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PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma

Neoadjuvant Sintilimab (PD-1 Antibody)-Chemotherapy and Concurrent Sintilimab-chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Phase 2 Clinical Trial

NCT03619824•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with histologically confirmed nasopharyngeal carcinoma.
•2. Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
•3. ECOG performance status ≤1.
•4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
•5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
•6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
•7. Patients must be informed of the investigational nature of this study and give written informed consent.
•8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

Exclusion Criteria

•1. Age \> 65 or \< 18.
•2. Hepatitis B surface antigen (HBsAg) positive and HBV DNA \>1×10e3 copies/ml
•3. Hepatitis C virus (HCV) antibody positive
•4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
•5. Has a known history of interstitial lung disease.
•6. Has any condition that required systemic corticosteroid (equivalent to prednisone \>10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
•7. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
•8. Is pregnant or breastfeeding.
•9. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
•10. Has known allergy to large molecule protein products or any compound of sintilimab.
+2 more criteria

Locations (1)

SUN YAT-SEN UNIVERSITY cANCER CENTER

Guangzhou, Guangdong, China

Key Dates

Start Date

January 1, 2019

Primary Completion Date

October 1, 2019

Completion Date

March 1, 2024

Last Updated

October 9, 2018

Enrollment

ESTIMATED participants

Conditions

Nasopharyngeal Neoplasms

Interventions

Sintilimab

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

intensity-modulated radiotherapy

RADIATION

Contacts

Jun Ma

CONTACT

+862087343469 majun2@mail.sysu.edu.cn

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma

Inclusion Criteria

Exclusion Criteria

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