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NOT YET RECRUITING
NCT07331428
PHASE2

MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

This study enrolls patients who have experienced local recurrence of nasopharyngeal carcinoma (NPC) with or without regional recurrence. The treatment regimen includes an induction phase with MRG003 at 2.0 mg/kg (D1) combined with Tislelizumab 200 mg (D1), administered weekly for 6 cycles. This is followed by maintenance therapy consisting of Capecitabine (650 mg/m², twice daily on days 1-21) in combination with Tislelizumab, continued for up to 1 year or until disease progression.

Official title: Efficacy and Safety of MRG003 With PD-1 Induction Followed by Capecitabine and PD-1 Maintenance as First-line Treatment in Locally Recurrent Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-01-01

Completion Date

2029-12-31

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DRUG

MRG003

MRG003 at 2.0 mg/kg (D1) will be administered every three weeks for 6 cycles

DRUG

Tislelizumab

Tislelizumab 200 mg (D1) will be administered every three weeks for 6 cycles. Upon achieving an objective response, maintenance therapy will continue for up to one year or until disease progression is observed.

DRUG

Capecitabine

After achieving an objective response (ORR) with the combination of MRG003 and Tislelizumab, maintenance therapy will consist of Capecitabine (650 mg/m², administered twice daily on Days 1-21) in conjunction with Tislelizumab. This maintenance phase will continue for up to one year or until disease progression is observed.