Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase II
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Provision of written informed consent, with full understanding of and agreement to comply with study requirements and the visit schedule.
Age 18-75 years (inclusive) at the time of informed consent; either sex.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Histologically or cytologically confirmed stage III-IVB squamous cell carcinoma of the head and neck as assessed by the investigator.
Disqualifiers
Known hypersensitivity to any component of PD(L)-1 inhibitors, paclitaxel, or cisplatin.
Prior or concurrent malignancy (except adequately treated basal-cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma disease-free for >5 years).
Uncontrolled cardiac symptoms or clinically significant cardiac disease.
Previous therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or receipt of therapeutic cancer vaccines or live vaccines within 4 weeks before first study-dose administration.
Trial design
Treatments tested in this trial
- Sintilimab combined with chemotherapy and nimotuzumab
Treatment groups
23 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov