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NCT03581786 · OUTCOME

IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer · Source last updated 2025-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
up to 2 years

What was measured

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.

Groups in this outcome

Placebo Combine With Chemotherapy

Placebos: placebo combine with chemotherapy

TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy

TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo Combine With Chemotherapy143
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy146

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo Combine With Chemotherapy8.2Not reported7.039.79Not reported
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy21.4Not reported11.73NADue to insufficient number of participants with events, the upper limit of the survival curve hasn't reached 50%, there is no estimate for the upper confidence limit on the median.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.03
        upper Limit
        9.79
        value
        8.2
      2. comment
        Due to insufficient number of participants with events, the upper limit of the survival curve hasn't reached 50%, there is no estimate for the upper confidence limit on the median.
        group Id
        OG001
        lower Limit
        11.73
        upper Limit
        NA
        value
        21.4
denoms
  1. counts
    1. group Id
      OG000
      value
      143
    2. group Id
      OG001
      value
      146
    units
    Participants
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 (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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Placebos: placebo combine with chemotherapy
    id
    OG000
    title
    Placebo Combine With Chemotherapy
  2. description
    TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
    id
    OG001
    title
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
param Type
MEDIAN
reporting Status
POSTED
time Frame
up to 2 years
title
IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
type
PRIMARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice