- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619824
PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma
October 6, 2018 updated by: Jun Ma, MD, Sun Yat-sen University
Neoadjuvant Sintilimab (PD-1 Antibody)-Chemotherapy and Concurrent Sintilimab-chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma: a Single-arm, Phase 2 Clinical Trial
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Ma
- Phone Number: +862087343469
- Email: majun2@mail.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat-Sen University Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- Patients with histologically confirmed nasopharyngeal carcinoma.
- Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
- ECOG performance status ≤1.
- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
- Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
- Patients must be informed of the investigational nature of this study and give written informed consent.
- 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:
- Age > 65 or < 18.
- Hepatitis B surface antigen (HBsAg) positive and HBV DNA >1×10e3 copies/ml
- Hepatitis C virus (HCV) antibody positive
- 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).
- Has a known history of interstitial lung disease.
- 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.
- Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
- Is pregnant or breastfeeding.
- Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
- Has known allergy to large molecule protein products or any compound of sintilimab.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention arm
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation.
Definitive intensity-modulated radiotherapy (IMRT) of 66-70Gy will be given in six to seven weeks.
Concurrent cisplatin 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.
Sintilimab 200mg will be given every 3 weeks for 6 cycles, started on day 1 of induction chemotherapy.
|
Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Sintilimab 200mg ivdrip, every 3 weeks for 6 cycles
Other Names:
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Other Names:
Definitive IMRT of 66-70Gy will be given in six to seven weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune-related adverse events (irAEs) and serious adverse events (irSAEs)
Time Frame: From the date of informed consent to 100 days after treatment
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Graded according to CTCAE V5.0
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From the date of informed consent to 100 days after treatment
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All adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From the date of informed consent to 100 days after treatment
|
Graded according to CTCAE V5.0
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From the date of informed consent to 100 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of patients who completed radiation within 8 weeks
Time Frame: 8 weeks
|
8 weeks
|
|
The proportion of patients who completed 6 cycles of sintilimab
Time Frame: From the date of informed consent to the end of treatment, assessed up to 20 weeks.
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From the date of informed consent to the end of treatment, assessed up to 20 weeks.
|
|
Failure-free survival
Time Frame: 3 years
|
calculated from the date of informed consent to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.
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3 years
|
Overall survival
Time Frame: 3 years
|
calculated from the date of informed consent to the date of death from any cause.
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3 years
|
Distant failure-free survival
Time Frame: 3 years
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calculated from the date of informed consent to the date of distant metastasis.
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3 years
|
Locoregional failure-free survival
Time Frame: 3 years
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calculated from the date of informed consent to the the date of locoregional persistence or 1st locoregional recurrence.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jun Ma, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2019
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
July 30, 2018
First Submitted That Met QC Criteria
August 2, 2018
First Posted (Actual)
August 8, 2018
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 6, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- B2018-090-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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