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

Primary Purpose

Recurrent or Metastatic NPC

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Placebos
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Metastatic NPC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences
  • Fujian Medical University Union Hospital
  • Fujian Provincial Cancer Hospital
  • Sun Yat-Sen University Cancer Center
  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Nanfang Hospital
  • Shenzhen People's Hospital
  • Liuzhou Worker's Hospital
  • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Cancer Hospital of Shantou University Medical College
  • Affiliated Hospital of Guangdong Medical University
  • The Fifth Affiliated Hospital Sun Yat-Sen University - Medical Oncology
  • Guizhou Cancer Hospital_Affiliated Hospital of Guizhou Medical University
  • Hainan General Hospital (Hainan Province People's Hospital)
  • Hebei Oncology Hospital
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyTongji Hospital
  • The Second Xiangya Hospital of Central South University
  • Hunan Cancer Hospital
  • Jiangsu Oncology Hospital
  • Jiangxi Cancer Hospital
  • Fudan University Cancer Hospital
  • Shanghai first people's hospital
  • West China Hospital, Sichuan University
  • Zhejiang Cancer Hospital
  • National Cancer Centre
  • Tan Tock Seng Hospital
  • China Medical University Hospital
  • TaiChung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo combine with chemotherapy

TORIPALIMAB INJECTION(JS001 )combine with chemotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
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 (thisincludes the baseline sum if that is the smallest on study). In addition to the relative increase of20%, 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.

Secondary Outcome Measures

OS
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by overall survival (OS). an AnticipatedReporting Date of final OS in 2023.
Investigator-assessed ORR According to RECIST v1.1
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.
Investigator-assessed DoR According to RECIST v1.1
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.
Investigator-assessed DCR According to RECIST v1.1
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.
Investigator-assessed PFS According to RECIST v1.1
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
Investigator-assessed PFS Rate at 1 and 2 Years
To evaluate the PFS rate at 1 and 2 years in each treatment arm by investigator
OS Rate at 1 and 2 Years
To evaluate the OS rate at 1 and 2 years in each treatment arm
Patient-Reported Outcome (PRO) Using EORTC QLQ-C30, EORTC QLQ-H&N35 and ECOG Performance Status Assessments
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-C30 &EORTC QLQ-H&N35ECOG
IRC-assessed ORR According to RECIST v1.1
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H&N35
IRC-assessed DoR According to RECIST v1.1
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.
IRC-assessed DCR According to RECIST v1.1
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.
Safety Variables Will be Monitored and Reported:AE.SAE.Vital Signs,Physical Examinations,Laboratory Variable,ECG
Incidence of serious adverse events(SAE) as assessed by CTCAE version 5.0
ADAs
To evaluate the incidence and titers of ADAs against JS001 and to explore the potential relationship of the immunogenicity response with pharmacodynamics, safety and efficacy.
PFS Assessed Per irRECIST
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
ORR Assessed Per irRECIST
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
DoR Assessed Per irRECIST
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
DCR Assessed Per irRECIST
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Full Information

First Posted
June 5, 2018
Last Updated
April 15, 2022
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03581786
Brief Title
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic NPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
289 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo combine with chemotherapy
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
TORIPALIMAB INJECTION(JS001 )combine with chemotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Intervention Description
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
placebo combine with chemotherapy
Primary Outcome Measure Information:
Title
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
Description
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 (thisincludes the baseline sum if that is the smallest on study). In addition to the relative increase of20%, 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.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
OS
Description
To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by overall survival (OS). an AnticipatedReporting Date of final OS in 2023.
Time Frame
up to 5 years
Title
Investigator-assessed ORR According to RECIST v1.1
Description
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.
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
Title
Investigator-assessed DoR According to RECIST v1.1
Description
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.
Time Frame
From date of response until progressive disease. Up to 2 approximately years
Title
Investigator-assessed DCR According to RECIST v1.1
Description
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.
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
Title
Investigator-assessed PFS According to RECIST v1.1
Description
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-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
Title
Investigator-assessed PFS Rate at 1 and 2 Years
Description
To evaluate the PFS rate at 1 and 2 years in each treatment arm by investigator
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
Title
OS Rate at 1 and 2 Years
Description
To evaluate the OS rate at 1 and 2 years in each treatment arm
Time Frame
From date of randomization until death, loss to follow-up, or study termination by the Sponsor whichever occurs first.Up to 3.5 approximately years
Title
Patient-Reported Outcome (PRO) Using EORTC QLQ-C30, EORTC QLQ-H&N35 and ECOG Performance Status Assessments
Description
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-C30 &EORTC QLQ-H&N35ECOG
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
Title
IRC-assessed ORR According to RECIST v1.1
Description
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H&N35
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
Title
IRC-assessed DoR According to RECIST v1.1
Description
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.
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
Title
IRC-assessed DCR According to RECIST v1.1
Description
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.
Time Frame
From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Title
Safety Variables Will be Monitored and Reported:AE.SAE.Vital Signs,Physical Examinations,Laboratory Variable,ECG
Description
Incidence of serious adverse events(SAE) as assessed by CTCAE version 5.0
Time Frame
From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Title
ADAs
Description
To evaluate the incidence and titers of ADAs against JS001 and to explore the potential relationship of the immunogenicity response with pharmacodynamics, safety and efficacy.
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
Title
PFS Assessed Per irRECIST
Description
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to 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
Title
ORR Assessed Per irRECIST
Description
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to 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
Title
DoR Assessed Per irRECIST
Description
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Time Frame
From date of response until progressive disease. Up to 2 approximately years
Title
DCR Assessed Per irRECIST
Description
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruihua Xu, Ph.D
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Liuzhou Worker's Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545000
Country
China
Facility Name
The People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangzhou
ZIP/Postal Code
515031
Country
China
Facility Name
Affiliated Hospital of Guangdong Medical University
City
Zhanjiang
State/Province
Guangzhou
ZIP/Postal Code
130012
Country
China
Facility Name
The Fifth Affiliated Hospital Sun Yat-Sen University - Medical Oncology
City
Zhuhai
State/Province
Guangzhou
ZIP/Postal Code
519000
Country
China
Facility Name
Guizhou Cancer Hospital_Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Name
Hainan General Hospital (Hainan Province People's Hospital)
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Hebei Oncology Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50011
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyTongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Jiangsu Oncology Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai first people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Facility Name
TaiChung Veterans General Hospital
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
34341578
Citation
Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. doi: 10.1038/s41591-021-01444-0. Epub 2021 Aug 2. Erratum In: Nat Med. 2022 Jan;28(1):214.
Results Reference
derived

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

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