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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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
• Prior therapy: None for NPC permitted
• Life expectancy: 3 months at least
• 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.
• ECOG Performance Status of 0,1, or 2
• 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:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥ 100,000 cells/mm3;
• 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:
• Total bilirubin ≤ 1.5 x institutional ULN;
• AST and ALT ≤ 1.5 x institutional ULN;
• Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:
• Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
• Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
• Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

You cannot join if

• Prior systemic anticancer treatment for NPC
• Prior radiation to head and neck region or regions necessitating overlapping fields
• Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
• History of allergic reactions to any agents in this study
• Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
• Pregnant or breastfeeding
• Severe, active co-morbidity, defined as follows:
• Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
• Unstable angina and/or uncontrolled congestive heart failure within past 6 months;
• Myocardial infarction within the last 6 months;
• Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
• Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
• ≥ grade 2 peripheral sensory neuropathy

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

toripalimab-tpzi. A humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, toripalimab binds to PD-1 and inhibits the binding of PD-1 to its ligands, programmed cell death-1 ligand 1 (PD-L1) and PD-1 ligand 2 (PD-L2). This prevents the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of both T cells and T-cell-mediated immune responses against tumor cells. PD-1, a transmembrane protein in the Ig superfamily that is expressed on activated T cells, negatively regulates T-cell activation and effector function when activated by its ligands; it plays an important role in tumor evasion from host immunity. NCI Drug Dictionary

Treatments listed in the registry

• Toripalimab (Drug): Toripalimab will be administered 240 mg intravenously every three weeks in combination with the induction chemotherapy regimen for 3 cycles, and for 9 cycles as adjuvant treatment following radiation as specified in the overall sequential treatment plan.
• Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation (Radiation): Radiation treatment will be initiated 3-6 weeks following day 1 of the last induction cycle using institutional standards of care and support as follows: Intensity modulated radiotherapy, 70 Gy in 33 fractions M-F once daily plus cisplatin 40 mg/m2 IV weekly for up to 7 doses. Following the completion of concurrent chemoradiation, capecitabine will be administered using institutional standards of care as follows: Capecitabine 650 mg/m2 PO BID x 12 months beginning 12 to 16 weeks following the end of radiation treatment. Dose reductions and discontinuance of capecitabine will be according to the standard of care applied at the treating institution. Adjuvant Toripalimab 240 mg IV q 21d x 9 maximum doses will be initiated concurrently with the initiation of adjuvant capecitabine, beginning 12-16 weeks following the end of radiation.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• radiation: Part of the study plan

Main goals

• Induction chemotherapy completion rate (3 years)
• Radiation completion rate (3 years)

Other goals

• Overall Response (ORD) rate following induction
• Complete Response (CR) rate following radiation

Planned enrollment: 24 (estimated).

• Stanford University, Palo Alto, California

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06592599
• NCI Drug Dictionary: C131334

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 22, 2026. Public record; not medical advice.