Trial · NCT03829969
Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma
NCT03829969, Phase 3, Completed, Shanghai Junshi Bioscience Co., Ltd.; results first posted 2024-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma. Trials, record NCT03829969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03829969
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma
- NCT number
- NCT03829969
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 514 participants, actual
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Conditions
- Advanced or Metastatic Esophageal Squamous Cell Cancer Without Previous Systemic Chemotherapy
- Interventions
- Toripalimab
- First posted
- 2019-02-04
- Last updated
- 2025-07-23
- Results first posted
- 2024-05-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS((Progression-Free Surviv) | PFS: up to 2years | To evaluate the differences in PFS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review \[BICR\] per RECIST 1.1 criteria). |
| Primary | OS (Overall Survival) | up to 2 years | To evaluate the differences in OS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review \[BICR\] per RECIST 1.1 criteria) |
| Secondary | ORR(Overall Response Rate:BICR) | Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed overall response rate (ORR), daccording to RECIST v1.1; ORR:Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | DCR(Disease Control Rate:BICR ) | Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed disease control rate (DCR) according to RECIST v1.1 DCR is defined as the proportion of patients with the best efficacy of CR or PR or SD. |
| Secondary | DOR(Duration of Response: Recist 1.1,BICR ) | Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed duration of response (DoR) according to RECIST v1.1 DOR is defined as the time from first documented response to first documented evidence of disease progression or to death, whichever comes first. |
| Secondary | TTR(Time to Initial Response:BICR ) | Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by blind independent review committee BIRC and investigator-assessed Time to initial Response (TTR) according to RECIST v1.1 TTR is defined as the time from randomization to the first recorded response (CR or PR). |
| Secondary | PFS | Up to 2 approximately years | To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy，as measured by investigator-assessed progression free survival (PFS) according to RECIST v1.1 |
| Secondary | PFS Rate:BICR | Up to 1 years | 1 years PFS rate |
| Secondary | OS Rate | up to 2 years | 2 years OS rate |
| Secondary | PFS Assessed Per 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 | To evaluate PFS of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PFS((Progression-Free Surviv) | PFS: up to 2years | months | MEDIAN | |
| PRIMARY | OS (Overall Survival) | up to 2 years | months | MEDIAN | |
| SECONDARY | ORR(Overall Response Rate:BICR) | Up to 2 approximately years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | DCR(Disease Control Rate:BICR ) | Up to 2 approximately years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | DOR(Duration of Response: Recist 1.1,BICR ) | Up to 2 approximately years | months | MEDIAN | |
| SECONDARY | TTR(Time to Initial Response:BICR ) | Up to 2 approximately years | months | MEDIAN | |
| SECONDARY | PFS | Up to 2 approximately years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PFS Rate:BICR | Up to 1 years | Percentage of Participants | NUMBER | |
| SECONDARY | OS Rate | up to 2 years | Percentage of Participants | NUMBER | |
| SECONDARY | PFS Assessed Per 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 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| PFS((Progression-Free Surviv) | Toripalimab | 5.7 | 95% Confidence Interval 5.6 to 7.0 | months | |
| PFS((Progression-Free Surviv) | Placebo | 5.5 | 95% Confidence Interval 5.2 to 5.6 | months | |
| OS (Overall Survival) | Toripalimab | 17.7 | 95% Confidence Interval 14.6 to 20.8 | months | |
| OS (Overall Survival) | Placebo | 12.9 | 95% Confidence Interval 11.6 to 14.1 | months | |
| ORR(Overall Response Rate:BICR) | Toripalimab | 178 | Participants | ||
| ORR(Overall Response Rate:BICR) | Placebo | 134 | Participants | ||
| DCR(Disease Control Rate:BICR ) | Toripalimab | 229 | Participants | ||
| DCR(Disease Control Rate:BICR ) | Placebo | 211 | Participants | ||
| DOR(Duration of Response: Recist 1.1,BICR ) | Toripalimab | 5.6 | 95% Confidence Interval 4.4 to 8.7 | months | |
| DOR(Duration of Response: Recist 1.1,BICR ) | Placebo | 4.2 | 95% Confidence Interval 4.2 to 4.4 | months |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Toripalimab | 257 | |
| Overall Study | STARTED | Placebo | 257 | |
| Overall Study | COMPLETED | Toripalimab | 257 | |
| Overall Study | COMPLETED | Placebo | 257 | |
| Overall Study | NOT COMPLETED | Toripalimab | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
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 | Events |
|---|---|---|---|---|---|---|
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Toripalimab | 234 | 257 | |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Placebo | 228 | 257 | |
| other | gastrointestinal disors | Gastrointestinal disorders | Toripalimab | 201 | 257 | |
| other | gastrointestinal disors | Gastrointestinal disorders | Placebo | 202 | 257 | |
| other | Metabolism and nutrition disorders | Metabolism and nutrition disorders | Toripalimab | 189 | 257 | |
| other | Metabolism and nutrition disorders | Metabolism and nutrition disorders | Placebo | 194 | 257 | |
| other | Investigations | Investigations | Toripalimab | 166 | 257 | |
| other | Investigations | Investigations | Placebo | 152 | 257 | |
| other | General disorders | General disorders | Toripalimab | 166 | 257 | |
| other | General disorders | General disorders | Placebo | 152 | 257 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Toripalimab | 174 | 257 |
| Total, all-cause mortality | Placebo | 198 | 257 |
| Total, other adverse events | Toripalimab | 255 | 257 |
| Total, other adverse events | Placebo | 255 | 257 |
| Total, serious adverse events | Toripalimab | 93 | 257 |
| Total, serious adverse events | Placebo | 74 | 257 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Toripalimab vs Placebo: PFS Assessed Per irRECIST | Trial comparisons |
| Toripalimab vs Placebo: ORR Assessed Per irRECIST | Trial comparisons |
| Toripalimab vs Placebo: ORR(Overall Response Rate:BICR) | Trial comparisons |
| Toripalimab vs Placebo: DCR Assessed Per irRECIST | Trial comparisons |
| Toripalimab vs Placebo: DCR(Disease Control Rate:BICR ) | Trial comparisons |
| Toripalimab vs Placebo: deaths from any cause | Trial comparisons |
| Toripalimab vs Placebo: PFS | Trial comparisons |
| Toripalimab vs Placebo: 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.
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/NCT03829969
GET https://conductscience.org/api/trials/v1/NCT03829969/results?page=2