- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557020
Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC
April 19, 2024 updated by: Jiangxi Provincial Cancer Hospital
Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma
This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Phase 3
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: Jingao Li
- Phone Number: 86-791-88300252
- Email: lijingao@hotmail.com
Study Contact Backup
- Name: Tianzhu Lu, PhD
- Phone Number: 15270186250
- Email: lutianzhu2008@163.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350014
- Recruiting
- Fujian cancer hospital
-
Contact:
- Shaojun Lin, MD
- Email: linshaojun@yeah.net
-
Principal Investigator:
- Shaojun Lin, MD
-
-
Jiangxi
-
Ganzhou, Jiangxi, China, 341000
- Recruiting
- Ganzhou Cancer Hospital
-
Contact:
- Wei Wu, M.D.
-
Principal Investigator:
- Wei Wu, M.D.
-
Guangzhou, Jiangxi, China, 341000
- Recruiting
- First Affiliated Hospital of Gannan Medical University
-
Contact:
- Mingjun Xu, MD
-
Principal Investigator:
- Mingjun Xu, MD
-
Nanchang, Jiangxi, China, 330006
- Not yet recruiting
- The First Affiliated Hospital of NanChang University
-
Contact:
- Xiaojun Zhong, M.D., Ph.D
-
Principal Investigator:
- Xiaojun Zhong, M.D. Ph.D
-
Nanchang, Jiangxi, China, 330006
- Not yet recruiting
- The Second Affiliated Hospital of Nanchang University
-
Contact:
- Jianwu Ding, M.D
-
Principal Investigator:
- Jianwu Ding, M.D
-
Nanchang, Jiangxi, China, 330029
- Recruiting
- Jiangxi Cancer Hospital
-
Contact:
- Xiaochang Gong, MD
- Phone Number: 13970020755
- Email: gxcanddw@163.com
-
Principal Investigator:
- Xiaochang Gong, MD
-
Shangrao, Jiangxi, China, 334120
- Not yet recruiting
- Shangrao People's Hospital
-
Contact:
- Kairong Huang, M.D.
-
Principal Investigator:
- Kairong Huang, M.D.
-
-
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 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
- Clinical staged as T4 or N3 (according to the 8th AJCC edition)
- No evidence of distant metastasis (M0)
- Male and no pregnant female
- ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
- Normal renal function test ( creatinine clearance ≥60 ml/min)
Exclusion Criteria:
- Recurrent or distant metastatic disease.
- History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
- History of radiotherapy or chemotherapy.
- History of immunodeficiency disease
- History of organ transplantation
- Presence of life-threatening illness
- Uncontrolled hypercalcemia
- Severe uncontrolled medical conditions or active infectious diseases
- Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
- Pregnant or breastfeeding female
- Emotional disturbance or mental illness
- Refusal or inability to sign informed consent
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
IC with anti-PD1 mab+CCRT+anti-PD1 mab
|
neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles.
Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT
|
Active Comparator: Arm B
IC+CCRT
|
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles.
Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progress-free survival (PFS)
Time Frame: 3 year
|
From date of randomization to date of first documentation of progression or death due to any cause.
|
3 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 3 year
|
From date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
|
3 year
|
Distant Metastasis-Free Survival (DMFS)
Time Frame: 3 year
|
From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit.
|
3 year
|
Locoregional Relapse-Free Survival (LRRFS)
Time Frame: 3 year
|
From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
|
3 year
|
Objective Response Rate (ORR)
Time Frame: within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
|
Either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
|
within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
|
adverse events (AEs)
Time Frame: 3 year
|
Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jingao Li, M.D., Jiangxi Cancer Hospital of Nanchang University
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 (Actual)
December 30, 2020
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
September 18, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
February 1, 2024
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
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Antibodies
- Gemcitabine
Other Study ID Numbers
- NPC2020-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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