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

NCT ID: NCT06680115

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2029-12-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sintilimab

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Countries

China

Central Contacts

Rensheng Wang

Role: CONTACT

13807806008@163.com

86-0771-5356509

Facility Contacts

Rensheng Wang

Role: primary

13807806008@163.com

86+0771-5356509

Other Identifiers

2024-K395-01

Identifier Type: -

Identifier Source: org_study_id