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Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma

ConditionHead and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

About this trial

A multicenter, randomized, controlled, open-label, Phase II/III clinical trial designed to evaluate the efficacy and safety of postoperative radiotherapy combined with Nimotuzumab,with or without Bemcentinib, in postoperative head and neck squamouscell cancer patients with intermediate-risk pathological factor. The primary endpoint is the 3-year disease-freesurvival (DFS). A total of 193 patients will be enrolled in both the experimental and control groups, resulting in a total planned enrollment of 386 patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

ECOG performance status: 0-2

Histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx); oropharyngeal cancer must be p16-negative (p16 positivity defined as ≥70% staining)

Expected survival time ≥ 6 months;

Disqualifiers

Pregnancy or lactation, or intention to become pregnant during the study period.

Presence of active autoimmune disease or immunodeficiency, including but not limited to: myasthenia gravis, interstitial pneumonia, enteritis, autoimmune hepatitis, hypophysitis, vasculitis, nephritis, or hyperthyroidism.

Known human immunodeficiency virus (HIV) infection, history of autoimmune diseases, or history of organ transplantation.

Use of systemic immunosuppressive drugs within 2 weeks prior to initiation of study treatment, or anticipated need for systemic immunosuppressive therapy during the study treatment period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nimotuzumab

    Drug

    Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles.

  • Nimotuzumab, Benmelstobart

    Drug

    Nimotuzumab: 200 mg on Day 1, once weekly (QW) for a total of 6 cycles. Bemcentinib: 1200 mg on Day 1, every 3 weeks (Q3W) for a total of 9 cycles, initiated 3-4 weeks after completion of radiotherapy.

  • Postoperative Radiotherapy

    Radiation

    Intensity-modulated radiation therapy (IMRT) will be administered at a total dose of 60Gy (2 Gy per fraction, 30 fractions)

Treatment groups

386 Participants
are divided into 2 treatment groups
Group A: IMRT-Nimotuzumab + BenmelstobartExperimental treatment 2 interventions
Group B: IMRT-NimotuzumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Disease-Free Survival (DFS）

From randomization until disease recurrence, metastasis, second primary cancer, or death from any cause

Time frame
3-year

Secondary outcomes

1

Overall Survival (OS)

From enrollment until death from any cause

Time frame
3-year
2

Adverse Events (AEs)

From the first dose of nimotuzumab through 30 days after the last dose (approximately 8 weeks total).

Time frame
30 days after the last dose (approximately 8 weeks total).
3

Locoregional Recurrence-Free Survival (LRRFS)

Time frame
From enrollment until first locoregional recurrence, assessed up to 3 years after last patient enrolled
4

Distant Metastasis-Free Survival (DMFS)

Time frame
From enrollment until first distant metastasis, assessed up to 3 years after last patient enrolled

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Lead sponsor

Source ClinicalTrials.gov

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