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NCT Number: NCT07331428

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Local Recurrence Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRG003

Drug

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

Tislelizumab

Drug

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.

Capecitabine

Drug

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 outcomes

  1. Objective Response Rate

    Time frame: Day 21 after the completion of six cycles of MRG003 treatment

    The Objective Response Rate (ORR) is defined as the proportion of patients achieving Complete Response (CR) or Partial Response (PR) by Day 21 after the completion of six cycles of MRG003 treatment, starting from the date of enrollment.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 1-year; 3-year

    PFS is defined as the time from enrollment to the date of tumor progression or death from any cause, or to the date of the last follow-up if no progression has occurred.

  2. Overall Survival (OS)

    Time frame: 1-year; 3-year

    OS is defined as the time from enrollment to the date of death from any cause, or to the date of the last follow-up if no death has occurred.

  3. Duration of Response (DOR)

    Time frame: 1-year; 3-year

    DOR is defined as the time from the first assessment of Complete Response (CR) or Partial Response (PR) to the first assessment of Progressive Disease (PD) or death from any cause

  4. Disease Control Rate (DCR)

    Time frame: Day 21 after the completion of six cycles of MRG003 treatment

    DCR is defined as the proportion of subjects who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after treatment.

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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