Induction and maintenance with MRG003, Tislelizumab, and Capecitabine for locally recurrent nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial enrolls adults with non-metastatic, locally recurrent nasopharyngeal carcinoma after previous treatment. Participants receive six weekly induction cycles of MRG003 plus tislelizumab, followed by up to one year of maintenance with capecitabine and tislelizumab, provided there is no disease progression. The study excludes those with distant metastasis or prior exposure to PD-1/PD-L1–targeted therapy and requires adequate organ function and good performance status. Primary objectives focus on safety and preliminary efficacy, with ongoing monitoring for response and adverse events. The trial is conducted at Fujian Cancer Hospital in China and is sponsored by Fujian Cancer Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\*\*Inclusion Criteria:\*\*

1. 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.
2. Age 18-70 years.
3. Pathologically confirmed local recurrence of NPC, staged as rT1-rT4 according to the 9th edition of the AJCC/UICC classification.
4. ECOG performance status score of 0-1.
5. No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent NPC.
6. No contraindications to immunotherapy or chemotherapy.
7. Adequate organ function.

Exclusion Criteria:

\*\*Exclusion Criteria:\*\*

1. Previous treatment with other PD-1 antibodies or immunotherapy targeting PD-1/PD-L1 resulting in Grade III or higher immune-related adverse reactions.
2. 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).
3. 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).
4. Known allergy to MRG003, capecitabine, or any component of anti-PD-1 antibodies.

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Qiaojuan Guo, PhD
• Email: guoqiaojuan@163.com
• Phone: 591-83638732

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.