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NCT05185947 · OUTCOME

Clinicopathologic Response to Therapy by Peritoneal Carcinomatosis Index (PCI) Reported for All Participants Along With a 95% Confidence Interval

Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis · Source last updated 2026-06-25

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, every 9 weeks during treatment, and then every 3 months for 2 years

What was measured

Clinicopathologic response by PCI is reported with a 95% confidence interval. Complete Response (CR) is PCI ≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI.

Analysis population: 7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.

Groups in this outcome

Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1

Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).

Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1

Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.

Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1

Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).

Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1

Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).

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

Analysis denominator · Participants

GroupSource count
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 14
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 11
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -11
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -11

Reported measurements

Complete Response: PCI ≤ 5
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -11.0Not reported1.01.0Not reported
Partial Response: At least 4 points decrease in PCI
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -10.0Not reported0.00.0Not reported
Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase for PD
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1100Not reported39.8100.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1100Not reported100.0100.0Not reported
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1100Not reported100.0100.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1100Not reported100.0100.0Not reported
Progressive Disease: At least 4 points increase in PCI
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -10.0Not reported0.00.0Not reported
Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -10.0Not reported0.00.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      4. group Id
        OG003
        lower Limit
        1.0
        upper Limit
        1.0
        value
        1.0
    title
    Complete Response: PCI ≤ 5
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
    title
    Partial Response: At least 4 points decrease in PCI
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.8
        upper Limit
        100.0
        value
        100
      2. group Id
        OG001
        lower Limit
        100.0
        upper Limit
        100.0
        value
        100
      3. group Id
        OG002
        lower Limit
        100.0
        upper Limit
        100.0
        value
        100
      4. group Id
        OG003
        lower Limit
        100.0
        upper Limit
        100.0
        value
        100
    title
    Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase for PD
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        0.0
        value
        0.0
    title
    Progressive Disease: At least 4 points increase in PCI
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    units
    Participants
description
Clinicopathologic response by PCI is reported with a 95% confidence interval. Complete Response (CR) is PCI ≤ 5 with negative histology of at least 3 peritoneal biopsies of suspect nodules and washings with negative cytology. Partial Response (PR) is at least 4 points decrease in PCI. Progressive Disease (PD) is at least 4 points increase in PCI. The appearance of one or more new lesions is also considered progression. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the PCI.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ended treatment at the regular dose level: 80 intravenous (IV)/80 Intraperitoneal (IP) + 300 twice a day (BID).
    id
    OG000
    title
    Intravenous Paclitaxel Dose Level 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
  2. description
    Had the planned doses for Intraperitoneal (IP) Paclitaxel (80 IP) and by mouth (PO) nilotinib (300 twice a day (BID) but declined to go up to the 80mg/m\^2 of intravenous (IV) Paclitaxel.
    id
    OG001
    title
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level 1
  3. description
    Had the planned doses for intravenous (IV) and Intraperitoneal (IP) Paclitaxel (80 IV/80 IP) but had a dose reduction for Nilotinib (400 every day (QD).
    id
    OG002
    title
    Intravenous Paclitaxel DoseLevel 1, Intraperitoneal Paclitaxel Dose Level 1, Nilotinib Dose Level -1
  4. description
    Had the planned dose of Intraperitoneal (IP) Paclitaxel (80 IP) but had a dose reduction for intravenous (IV) Paclitaxel (60 IV), and a dose reduction for Nilotinib (400 every day (QD).
    id
    OG003
    title
    Intravenous Paclitaxel DoseLevel -1, Intraperitoneal Paclitaxel DoseLevel 1, Nilotinib Dose Level -1
param Type
NUMBER
population Description
7/21 participants were analyzed because 12 participants were not treated and 2 refused further treatment.
reporting Status
POSTED
time Frame
Baseline, every 9 weeks during treatment, and then every 3 months for 2 years
title
Clinicopathologic Response to Therapy by Peritoneal Carcinomatosis Index (PCI) Reported for All Participants Along With a 95% Confidence Interval
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice