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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Immunotherapy+induction chemotherapy+radiotherapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunotherapy+induction chemotherapy+radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

OS
from enrollment treatment to death of any cause, if not, to last follow-up

Full Information

First Posted
June 7, 2022
Last Updated
June 9, 2022
Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First People's Hospital of Foshan
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1. Study Identification

Unique Protocol Identification Number
NCT05417139
Brief Title
Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study
Official Title
Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, First People's Hospital of Foshan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immunotherapy+induction chemotherapy+radiotherapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Immunotherapy+induction chemotherapy+radiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
PFS
Description
from enrollment of treatment to the first disease progression, death, or the last follow-up
Time Frame
1-year PFS
Secondary Outcome Measure Information:
Title
OS
Description
from enrollment treatment to death of any cause, if not, to last follow-up
Time Frame
1-year OS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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