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NCT05017103 · OUTCOME

Best Overall Response Rate

Sintilimab for the Treatment of Locally Advanced, Metastatic, Recurrent, or Unresectable Undifferentiated Pleomorphic Sarcoma, SiARa Cancer Study · Source last updated 2024-12-11

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At 12 weeks

What was measured

Will be defined as the proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1) in the evaluable population.

Analysis population: 2 participants not evaluable at 12 weeks (passed away)

Groups in this outcome

Treatment (Sintilimab)

Patients receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Sintilimab: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Sintilimab)4

Reported measurements

Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Sintilimab)3Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Sintilimab)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Progressive Disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Will be defined as the proportion of subjects with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1) in the evaluable population.
groups
  1. description
    Patients receive sintilimab IV over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Sintilimab: Given IV
    id
    OG000
    title
    Treatment (Sintilimab)
param Type
COUNT_OF_PARTICIPANTS
population Description
2 participants not evaluable at 12 weeks (passed away)
reporting Status
POSTED
time Frame
At 12 weeks
title
Best Overall Response Rate
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice