PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

March 14, 2024 updated by: Zhao Chong, Sun Yat-sen University

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

212

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
      • Beijing, China
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
          • Suqing Tian
      • Chengdu, China
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Shun Lu
      • Fuzhou, China
        • Not yet recruiting
        • Fujian Province Cancer Hospital
        • Contact:
          • Shaojun Lin
      • Guiyang, China
        • Recruiting
        • Guizhou Cancer Hospital
        • Contact:
          • Feng Jin
      • Hangzhou, China
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Xiaozhong Chen
      • Nanchang, China
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Jingao Li
      • Nanning, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Rengshen Wang
      • Shanghai, China
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Chaosu Hu
      • Wuhan, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Conghua Xie
      • Xi'an, China
        • Recruiting
        • Xijing Hospital
        • Contact:
          • Mei Shi
      • Xiamen, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Qin Lin
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
  • Not suitable for surgery;
  • Newly histologic diagnosis of NPC (WHO II/III);
  • Clinical stage rII-IVa (AJCC/UICC 8th);
  • ECOG 0-1 point;
  • No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
  • No contraindications to immunotherapy or radiotherapy;
  • Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
  • Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
  • Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
  • Take effective contraceptions during and two months after treatment;
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • Treated with anti-tumor Chinese medicine treatment;
  • Have recurrence with local necrosis;
  • Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
  • Unexplained fever > 38.5 ℃, except for tumor fever;
  • Treated with ≥ 5 days antibiotics one month before enrollment;
  • Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E4copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
  • Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
  • Have known allergy to large molecule protein products or any compound of study therapy;
  • Pregnant or breastfeeding;
  • Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
  • Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
  • Any other condition, including 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 antibody plus chemoradiotherapy
Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Drug: PD-1 blocking antibody
Toripalimab 240mg, D1, every 3 weeks per cycle
Other Names:
  • JS001
Drug: GP
Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
Radiation: IMRT
IMRT 60-66Gy, 1.8-2.0Gy/f/day
Active Comparator: Chemoradiotherapy
Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
Drug: GP
Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
Radiation: IMRT
IMRT 60-66Gy, 1.8-2.0Gy/f/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
From date of randomisation to death
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 3 years
From date of randomisation to disease progression
3 years
Short-term effects
Time Frame: through study completion, an average of 2 months
Patient's objective response rate
through study completion, an average of 2 months
Rate of patients with acute toxicities
Time Frame: through study completion, an average of 2 months
Evaluating with CTCAE v5.0
through study completion, an average of 2 months
Quality of life: EuroQoL 5 dimension
Time Frame: through whole study, an average of 3 years
Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)
through whole study, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Chong Zhao, 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.

Helpful Links

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)

March 1, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rNPC-JS001

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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