Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

April 30, 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

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Shaojun Lin, MD
    • Hubei
      • Suizhou, Hubei, China
        • Recruiting
        • Suizhou Central Hospital
        • Sub-Investigator:
          • Dongsheng Zhang
        • Contact:
          • Dongsheng Zhang, 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
        • Contact:
          • Renwang Chen
      • Jiujiang, Jiangxi, China, 332000
        • Recruiting
        • Jiujiang University Affiliated Hospital
        • Contact:
          • Zhaohui Leng, MD
        • Sub-Investigator:
          • Zhaohui Leng, MD
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xiaochang Gong, MD
      • Pingxiang, Jiangxi, China, 330029
        • Recruiting
        • Pingxiang Peoples' Hospital
        • Contact:
          • Fan Cai, MD
        • Sub-Investigator:
          • Fan Cai

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:

  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

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
Drug: PD-1 antibody
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
Drug: Gemcitabine
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
Radiation: IMRT
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
Drug: Cisplatin
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
Drug: Gemcitabine
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
Radiation: IMRT
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
Drug: Cisplatin
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.

Sponsor

Jiangxi Provincial Cancer Hospital

Investigators

  • Principal Investigator: Jingao Li, M.D., Jiangxi Provincial Cancer Hospital

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)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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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