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Not yet recruiting NCT07331428

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

Phase II Interventional Nasopharyngeal Carcinoma Local Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRG003, Tislelizumab, Capecitabine.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma, Local Recurrence. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Primary outcome measures

  • Objective Response Rate [Time frame: Day 21 after the completion of six cycles of MRG003 treatment]
Secondary outcome measures (4)
  • Progression-Free Survival (PFS) [Time frame: 1-year; 3-year]
  • Overall Survival (OS) [Time frame: 1-year; 3-year]
  • Duration of Response (DOR) [Time frame: 1-year; 3-year]
  • Disease Control Rate (DCR) [Time frame: Day 21 after the completion of six cycles of MRG003 treatment]

Eligibility criteria

Inclusion criteria

\*\*Inclusion Criteria:\*\*

  • Patients with locally recurrent nasopharyngeal carcinoma (NPC) more than 1 year after initial radical treatment for non-metastatic NPC, with or without regional recurrence, but without distant metastasis.
  • Age 18-70 years.
  • Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC/UICC classification.
  • ECOG performance status score of 0-1.
  • No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent NPC.
  • No contraindications to immunotherapy or chemotherapy.
  • Adequate organ function.

Exclusion criteria

\*\*Exclusion Criteria:\*\*

  • Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1/PD-L1 resulting in Grade III or higher immune-related adverse reactions.
  • Residual toxic effects from prior anti-tumor treatments (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy) (excluding alopecia, fatigue, and Grade 2 hypothyroidism) or clinically significant laboratory abnormalities higher than Grade 1 (CTCAE v5.0).
  • Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥10 copies/ml), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the detection limit of the assay).
  • Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07331428 · 2025-12-19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗