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Not yet recruiting NCT07310771

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

Phase II Interventional Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sintilimab combined with chemotherapy and nimotuzumab.
Who it may be relevant to
Registry conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-SCCHN). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-Arm Phase II Study of Sintilimab Plus Nimotuzumab and Chemotherapy Followed by Definitive Chemoradiotherapy With Nimotuzumab for Locally Advanced Head and Neck Squamous Cell Carcinoma

Overview

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.

Interventions

  • Drug Sintilimab combined with chemotherapy and nimotuzumab
    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.

Primary outcome measures

  • Larynx-preservation rate at 3 months post-radiotherapy [Time frame: 3 months]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.
  • Documented EGFR-positive tumor.
  • No prior systemic therapy for head and neck squamous cell carcinoma.
  • At least one measurable lesion per RECIST v1.1.
  • Estimated life expectancy ≥ 12 weeks.
  • Adequate bone-marrow and organ function.

Exclusion criteria

  • 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.
  • Failure to recover to ≤ Grade 1 (per CTCAE) from prior anti-tumour therapy-except alopecia or residual neurotoxicity related to prior platinum-before first study dose.
  • Severe infection (> CTCAE Grade 2) within 4 weeks before first study dose.
  • Active autoimmune disease or documented autoimmune-disease history requiring systemic therapy.
  • History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency syndromes, or prior solid-organ or allogeneic bone-marrow transplantation.
  • History of interstitial lung disease or non-infectious pneumonitis.
  • Evidence of active tuberculosis infection on history or CT imaging.
  • Active hepatitis B (HBV DNA ≥ 500 IU/mL or ≥ 2,500 copies/mL).
  • History of substance abuse, alcohol abuse, or drug addiction.
  • Pregnant or lactating women.
  • Any condition that, in the investigator's opinion, could necessitate premature withdrawal from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07310771 · K2025-193-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗