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Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
PD-1 antibody
Gemcitabine
Cisplatin
IMRT
Sponsored by
Jiangxi Provincial Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
  2. Clinical staged as T4 or N3 （according to the 8th AJCC edition）
  3. No evidence of distant metastasis (M0)
  4. Male and no pregnant female
  5. ECOG (Eastern Cooperative OncologyGroup) scale 0-1
  6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
  7. Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
  8. Normal renal function test ( creatinine clearance ≥60 ml/min)

Exclusion Criteria:

  1. Recurrent or distant metastatic disease.
  2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
  3. History of radiotherapy or chemotherapy.
  4. History of immunodeficiency disease
  5. History of organ transplantation
  6. Presence of life-threatening illness
  7. Uncontrolled hypercalcemia
  8. Severe uncontrolled medical conditions or active infectious diseases
  9. Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
  10. Pregnant or breastfeeding female
  11. Emotional disturbance or mental illness
  12. Refusal or inability to sign informed consent

Sites / Locations

  • Ganzhou Cancer HospitalRecruiting
  • The First Affiliated Hospital of Nanchang University
  • The Second Affiliated Hospital of Nanchang University
  • Shangrao People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

IC with anti-PD1 mab+CCRT+anti-PD1 mab

IC+CCRT

Outcomes

Primary Outcome Measures

Progress-free survival (PFS)
From date of randomization to date of first documentation of progression or death due to any cause.

Secondary Outcome Measures

Overall Survival (OS)
From date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Distant Metastasis-Free Survival (DMFS)
From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit.
Locoregional Relapse-Free Survival (LRRFS)
From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
Objective Response Rate （ORR）
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).
adverse events (AEs)
Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0

Full Information

First Posted
September 2, 2020
Last Updated
July 20, 2023
Sponsor
Jiangxi Provincial Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04557020
Brief Title
Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC
Official Title
Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Provincial Cancer Hospital

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
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

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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
IC with anti-PD1 mab+CCRT+anti-PD1 mab
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
IC+CCRT
Intervention Type
Drug
Intervention Name(s)
PD-1 antibody
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
IMRT
Intervention Description
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
Primary Outcome Measure Information:
Title
Progress-free survival (PFS)
Description
From date of randomization to date of first documentation of progression or death due to any cause.
Time Frame
3 year
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
From date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time Frame
3 year
Title
Distant Metastasis-Free Survival (DMFS)
Description
From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit.
Time Frame
3 year
Title
Locoregional Relapse-Free Survival (LRRFS)
Description
From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
Time Frame
3 year
Title
Objective Response Rate （ORR）
Description
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).
Time Frame
within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
Title
adverse events (AEs)
Description
Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingao Li
Phone
86-791-88300252
Email
lijingao@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingao Li, M.D.
Organizational Affiliation
Jiangxi Cancer Hospital of Nanchang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ganzhou Cancer Hospital
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wu, M.D.
First Name & Middle Initial & Last Name & Degree
Wei Wu, M.D.
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Zhong, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Xiaojun Zhong, M.D. Ph.D
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianwu Ding, M.D
First Name & Middle Initial & Last Name & Degree
Jianwu Ding, M.D
Facility Name
Shangrao People's Hospital
City
Shangrao
State/Province
Jiangxi
ZIP/Postal Code
334120
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kairong Huang, M.D.
First Name & Middle Initial & Last Name & Degree
Kairong Huang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

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