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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT06592599
• Lead Sponsor: Stanford University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any<br> N OR any T, N1-3. No M1) per AJCC v 8<br><br> 2. Prior therapy: None for NPC permitted<br><br> 3. Life expectancy: 3 months at least<br><br> 4. Contraception requirements: Women of childbearing potential and male participants<br> who are sexually active must agree to use a medically effective means of birth<br> control during treatment with toripalimab and for 4 months after the last dose.<br><br> 5. ECOG Performance Status of 0,1, or 2<br><br> 6. Age: At least 18 years old.<br><br> CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate<br> bone marrow function defined as follows:<br><br> 7. Absolute neutrophil count (ANC) = 1,500 cells/mm3<br><br> 8. Platelets = 100,000 cells/mm3;<br><br> 9. Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to achieve<br> Hgb = 8.0 g/dl is acceptable.);<br><br> Adequate hepatic function within 21 days prior to day 1 of treatment, defined as<br> follows:<br><br> 10. Total bilirubin = 1.5 x institutional ULN;<br><br> 11. AST and ALT = 1.5 x institutional ULN;<br><br> Adequate renal function within 21 days prior to day 1 of treatment, defined as<br> follows:<br><br> 12. Serum creatinine = 1.5 mg/dl or calculated or measured creatinine clearance (CC) =<br> 50 ml/min<br><br> 13. Negative serum pregnancy test within 14 days prior to day 1 of treatment for women<br> of childbearing potential<br><br> 14. Ability to understand and the willingness to personally sign the written IRB<br> approved informed consent document.<br><br>Exclusion Criteria:<br><br> 1. Prior systemic anticancer treatment for NPC<br><br> 2. Prior radiation to head and neck region or regions necessitating overlapping fields<br><br> 3. Concurrent use of any anti- cancer treatment, standard, alternative or<br> investigational.<br><br> 4. History of allergic reactions to any agents in this study<br><br> 5. Autoimmune disease or organ transplant which in the judgment of the PI would<br> increase the risk of immune checkpoint inhibition.<br><br> 6. Pregnant or breastfeeding<br><br> 7. Severe, active co-morbidity, defined as follows:<br><br> - Major medical or psychiatric illness, which in the investigator's opinion would<br> interfere with the completion of therapy and follow up or with full<br> understanding of the risks and potential complications of the therapy;<br><br> - Unstable angina and/or uncontrolled congestive heart failure within past 6<br> months;<br><br> - Myocardial infarction within the last 6 months;<br><br> - Current acute bacterial or fungal infection requiring intravenous antibiotics;<br> note that patients receiving IV antibiotics or currently on oral antibiotics<br> whose infection is assessed to be adequately treated or controlled are<br> eligible.<br><br> - Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness<br> requiring hospitalization or precluding study therapy within 30 days prior to<br> day 1 of treatment;<br><br> 8. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note,<br> however, that HIV testing is not required for entry into this protocol. The need to<br> exclude patients with AIDS from this protocol is necessary because the treatments<br> involved in this protocol may be significantly immunosuppressive<br><br> 9. Patients with hearing loss assessed to be primarily sensorineural in nature,<br> requiring a hearing aid, or intervention (i.e. interfering in a clinically<br> significant way with activities of daily living); a conductive hearing loss that is<br> tumor-related is allowed<br><br> 10. = grade 2 peripheral sensory neuropathy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Induction chemotherapy completion rate;Radiation completion rate

Secondary Outcome Measures

Name	Time	Method
Overall Response (ORD) rate following induction;Complete Response (CR) rate following radiation