Tislelizumab plus capecitabine for nasopharyngeal cancer with leftover EBV DNA after radiation

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 is a single-center, phase 2 interventional adjuvant trial enrolling adults with histologically confirmed nasopharyngeal carcinoma who have detectable plasma EBV DNA shortly before or after completing definitive radiotherapy. Enrolled patients with good performance status and adequate organ function will receive combined tislelizumab (a PD-1 inhibitor) and capecitabine with planned safety and efficacy follow-up. The primary focus is to determine whether the combination can clear residual viral DNA and reduce early recurrence while monitoring treatment-related toxicity. The trial is led by Fudan University Shanghai Cancer Centre and targets patients able to attend visits at that site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years;
2. Histologically confirmed nasopharyngeal carcinoma;
3. Expected survival time ≥12 weeks;
4. ECOG performance status: 0-1;
5. Received definitive radiotherapy (± induction and/or concurrent chemotherapy);
6. Plasma EBV DNA \>0 copies/mL within the period from 1 week before to 4 weeks after completion of radiotherapy ;
7. Adequate organ function meeting the following criteria: Hematological: a. Hemoglobin (HB) ≥90 g/L; b. Absolute neutrophil count (ANC) ≥1.0×10⁹/L; c. Platelet count (PLT) ≥80×10⁹/L; Biochemical: a. Total bilirubin (BIL) \<1.5× upper limit of normal (ULN); b. ALT and AST \<2.5×ULN; c. Serum creatinine (Cr) ≤ULN, and creatinine clearance rate ≥50 mL/min (calculated by Cockcroft-Gault formula); d. Normal myocardial enzymes and thyroid function; e. Normal cardiac function assessed by echocardiography.
8. Signed informed consent with willingness to comply with the study protocol.

Exclusion Criteria:

1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)；
2. Distant metastasis detected by pre-treatment clinical or imaging examinations;
3. History of allergy to any component of monoclonal antibodies, tislelizumab, or capecitabine;
4. History of autoimmune diseases, except for the following conditions (eligible after evaluation):

   1. Autoimmune-related hypothyroidism on stable thyroid hormone replacement therapy;
   2. Type I diabetes mellitus under stable insulin therapy with controlled blood glucose;
5. Previous or concurrent malignancies (except those cured and disease-free for \>5 years, e.g., basal cell carcinoma, cervical carcinoma in situ);
6. Positive pregnancy test in women of childbearing potential;
7. Concurrent medical conditions that may compromise patient enrollment or safety during the study;
8. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, idiopathic pneumonia, or other active pulmonary diseases;
9. Active psychiatric disorders or other mental conditions affecting informed consent comprehension;
10. Uncontrolled active infections, including tuberculosis, hepatitis B (HBsAg+), hepatitis C, or HIV (HIV antibody+);
11. Significant cardiovascular diseases: NYHA Class II or higher, myocardial infarction within 1 year, unstable angina, or supraventricular/ventricular arrhythmias requiring clinical intervention;
12. Factors affecting drug administration, distribution, metabolism, or excretion (e.g., psychiatric/neurological disorders, chronic diarrhea, ascites, pleural effusion);
13. Unwillingness to sign informed consent.

Where it's running

• Fudan Universtiy Shanghai Cancer Centre
  Shanghai, China, China Recruiting

Study contacts

• Study coordinator: Hongmei Ying
• Email: yinghongmei2013@163.com
• Phone: +8602164175590-86703

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Focused radiation plus nimotuzumab followed by tislelizumab for oligoprogressive recurrent or metastatic nasopharyngeal cancer after prior immunotherapy

  This trial will try focused stereotactic radiation together with the antibody nimotuzumab, followed by the PD‑1 drug tislelizumab, in people whose recurrent or metastatic nasopharyngeal cancer has progressed at 1–5 spots after prior anti–PD‑1 treatment.

  Recruiting Phase 2 The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT06676722

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

  This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.

  Recruiting Phase 3 CSPC Megalith Biopharmaceutical Co.,Ltd. · Guangzhou, Guangzhou · NCT07925021

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

• Tislelizumab plus Anlotinib after chemoradiotherapy in limited-stage SCLC

  This phase II trial tests whether adding tislelizumab and anlotinib after chemoradiotherapy helps people with limited-stage small cell lung cancer stay cancer-free.

  Recruiting Phase 2 Yantai Yuhuangding Hospital · Yantai, Shandong · NCT07815223

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

  This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.

  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

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.