Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma

Summary

This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.

Conditions

• Nasopharyngeal Carcinoma

Interventions

DRUG

PD-1 antibody

Tislelizumab：200 mg per dose, intravenous infusion over 30 minutes, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy

DRUG

Capecitabine

Capecitabine : 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles after concurrent chemoradiotherapy

Sponsors & Collaborators

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Affiliated Cancer Hospital of Guizhou Medical University

  collaborator UNKNOWN

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Jun Ma, MD · Sun Yet-senU

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-17

Primary Completion

2027-06-30

Completion

2029-06-30

Countries

• China

Study Locations