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Recruiting Phase 2 NCT06592599

Gemcitabine + Docetaxel + Toripalimab Induction in Epstein-Barr Virus (EBV) Associated Nasopharyngeal Carcinoma(NPC)

Trial Parameters

Condition Nasopharyngeal Carcinoma
Sponsor Stanford University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 24
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-09-03
Completion 2029-01
Interventions
ToripalimabConcurrent Chemoradiation and Adjuvant treatment following Chemoradiation

Brief Summary

The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.

Eligibility Criteria

Inclusion Criteria: 1. Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8 2. Prior therapy: None for NPC permitted 3. Life expectancy: 3 months at least 4. Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose. 5. ECOG Performance Status of 0,1, or 2 6. Age: At least 18 years old. CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows: 7. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 8. Platelets ≥ 100,000 cells/mm3; 9. Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows: 10. Total bilirubin ≤ 1.5 x institution

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