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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma (NPC)
• Intervention / Treatment: Drug: Sintilimab

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rensheng Wang; Phone Number: 86-0771-5356509; Email: 13807806008@163.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Rensheng Wang; Phone Number: 86+0771-5356509; Email: 13807806008@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. HBsAg positive and HBV DNA >1×103 copy/ml;
2. Patients with positive HCV antibody test results;
3. 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;
4. History of interstitial lung disease;
5. 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;
6. Have received or will receive live vaccine within 30 days before signing the informed consent;
7. Pregnant or lactating women (pregnancy tests should be considered for sexually active, fertile women);
8. Had other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer;
9. The subject is known to have a prior allergy to macromolecular protein preparations, or any of the components of sindillizumab;
10. Human immunodeficiency virus (HIV) infection;
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Sintilimab	Drug: Sintilimab; Induction chemotherapy stage: Sintilimab combined with GP regimen chemotherapy; Adjuvant chemotherapy stage: Sintilimab combined with Capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Failure-free survival	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	2 years
Distant failure-free survival	2 years
Locoregional failure-free survival	2 years

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Carcinoma
• Other Study ID Numbers: 2024-K395-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No