The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

August 29, 2025 updated by: Shanghai Junshi Bioscience Co., Ltd.

A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer

This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total 289 patients were enrolled and randomized in a 1:1 ratio to the group of JS001 (Arm A) with gemcitabine and cisplatin or placebo (Arm B) with gemcitabine and cisplatin every 3 weeks (Q3W) in the 'during chemotherapy' phase. During the 'post-chemotherapy' phase, patients randomized to Arm A or Arm B will continue treatment with JS001 or placebo as maintenance therapy Q3W until excessive toxicity or progressive disease, withdrawal of consent or Investigator's judgement or a maximum of 2 years. Tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. The primary objective is to compare PFS as assessed by the IRC in ITT population (all randomized patients).

Study Type

Interventional

Enrollment (Actual)

289

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 Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer hospital, Chinese Academy of Medical Sciences
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350000
        • Fujian Provincial Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital
      • Guangzhou, Guangdong, China, 510060
        • Sun yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510095
        • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
      • Shenzhen, Guangdong, China, 518020
        • ShenZhen People's Hospital
    • Guangxi
      • Liuzhou, Guangxi, China, 545000
        • Liuzhou Worker's Hospital
      • Nanning, Guangxi, China, 530021
        • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Guangzhou
      • Shantou, Guangzhou, China, 515031
        • Cancer Hospital of Shantou University Medical College
      • Zhanjiang, Guangzhou, China, 130012
        • Affiliated Hospital of Guangdong Medical University
      • Zhuhai, Guangzhou, China, 519000
        • The Fifth Affiliated Hospital Sun Yat-Sen University - Medical Oncology
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • The Affiliated Cancer Hospital of Guizhou Medical University
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital (Hainan Province People's Hospital)
    • Hebei
      • Shijiazhuang, Hebei, China, 50011
        • Hebei Oncology Hospital
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyTongji Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Oncology Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Shanghai General Hospital
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
  • Taiwan
      • Taichung, Taiwan, 404
        • China Medical University Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan City, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Age ≥ 18 years and ≤75 years.
  • 2. Histological/cytological confirmation of NPC.
  • 3. Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment.
  • 4. At least 1 measurable lesion according to RECIST version 1.1.
  • 5. Life expectancy ≥ 3 months

Exclusion Criteria:

  • 1. History of severe hypersensitivity reactions to other mAbs or any ingredient of JS001.
  • 2. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T lymphocyte associated protein 4 (CTLA4) receptor.
  • 3. Major surgical procedure other than for diagnosis of NPC within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study
  • 4. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients.
  • 5. Female patients who are at pregnancy or lactation.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo combine with chemotherapy
Gemcitabine 1000 mg/m² IV are given on Days 1 & 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
Drug: Placebos
placebo combine with chemotherapy
Experimental: TORIPALIMAB INJECTION(JS001 )combine with chemotherapy
Gemcitabine 1000 mg/m² IV are given on Days 1 & 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
Biological: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
Time Frame: up to 2 years

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients.

The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-assessed ORR According to RECIST v1.1
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Investigator-assessed DoR According to RECIST v1.1
Time Frame: From date of response until progressive disease. Up to 2 approximately years
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.
From date of response until progressive disease. Up to 2 approximately years
Investigator-assessed DCR According to RECIST v1.1
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Investigator-assessed PFS According to RECIST v1.1
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
IRC-assessed ORR According to RECIST v1.1
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H&N35
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
IRC-assessed DoR According to RECIST v1.1
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed duration of response (DoR) according to RECIST v1.1.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
IRC-assessed DCR According to RECIST v1.1
Time Frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by IRC-assessed disease control rate (DCR) according to RECIST v1.1.
From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
OS
Time Frame: The time frame of OS collected is upto about 48months.
Overall survival was defined as the time from randomization to death from any cause.
The time frame of OS collected is upto about 48months.
Investigator-assessed PFS Rate at 1 Year
Time Frame: up to approximately 1years
To evaluate the PFS rate at 1 year in each treatment arm by investigator
up to approximately 1years
OS Rate at 1 Year
Time Frame: Up to approximately 1 years
To evaluate the OS rate at 1 year in each treatment arm
Up to approximately 1 years
Number of Participants Experiencing an Adverse Event(AE)
Time Frame: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Incidence of adverse events(AE) as assessed by CTCAE version 5.0
From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Anti-drug Antibody(ADA)
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate the incidence of ADAs against JS001
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
PFS IRC-assessed Per irRECIST
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
ORR IRC-assessed Per irRECIST
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
DoR IRC-assessed Per irRECIST
Time Frame: From date of response until progressive disease. Up to 2 approximately years
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
From date of response until progressive disease. Up to 2 approximately years
DCR IRC-assessed Per irRECIST
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
Investigator-assessed PFS Rate at 2 Years
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate the PFS rate at 2 years in each treatment arm by investigator
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
OS Rate at 2 Years
Time Frame: Up to approximately 2 years
To evaluate the OS rate at 2 years in each treatment arm
Up to approximately 2 years
PFS Investigator-assessed Per irRECIST
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
ORR Investigator-assessed Per irRECIST
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
DoR Investigator-assessed Per irRECIST
Time Frame: From date of response until progressive disease. Up to 2 approximately years
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
From date of response until progressive disease. Up to 2 approximately years
DCR Investigator-assessed Per irRECIST
Time Frame: Up to approximately 42 months
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Up to approximately 42 months

Collaborators and Investigators

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

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Investigators

  • Principal Investigator: Ruihua Xu, Ph.D, 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.

General Publications

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)

October 18, 2018

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

November 18, 2022

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS001-015-III-NPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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