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

NCT05417139 | Unknown Phase 2 DMC

• 1 other identifier: B2021-382
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  from enrollment of treatment to the first disease progression, death, or the last follow-up

  1-year PFS

Secondary Outcomes (1)

• OS

  1-year OS

Study Arms (1)

Immunotherapy+induction chemotherapy+radiotherapy

EXPERIMENTAL

Other: Immunotherapy+induction chemotherapy+radiotherapy

Interventions

Immunotherapy+induction chemotherapy+radiotherapy OTHER

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.

Immunotherapy+induction chemotherapy+radiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 14, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

CN (1)