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Not yet recruiting NCT06680115

Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma

Phase II Interventional Nasopharyngeal Carcinoma (NPC)

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.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma (NPC). Basic parameters: from 18 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma: a Multicenter, Open-label, Randomized Phase II Clinical Trial

Overview

To evaluate the efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Secondary endpoints included 2-year overall survival (OS), distant failure-free survival (DFFS), locoregional failure-free survival (LRFFS), and adverse events.

Interventions

  • Drug Sintilimab
    Induction chemotherapy stage: Sintilimab combined with GP regimen chemotherapy; Adjuvant chemotherapy stage: Sintilimab combined with Capecitabine

Primary outcome measures

  • Failure-free survival [Time frame: 2 years]
Secondary outcome measures (3)
  • Overall survival [Time frame: 2 years]
  • Distant failure-free survival [Time frame: 2 years]
  • Locoregional failure-free survival [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma;
  • Age≥18 years;
  • Staging TanyN3M0 (AJCC/UICC 9th edition) ;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  • White blood cell≥3.5×10\^9/L,Neutrophils≥1.5×10\^9/L, hemoglobin≥ 90 g/L, platelet (PLT)≥ 100x10\^9/ L ;
  • Transaminases≤2.5 times the upper limit of normal, total bilirubin <1.5 times the upper limit of normal;
  • Creatinine clearance ≥60 ml/min;
  • Signed informed consent form.

Exclusion criteria

  • HBsAg positive and HBV DNA >1×103 copy/ml;
  • Patients with positive HCV antibody test results;
  • Active, known, or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, or hair loss, may be enrolled;
  • History of interstitial lung disease;
  • Received systemic sex hormone or other immunosuppressive therapy with equivalent dose > 10mg prednisone/day within 28 days before signing the informed consent. Participants with a systemic sex hormone dose ≤10mg prednisone/day or inhaled/topical corticosteroids were enrolled;
  • Have received or will receive live vaccine within 30 days before signing the informed consent;
  • Pregnant or lactating women (pregnancy tests should be considered for sexually active, fertile women);
  • Had other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer;
  • The subject is known to have a prior allergy to macromolecular protein preparations, or any of the components of sindillizumab;
  • Human immunodeficiency virus (HIV) infection;
  • Other conditions, as determined by the investigator, that may affect subjects' safety or compliance with the study include symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infection requiring systemic treatment, mental illness, or family and social factors.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Guangxi Medical University — Nanning

Identifiers

NCT: NCT06680115 · 2024-K395-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗