Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06349889

Adebrelimab and Chemoradiotherapy in High-risk LANPC

Led by Sun Yat-sen University · Updated on 2025-01-15

50

Participants Needed

4

Research Sites

196 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

N

Nanfang Hospital, Southern Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).

CONDITIONS

Official Title

Adebrelimab and Chemoradiotherapy in High-risk LANPC

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed nasopharyngeal carcinoma.
  • Tumor staged as IVA+T3N2M0 (AJCC 8th).
  • Eastern Cooperative Oncology Group performance status 1 or less.
  • Adequate marrow function: neutrocyte count at least 1.5 x 10^9/L, hemoglobin at least 90 g/L, and platelet count at least 100 x 10^9/L.
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels no more than 2.5 times the upper limit of normal, and bilirubin no more than 1.5 times the upper limit of normal.
  • Adequate kidney function with creatinine clearance rate at least 60 ml/min.
  • Patients must give written informed consent after being informed about the investigational nature of the study.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during treatment and for 1 year after the last dose.
Not Eligible

You will not qualify if you...

  • Age under 18 or over 65.
  • Positive for hepatitis B surface antigen with hepatitis B virus DNA over 1 x 10^3 copies/ml or 200 IU/ml.
  • Positive for hepatitis C virus antibody.
  • Active autoimmune disease requiring systemic treatment, except type I diabetes, hypothyroidism treated with replacement therapy, or certain skin diseases not needing systemic treatment.
  • Use of systemic corticosteroids equivalent to prednisone over 10 mg/day or other immunosuppressive therapy within 28 days before consent.
  • History of active tuberculosis within the past year.
  • History of interstitial lung disease.
  • Receipt of live vaccine within 30 days before consent or planned live vaccine use soon.
  • Pregnant or breastfeeding women.
  • Diagnosis of another malignancy within 5 years, except certain treated cancers.
  • Known allergy to Adebrelimab or its components.
  • Known HIV infection.
  • Any other medical or social condition that could interfere with study participation or result interpretation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361003

Actively Recruiting

2

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

3

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510000

Actively Recruiting

4

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

J

Jun Ma, M.D.

CONTACT

L

Lei Chen, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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