Trial · NCT03755791

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy

NCT03755791, Phase 3, Active not recruiting, Exelixis; results first posted 2025-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy. Trials, record NCT03755791. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03755791

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy
NCT number: NCT03755791
Status: Active not recruiting
Phases: Phase 3
Enrollment: 837 participants, actual
Lead sponsor: Exelixis
Conditions: Hepatocellular Carcinoma
Interventions: Cabozantinib, Cabozantinib, Sorafenib, Atezolizumab
First posted: 2018-11-28
Last updated: 2025-12-11
Results first posted: 2025-12-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population	From the date of first participant randomization up to 28 months	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.
Primary	Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population	From the date of first participant randomization up to 36 months	OS was defined as the time from randomization to death due to any cause.
Secondary	PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population	From the date of first participant randomization up to 28 months	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.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population	From the date of first participant randomization up to 28 months	PITT population included the first 372 participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.	months	MEDIAN
PRIMARY	Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population	From the date of first participant randomization up to 36 months	ITT population included all participants randomized to the experimental (cabozantinib + atezolizumab) arm and control (sorafenib) arm.	months	MEAN
SECONDARY	PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population	From the date of first participant randomization up to 28 months	ITT population included all participants randomized to the single agent cabozantinib arm and control (sorafenib) arm.	months	MEDIAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population	Experimental Arm: Cabozantinib + Atezolizumab	6.80	99% Confidence Interval 5.55 to 8.34	months
Progression Free Survival (PFS) for the Experimental Arm Versus the Control Arm in the PFS Intent to Treat (PITT) Population	Control Arm: Sorafenib	4.21	99% Confidence Interval 2.79 to 7.03	months
Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population	Experimental Arm: Cabozantinib + Atezolizumab	16.46	96% Confidence Interval 14.46 to 18.56	months
Overall Survival (OS) for the Experimental Arm Versus the Control Arm in the ITT Population	Control Arm: Sorafenib	15.51	96% Confidence Interval 12.19 to 19.98	months
PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population	Single-Agent Cabozantinib	5.82	99% Confidence Interval 5.42 to 8.18	months
PFS for the Single-Agent Cabozantinib Arm Versus the Control Arm in the ITT Population	Control Arm: Sorafenib	4.27	99% Confidence Interval 2.86 to 6.11	months

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental Arm: Cabozantinib + Atezolizumab	432
Overall Study	STARTED	Single-Agent Cabozantinib	188
Overall Study	STARTED	Control Arm: Sorafenib	217
Overall Study	Received At Least 1 Dose of Study Drug	Experimental Arm: Cabozantinib + Atezolizumab	429
Overall Study	Received At Least 1 Dose of Study Drug	Single-Agent Cabozantinib	188
Overall Study	Received At Least 1 Dose of Study Drug	Control Arm: Sorafenib	207
Overall Study	COMPLETED	Experimental Arm: Cabozantinib + Atezolizumab	0
Overall Study	COMPLETED	Single-Agent Cabozantinib	0
Overall Study	COMPLETED	Control Arm: Sorafenib	0
Overall Study	NOT COMPLETED	Experimental Arm: Cabozantinib + Atezolizumab	432

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events951

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Experimental Arm: Cabozantinib + Atezolizumab	55	429
other	Anaemia	Blood and lymphatic system disorders	Single-Agent Cabozantinib	23	188
other	Anaemia	Blood and lymphatic system disorders	Control Arm: Sorafenib	24	207
other	Neutropenia	Blood and lymphatic system disorders	Experimental Arm: Cabozantinib + Atezolizumab	37	429
other	Neutropenia	Blood and lymphatic system disorders	Single-Agent Cabozantinib	16	188
other	Neutropenia	Blood and lymphatic system disorders	Control Arm: Sorafenib	7	207
other	Thrombocytopenia	Blood and lymphatic system disorders	Experimental Arm: Cabozantinib + Atezolizumab	43	429
other	Thrombocytopenia	Blood and lymphatic system disorders	Single-Agent Cabozantinib	22	188
other	Thrombocytopenia	Blood and lymphatic system disorders	Control Arm: Sorafenib	11	207
other	Hypothyroidism	Endocrine disorders	Experimental Arm: Cabozantinib + Atezolizumab	93	429

1 to 10 of 951Source ClinicalTrials.gov

See all 951 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental Arm: Cabozantinib + Atezolizumab	307	429
Total, all-cause mortality	Single-Agent Cabozantinib	135	188
Total, all-cause mortality	Control Arm: Sorafenib	141	207
Total, other adverse events	Experimental Arm: Cabozantinib + Atezolizumab	414	429
Total, other adverse events	Single-Agent Cabozantinib	182	188
Total, other adverse events	Control Arm: Sorafenib	202	207
Total, serious adverse events	Experimental Arm: Cabozantinib + Atezolizumab	226	429
Total, serious adverse events	Single-Agent Cabozantinib	88	188
Total, serious adverse events	Control Arm: Sorafenib	85	207

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32491932	DERIVED	PubMed
35798016	DERIVED	PubMed
38364832	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03755791

GET https://conductscience.org/api/trials/v1/NCT03755791/events?page=2

API reference For AI assistants