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Comparison · NCT03829969-4cfcbb00

Toripalimab vs Placebo: ORR(Overall Response Rate:BICR)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Toripalimab vs Placebo: ORR(Overall Response Rate:BICR). Trial comparisons, record NCT03829969-4cfcbb00. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03829969-4cfcbb00

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.6930.6340.746wilson
Risk in group 20.5210.460.582wilson
Risk difference, group 1 minus group 20.1710.08690.252newcombe hybrid score
Risk ratio, group 1 over group 21.331.151.53log
Odds ratio, group 1 over group 22.071.442.97log
Number needed to treat, for one more participant with the outcome on Toripalimab than on Placebo5.843.9711.5from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1ToripalimabToripalimab combine with paclitaxel and cisplatin~Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy178257OG000
Group 2PlaceboPlacebo combine with paclitaxel and cisplatin~Toripalimab: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy134257OG001

Outcome

Type
SECONDARY
Title
ORR(Overall Response Rate:BICR)
Description
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.
Time frame
Up to 2 approximately years
Population

Source ClinicalTrials.gov

Trial

Title
Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma
NCT number
NCT03829969
Phases
PHASE3
Conditions
Advanced or Metastatic Esophageal Squamous Cell Cancer Without Previous Systemic Chemotherapy
Interventions
Toripalimab
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Results first posted
2024-05-02

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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