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

NCT06680115 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024-K395-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

  2 years

Secondary Outcomes (3)

• Overall survival

  2 years

• Distant failure-free survival

  2 years

• Locoregional failure-free survival

  2 years

Study Arms (2)

Sintilimab

EXPERIMENTAL

Drug: Sintilimab

Control

NO INTERVENTION

Interventions

Sintilimab DRUG

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

Sintilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Rensheng Wang

CONTACT

86-0771-5356509; 13807806008@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 8, 2024

Record last verified: 2024-10

Locations

CN (1)