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

A Safety, Feasibility and Efficacy Study of Gemcitabine Plus Docetaxel Plus Toripalimab (GDT) Induction as Part of a Curative Sequential Chemoradiation for Patients With Locoregional EBV Associated Nasopharyngeal Carcinoma (NPC)

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

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Toripalimab; Radiation: Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Elizabeth Winters; Phone Number: (650) 723-6372; Email: ewinters@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Principal Investigator: A. Dimitrios Colevas, MD
      • Contact: Elizabeth Winters; Phone Number: 650-723-6372; Email: ewinters@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 institutional ULN;

11. AST and ALT ≤ 1.5 x institutional ULN;

    Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:

12. Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
13. Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
14. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Exclusion Criteria:

1. Prior systemic anticancer treatment for NPC
2. Prior radiation to head and neck region or regions necessitating overlapping fields
3. Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
4. History of allergic reactions to any agents in this study
5. Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
6. Pregnant or breastfeeding

7. 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;
8. 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
9. 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
10. ≥ grade 2 peripheral sensory neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Gemcitabine, Docetaxel and Capecitabine; Patients will receive three q 21-day cycles of gemcitabine 1000 mg/m2 plus docetaxel 75 mg/m2 plus toripalimab 240 mg, followed by radiation to 70 Gy plus concurrent weekly cisplatin, 40 mg/m2 up to 7 doses, followed by adjuvant capecitabine 650 mg/m2 BID for one year plus toripalimab 240 mg q 21 days for 9 doses.

Drug: Toripalimab; 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.; Radiation: Concurrent Chemoradiation and Adjuvant treatment following Chemoradiation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction chemotherapy completion rate	Induction chemotherapy completion rate, defined as the proportion of patients who complete three cycles of chemoimmunotherapy within 12 weeks of initiation. Completion is defined for induction as receiving all 3 cycles as planned, including protocol specified dose reduction and delays. .	3 years
Radiation completion rate	Radiation completion rate, defined as the proportion of patients who complete specified radiation within 8 weeks of radiation initiation. Radiation completion is defined as completion of planned doses of radiation.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response (ORD) rate following induction	OR rate following induction, defined as the proportion of patients who achieve at least a RECIST defined PR within 12 weeks of induction chemotherapy initiation.	3 years
Complete Response (CR) rate following radiation	CR rate following radiation, defined as the proportion of patients who achieve a RECIST defined CR within 16 weeks following the end of radiation therapy.	3 years

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: A. Dimitrios Colevas, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: toripalimab; gemcitabine; docetaxel
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; toripalimab
• Other Study ID Numbers: IRB-75587; NCI-2025-00939 (Registry Identifier: National Cancer Institute Clinical Trials Reporting Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes