Recurrent or Metastatic NPCPhase 3NCT03581786
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
A Phase 3 study testing TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy in people with Recurrent or Metastatic NPC, run by Shanghai Junshi Bioscience Co., Ltd. at 32 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent or Metastatic NPC
- What is being tested?
- TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 32 sitesin 3 countries
- Study dates
- 18 Oct 2018to 18 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
China25 sites
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Hunan Cancer Hospital
Changsha, Hunan, 410013
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510095
Nanfang Hospital
Guangzhou, Guangdong, 510515
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Hainan General Hospital (Hainan Province People's Hospital)
Haikou, Hainan, 570311
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Liuzhou Worker's Hospital
Liuzhou, Guangxi, 545000
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Jiangsu Oncology Hospital
Nanjing, Jiangsu, 210000
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Cancer Hospital of Shantou University Medical College
Shantou, Guangzhou, 515031
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Hebei Oncology Hospital
Shijiazhuang, Hebei, 50011
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430023
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyTongji Hospital
Wuhan, Hubei, 430030
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangzhou, 130012
The Fifth Affiliated Hospital Sun Yat-Sen University - Medical Oncology
Zhuhai, Guangzhou, 519000
Taiwan5 sites
China Medical University Hospital
Taichung, 404
TaiChung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital
Tainan, 704
Taipei Veterans General Hospital
Taipei, 112
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan, 333
Singapore2 sites
National Cancer Centre
Singapore, 169610
Tan Tock Seng Hospital
Singapore, 308433
About this study
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
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.
Read the 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).
- Conditions
- Recurrent or Metastatic NPC
- Being tested
- TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy, Placebos
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapyBiological
TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
PlacebosDrug
placebo combine with chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| placebo combine with chemotherapy | Placebo comparator | 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 Receives: Drug: Placebos |
| TORIPALIMAB INJECTION(JS001 )combine with chemotherapy | Experimental | 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 Receives: Biological: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (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.
Measured: up to 2 years
Secondary outcomes (22)
OS
Overall survival was defined as the time from randomization to death from any cause.
Measured: The time frame of OS collected is upto about 48months.
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.
Measured: 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
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.
Measured: From date of response until progressive disease. Up to 2 approximately years
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.
Measured: 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
To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
Measured: 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 1 Year
To evaluate the PFS rate at 1 year in each treatment arm by investigator
Measured: up to approximately 1years
OS Rate at 1 Year
To evaluate the OS rate at 1 year in each treatment arm
Measured: Up to approximately 1 years
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
Measured: 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
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.
Measured: 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
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.
Measured: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Number of Participants Experiencing an Adverse Event(AE)
Incidence of adverse events(AE) as assessed by CTCAE version 5.0
Measured: From date of consent informed until 60 days after the last investigational product administration. Up to 2 approximately years
Anti-drug Antibody(ADA)
To evaluate the incidence of ADAs against JS001
Measured: 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
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: 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
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: 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
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: From date of response until progressive disease. Up to 2 approximately years
DCR IRC-assessed Per irRECIST
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: 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
To evaluate the PFS rate at 2 years in each treatment arm by investigator
Measured: 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
To evaluate the OS rate at 2 years in each treatment arm
Measured: Up to approximately 2 years
PFS Investigator-assessed Per irRECIST
To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: 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
To evaluate ORR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: 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
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: From date of response until progressive disease. Up to 2 approximately years
DCR Investigator-assessed Per irRECIST
To evaluate DCR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
Measured: Up to approximately 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start18 Oct 2018
- Primary completion30 May 2020
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent or Metastatic NPCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581786
- Sponsor's protocol ID
- JS001-015-III-NPC
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2018
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, 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, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.
PubMed 38015220Mai 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.
PubMed 34341578
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03581786
- Acronym / sponsor ID
- JS001-015-III-NPC
- Conditions
- Recurrent or Metastatic NPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Posted 18 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo combine with chemotherapy | Placebo comparator | Drug: PlacebosGemcitabine 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 |
| TORIPALIMAB INJECTION(JS001 )combine with chemotherapy | Experimental | Biological: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapyGemcitabine 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORIPALIMAB INJECTION(JS001 ) combine with chemotherapyTORIPALIMAB INJECTION(JS001 ) combine with chemotherapy | Biological | TORIPALIMAB INJECTION(JS001 )combine with chemotherapy |
| Placebosplacebo combine with chemotherapy | Drug | placebo combine with chemotherapy |
Primary outcome
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.
22 secondary outcomes
OS
Time frame: The time frame of OS collected is upto about 48months.
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
Investigator-assessed DoR According to RECIST v1.1
Time frame: 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
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
Investigator-assessed PFS Rate at 1 Year
Time frame: up to approximately 1years
OS Rate at 1 Year
Time frame: Up to approximately 1 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
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
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
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
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
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
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
DoR IRC-assessed Per irRECIST
Time frame: 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
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
OS Rate at 2 Years
Time frame: 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
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
DoR Investigator-assessed Per irRECIST
Time frame: From date of response until progressive disease. Up to 2 approximately years
DCR Investigator-assessed Per irRECIST
Time frame: Up to approximately 42 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38015220Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, 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, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.
- Derived from this study: PubMed 34341578Mai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruihua Xu, Ph.D principal investigator
Sun Yat-sen University
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy in people with Recurrent or Metastatic NPC, run by Shanghai Junshi Bioscience Co., Ltd. at 32 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China, Taiwan, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03581786, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.