit in LA-SCCHN remains to be determined. Against this backdrop, we designed a single-arm, phase II, single-centre clinical trial to evaluate the efficacy and safety of sintilimab plus chemotherapy and nimotuzumab for patients with LA-SCCHN.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
The study plans to enroll patients with locally advanced squamous cell carcinoma of the head and neck. After induction with sintilimab plus paclitaxel, cisplatin, and nimotuzumab, participants will receive concurrent chemoradiotherapy with nimotuzumab, followed by maintenance sintilimab monotherapy until disease progression, unacceptable toxicity, death, or withdrawal of consent.
Larynx-preservation rate at 3 months post-radiotherapy
Time frame: 3 months
objective response rate
Time frame: 24 months
One-year progression-free survival (PFS) rates
Time frame: 12 months
Two-year progression-free survival (PFS) rates
Time frame: 24 months
One-year loco-regional relapse-free survival (LRFS) rates.
Time frame: 12 months
two-year loco-regional relapse-free survival (LRFS) rates.
Time frame: 24 months
One- year distant-metastasis-free survival (DMFS) rates.
Time frame: 12 months
two-year distant-metastasis-free survival (DMFS) rates
Time frame: 24 months
One-year larynx-preservation rates
Time frame: 12 months
AE/SAE
Time frame: 42 months
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