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NCT03755791 · OUTCOME

PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT 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 per BIRC or the date of death due to any cause per RECIST version 1.1.

Analysis population: ITT population included all participants randomized to the single agent cabozantinib arm and control (sorafenib) arm.

Groups in this outcome

Single-Agent Cabozantinib

Participants received 60 mg cabozantinib oral tablets once daily 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
Single-Agent Cabozantinib188
Control Arm: Sorafenib217

Reported measurements

Source class 1
Values in months · Interval/dispersion: 99% Confidence Interval
GroupValueSpreadLowerUpperComment
Single-Agent Cabozantinib5.82Not reported5.428.18Not reported
Control Arm: Sorafenib4.27Not reported2.866.11Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.42
        upper Limit
        8.18
        value
        5.82
      2. group Id
        OG001
        lower Limit
        2.86
        upper Limit
        6.11
        value
        4.27
denoms
  1. counts
    1. group Id
      OG000
      value
      188
    2. group Id
      OG001
      value
      217
    units
    Participants
description
PFS was defined as the time from randomization to the earlier of either the date of radiographic progression per BIRC or the date of death due to any cause per RECIST version 1.1.
dispersion Type
99% Confidence Interval
groups
  1. description
    Participants received 60 mg cabozantinib oral tablets once daily for up to 38 months.
    id
    OG000
    title
    Single-Agent Cabozantinib
  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
ITT population included all participants randomized to the single agent cabozantinib arm and control (sorafenib) arm.
reporting Status
POSTED
time Frame
From the date of first participant randomization up to 28 months
title
PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice