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NCT03755791 · OUTCOME

Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy · Source last updated 2025-12-11

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

Measure
MEDIAN
Unit
months
Interval / dispersion
99% Confidence Interval
Time frame
From the date of first participant randomization up to 28 months

What was measured

PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Analysis population: PITT population included the first 372 participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.

Groups in this outcome

Experimental Arm: Cabozantinib + Atezolizumab

Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.

Control Arm: Sorafenib

Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.

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

Analysis denominator · Participants

GroupSource count
Experimental Arm: Cabozantinib + Atezolizumab250
Control Arm: Sorafenib122

Reported measurements

Source class 1
Values in months · Interval/dispersion: 99% Confidence Interval
GroupValueSpreadLowerUpperComment
Experimental Arm: Cabozantinib + Atezolizumab6.80Not reported5.558.34Not reported
Control Arm: Sorafenib4.21Not reported2.797.03Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    0.91
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0012
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    99
    ci Upper Limit
    0.91
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0012
    param Type
    Hazard Ratio (HR)
    param Value
    0.63
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.55
        upper Limit
        8.34
        value
        6.80
      2. group Id
        OG001
        lower Limit
        2.79
        upper Limit
        7.03
        value
        4.21
denoms
  1. counts
    1. group Id
      OG000
      value
      250
    2. group Id
      OG001
      value
      122
    units
    Participants
description
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression defined as a 20% increase in the sum of the longest diameters of target lesions, or the unequivocal appearance of new lesions, or progression of non-target disease per Blinded Independent Radiology Committee (BIRC) or the date of death due to any cause per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
dispersion Type
99% Confidence Interval
groups
  1. description
    Participants received 40 mg cabozantinib oral tablets once daily + 1200 mg IV infusion of atezolizumab once every 3 weeks for up to 38 months.
    id
    OG000
    title
    Experimental Arm: Cabozantinib + Atezolizumab
  2. description
    Participants received 400 mg sorafenib oral tablets twice daily for up to 38 months.
    id
    OG001
    title
    Control Arm: Sorafenib
param Type
MEDIAN
population Description
PITT population included the first 372 participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.
reporting Status
POSTED
time Frame
From the date of first participant randomization up to 28 months
title
Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice