Trial · NCT03581786

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

NCT03581786, Phase 3, Completed, Shanghai Junshi Bioscience Co., Ltd.; results first posted 2022-04-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer. Trials, record NCT03581786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03581786

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
NCT number: NCT03581786
Status: Completed
Phases: Phase 3
Enrollment: 289 participants, actual
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Conditions: Recurrent or Metastatic NPC
Interventions: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy, Placebos
First posted: 2018-07-10
Last updated: 2025-09-02
Results first posted: 2022-04-18

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1	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.
Secondary	OS	The time frame of OS collected is upto about 48months.	Overall survival was defined as the time from randomization to death from any cause.
Secondary	Investigator-assessed 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	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.
Secondary	Investigator-assessed DoR According to RECIST v1.1	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.
Secondary	Investigator-assessed 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	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.
Secondary	Investigator-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	To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
Secondary	Investigator-assessed PFS Rate at 1 Year	up to approximately 1years	To evaluate the PFS rate at 1 year in each treatment arm by investigator
Secondary	OS Rate at 1 Year	Up to approximately 1 years	To evaluate the OS rate at 1 year in each treatment arm
Secondary	IRC-assessed 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	health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35
Secondary	IRC-assessed 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	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.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1	up to 2 years		months	MEDIAN
SECONDARY	OS	The time frame of OS collected is upto about 48months.	NE below means not estimable.	months	MEDIAN
SECONDARY	Investigator-assessed 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		Percentage of Participants	NUMBER
SECONDARY	Investigator-assessed DoR According to RECIST v1.1	From date of response until progressive disease. Up to 2 approximately years		months	MEDIAN
SECONDARY	Investigator-assessed 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		Percentage of Participants	NUMBER
SECONDARY	Investigator-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		months	MEDIAN
SECONDARY	Investigator-assessed PFS Rate at 1 Year	up to approximately 1years		Percentage of Participants	NUMBER
SECONDARY	OS Rate at 1 Year	Up to approximately 1 years		Percentage of Participants	NUMBER
SECONDARY	IRC-assessed 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		Percentage of Participants	NUMBER
SECONDARY	IRC-assessed 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		months	MEDIAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1	Placebo Combine With Chemotherapy	8.2	95% Confidence Interval 7.03 to 9.79	months
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	21.4	95% Confidence Interval 11.73 to NA	months
OS	Placebo Combine With Chemotherapy	33.7	95% Confidence Interval 27.01 to 44.19	months
OS	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	NA	95% Confidence Interval 38.70 to NA	months
Investigator-assessed ORR According to RECIST v1.1	Placebo Combine With Chemotherapy	75.5	95% Confidence Interval 67.64 to 82.32	Percentage of Participants
Investigator-assessed ORR According to RECIST v1.1	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	82.2	95% Confidence Interval 75.01 to 88.02	Percentage of Participants
Investigator-assessed DoR According to RECIST v1.1	Placebo Combine With Chemotherapy	6.0	95% Confidence Interval 5.75 to 7.16	months
Investigator-assessed DoR According to RECIST v1.1	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	16.0	95% Confidence Interval 11.93 to 22.47	months
Investigator-assessed DCR According to RECIST v1.1	Placebo Combine With Chemotherapy	90.9	95% Confidence Interval 84.96 to 95.07	Percentage of Participants
Investigator-assessed DCR According to RECIST v1.1	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	91.1	95% Confidence Interval 85.26 to 95.17	Percentage of Participants

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Combine With Chemotherapy	143
Overall Study	STARTED	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	146
Overall Study	COMPLETED	Placebo Combine With Chemotherapy	67
Overall Study	COMPLETED	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	89
Overall Study	NOT COMPLETED	Placebo Combine With Chemotherapy	76
Overall Study	NOT COMPLETED	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	57

Source ClinicalTrials.gov

Adverse events76

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	Placebo Combine With Chemotherapy	142	143
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	143	146
other	Gastrointestinal disorders	Gastrointestinal disorders	Placebo Combine With Chemotherapy	138	143
other	Gastrointestinal disorders	Gastrointestinal disorders	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	135	146
other	Metabolism and nutrition disorders	Metabolism and nutrition disorders	Placebo Combine With Chemotherapy	118	143
other	Metabolism and nutrition disorders	Metabolism and nutrition disorders	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	116	146
other	Investigations	Investigations	Placebo Combine With Chemotherapy	91	143
other	Investigations	Investigations	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	88	146
other	General disorders and administration site conditions	General disorders	Placebo Combine With Chemotherapy	91	143
other	General disorders and administration site conditions	General disorders	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	89	146

1 to 10 of 76Source ClinicalTrials.gov

See all 76 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Combine With Chemotherapy	67	143
Total, all-cause mortality	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	47	146
Total, other adverse events	Placebo Combine With Chemotherapy	143	143
Total, other adverse events	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	146	146
Total, serious adverse events	Placebo Combine With Chemotherapy	62	143
Total, serious adverse events	TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy	64	146

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34341578	DERIVED	PubMed
38015220	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Placebo Combine With Chemotherapy vs TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy: Number of Participants Experiencing an Adverse Event(AE)	Trial comparisons
Placebo Combine With Chemotherapy vs TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy: deaths from any cause	Trial comparisons
Placebo Combine With Chemotherapy vs TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03581786

GET https://conductscience.org/api/trials/v1/NCT03581786/registered?page=2

API reference For AI assistants