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NCT03581786 · OUTCOME

DoR IRC-assessed Per irRECIST

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
From date of response until progressive disease. Up to 2 approximately years

What was measured

To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.

Analysis population: NE below means "not estimable"

Groups in this outcome

Placebo Combine With Chemotherapy

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

TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy

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

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 Chemotherapy97
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy115

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo Combine With Chemotherapy5.9Not reported5.558.25Not reported
TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy20.1Not reported14.09NADue to insufficient number of participants with events, the upper limit of the survival curve has not 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
        5.55
        upper Limit
        8.25
        value
        5.9
      2. comment
        Due to insufficient number of participants with events, the upper limit of the survival curve has not reached 50%, there is no estimate for the upper confidence limit on the median.
        group Id
        OG001
        lower Limit
        14.09
        upper Limit
        NA
        value
        20.1
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    2. group Id
      OG001
      value
      115
    units
    Participants
description
To evaluate DoR of JS001 plus chemotherapy compared with placebo plus chemotherapy according to irRECIST.
dispersion Type
95% Confidence Interval
groups
  1. description
    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
    id
    OG000
    title
    Placebo Combine With Chemotherapy
  2. description
    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
    id
    OG001
    title
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
param Type
MEDIAN
population Description
NE below means "not estimable"
reporting Status
POSTED
time Frame
From date of response until progressive disease. Up to 2 approximately years
title
DoR IRC-assessed Per irRECIST
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice