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Sintilimab-Nimotuzumab Induction Followed by Chemoradiation-Nimotuzumab in LA-HNSCC: Single-Arm Phase II

ConditionLocally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sintilimab combined with chemotherapy and nimotuzumab

    Drug

    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.

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: Sintilimab combined with chemotherapy and nimotuzumab for patients with LA-SCCHNExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Larynx-preservation rate at 3 months post-radiotherapy

Time frame
3 months

Secondary outcomes

1

objective response rate

Time frame
24 months
2

One-year progression-free survival (PFS) rates

Time frame
12 months
3

Two-year progression-free survival (PFS) rates

Time frame
24 months
4

One-year loco-regional relapse-free survival (LRFS) rates.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: