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NCT02151448 · OUTCOME

Progression-free Survival (PFS)

αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies · Source last updated 2020-07-20

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 5 years

What was measured

The length of time during and after the treatment that patients remain alive with disease that does not progress. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in 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. (Note: the appearance of one or more new lesions is also considered progression).

Analysis population: Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment.

Groups in this outcome

α DC1 Vaccine + Chemokine Modulatory Regimen

α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)

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

Analysis denominator · Participants

GroupSource count
α DC1 Vaccine + Chemokine Modulatory Regimen20

Reported measurements

colon cancer
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
α DC1 Vaccine + Chemokine Modulatory Regimen19Not reported9NAUpper bound not reached for 95% CI
appendiceal cancer
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
α DC1 Vaccine + Chemokine Modulatory Regimen16Not reported14NAUpper bound not reached for 95% CI
Mesothelioma
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
α DC1 Vaccine + Chemokine Modulatory RegimenNANot reportedNANAMedian not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper bound not reached for 95% CI
        group Id
        OG000
        lower Limit
        9
        upper Limit
        NA
        value
        19
    title
    colon cancer
  2. categories
    1. measurements
      1. comment
        Upper bound not reached for 95% CI
        group Id
        OG000
        lower Limit
        14
        upper Limit
        NA
        value
        16
    title
    appendiceal cancer
  3. categories
    1. measurements
      1. comment
        Median not reached.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Mesothelioma
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The length of time during and after the treatment that patients remain alive with disease that does not progress. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in 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. (Note: the appearance of one or more new lesions is also considered progression).
dispersion Type
95% Confidence Interval
groups
  1. description
    α DC1 vaccine and Chemokine Modulatory Regimen: Celecoxib: Administered at 200 mg, once a day orally (T-TH) Rintatolimod: Intravenous infusion of 200 mg (Wed \& and Fri, only) Interferon Alfa-2b: Intravenous infusion - 5 MU/m\^2 or 20 MU/m\^2 (T-Fri)
    id
    OG000
    title
    α DC1 Vaccine + Chemokine Modulatory Regimen
param Type
MEDIAN
population Description
Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment.
reporting Status
POSTED
time Frame
Up to 5 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice