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NCT03710876 · OUTCOME

Best Response: Disease Control Rate (DCR)

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma · Source last updated 2026-04-21

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
4 years and 8 months

What was measured

Disease control rate (DCR) was defined as the proportion of patients with a BOR of CR, PR, or Stable Disease (SD).

Analysis population: The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).

Groups in this outcome

Treatment Group

rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

Control Group

Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

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 Group27
Control Group22

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment Group19Not reportedNot reportedNot reportedNot reported
Control Group15Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -25.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    29.2
    estimate Comment
    Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.0000
    param Type
    Risk Difference (RD)
    param Value
    2.2
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Lower Limit
    -25.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    29.2
    estimate Comment
    Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    1.0000
    param Type
    Risk Difference (RD)
    param Value
    2.2
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      22
    units
    Participants
description
Disease control rate (DCR) was defined as the proportion of patients with a BOR of CR, PR, or Stable Disease (SD).
groups
  1. description
    rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    OG000
    title
    Treatment Group
  2. description
    Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    OG001
    title
    Control Group
param Type
COUNT_OF_PARTICIPANTS
population Description
The Full Analysis Set, which comprised all patients who were appropriately randomized into the study and who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).
reporting Status
POSTED
time Frame
4 years and 8 months
title
Best Response: Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice