Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study

To explore the progression-free survival rate (progression-free survival, PFS), overall survival (OS), objective response rate(objective response rate, ORR) and safety of patients with Sintilimab + GP chemotherapy combined with radiotherapy for newly diagnosed metastatic NPC.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Other: Immunotherapy+induction chemotherapy+radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathologically diagnosed nasopharyngeal cancer with distant metastasis; not received anticancer treatment.
• ECOG Score (PS score) 0 or 1.
• Neutrophil count > 1.5*10^9/L, hemoglobin > 90g/L, and platelet count > 100*10^9/L.
• ALT or AST level < 2.5 times upper normal limit (upper limit of normal, ULN), bilirubin level < 1.5 times ULN.
• Creatinine clearance level > 60 ml/min.
• Patients must sign an informed consent and must be willing and able to comply with the visit, treatment protocol, laboratory tests and other requirements specified in the study protocol.
• Pregnant female subjects must agree to use reliable contraception within 1 year from the screening visit to the last Sintilimab administration.

Exclusion Criteria:

• Age> 65 years old or <18 years old.
• HBsAg positive and HBV DNA> 10*10^3 copy number/ml.
• HCV antibody positive.
• Active, known, or suspected autoimmune diseases. Subjects with type I diabetes, hypothyroidism with only hormone replacement therapy, and skin disease without systemic treatment (such as vitiligo, psoriasis, or alopecia) can be selected.
• A history of interstitial lung disease.
• Received systemic hormone or other immunosuppressive therapy with an equivalent dose of> 10mg of prednisone per day within 28 days prior to signing the informed consent. Subjects with a systemic hormone dose of 10mg prednisone per day or inhaled / topical corticosteroids may be enrolled.
• Received or will be vaccinated within 30 days before signing the informed consent.
• Pregnancy or breastfeeding women (pregnancy tests should be considered).
• Other malignancies within 5 years, except carcinoma in situ, fully treated non-melanoma skin cancer, and papillary thyroid carcinoma.
• previous allergies to macromolecular protein preparations, or any component of Sintilimab.
• Human immunodeficiency virus (HIV) infection.
• Other conditions that may affect the safety or trial compliance of the subject, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic treatment, mental illness or family and social factors.

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: Immunotherapy+induction chemotherapy+radiotherapy

Other: Immunotherapy+induction chemotherapy+radiotherapy; All enrolled patients received Sintilimab (200mg, d1, q3w) + GP (gemcitabine 1000mg / m2, d1, d8 + cisplatin 80mg / m2, d1, q3w) for 4-6 cycles followed by radiotherapy of primary site and cervical metastasis, and Sintilimab (200mg, q3w) treatment was continued during and after radiotherapy until disease progression or toxicity or up to 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	from enrollment of treatment to the first disease progression, death, or the last follow-up	1-year PFS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	from enrollment treatment to death of any cause, if not, to last follow-up	1-year OS

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; First People's Hospital of Foshan; Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: B2021-382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No