18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Overall Survival (OS) Following Treatment With Tivantinib 120 mg BID Compared to Placebo Group in Participants With MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Systemic TherapyPrimary· within 36 months
Overall survival (OS) is defined as the time from randomization to the date of death. The rate of OS (percentage of participants still alive) was determined only in the tivantinib 120 mg BID cohort.
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
8.4
6.8 – 10.0
Placebo Matching 120 mg BID Cohort
9.1
7.3 – 10.4
Overall Survival (OS) Rate At Different Time Points Following Treatment With Tivantinib 120 mg BID Compared to Placebo Group in Participants With MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Systemic TherapyPrimary· within 36 months
Overall survival (OS) is defined as the time from randomization to the date of death. The rate of OS (percentage of participants still alive) was determined only in the tivantinib 120 mg BID cohort.
Overall survival at 3 months
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
86.6
81.4 – 90.5
Placebo Matching 120 mg BID Cohort
85.9
78.0 – 91.1
Overall survival at 6 months
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
61.2
54.5 – 67.2
Placebo Matching 120 mg BID Cohort
70.8
61.5 – 78.3
Overall survival at 9 months
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
46.9
40.2 – 53.3
Placebo Matching 120 mg BID Cohort
50.5
40.9 – 59.2
Overall survival at 12 months
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
36.6
30.3 – 42.9
Placebo Matching 120 mg BID Cohort
38.0
29.1 – 46.9
Overall survival at 18 months
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
25.1
19.4 – 31.2
Placebo Matching 120 mg BID Cohort
21.9
14.3 – 30.5
Overall survival at 24 months
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
16.2
11.0 – 22.3
Placebo Matching 120 mg BID Cohort
12.2
5.9 – 20.8
Progression-free Survival Following Treatment With Tivantinib 120 mg BID Compared to Placebo Group in Participants With MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Systemic Therapy (ITT Population)Secondary· within 10 months
Progression-free survival (PFS) is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause. The rate of PFS (percentage of participants still alive without disease progression) was determined only in the tivantinib 120 mg BID cohort.
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
2.1
1.9 – 3.0
Placebo Matching 120 mg BID Cohort
2.0
1.9 – 3.6
Treatment-Emergent Adverse Events Reported (>20% in Tivantinib Cohort) Following Treatment With Tivantinib Compared With Placebo in Participants With MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Systemic TherapySecondary· Baseline to 30 days after last dose, up to approximately 4 years
Treatment-emergent adverse events (TEAEs) are reported for the tivantinib 120 mg BID cohort group.
Any TEAEs
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
214
Placebo Matching 120 mg BID Cohort
108
Gastrointestinal Disorders
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
159
Placebo Matching 120 mg BID Cohort
84
General Disorders & Administration Site Conditions
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
146
Placebo Matching 120 mg BID Cohort
75
Musculoskeletal and Connective Tissue Disorders
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
75
Placebo Matching 120 mg BID Cohort
34
Respiratory, Thoracic, and Mediastinal Disorders
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
70
Placebo Matching 120 mg BID Cohort
32
Metabolism and Nutrition Disorders
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
65
Placebo Matching 120 mg BID Cohort
30
Blood and Lymphatic System Disorders
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
64
Placebo Matching 120 mg BID Cohort
27
Nervous System Disorders
Group
Value
95% CI
Tivantinib 120 mg BID Cohort
60
Placebo Matching 120 mg BID Cohort
27
Treatment-Emergent Adverse Events Reported (>20% in Tivantinib Cohort) Following Treatment With Tivantinib Compared With Placebo in Participants With MET Diagnostic-High Inoperable Hepatocellular Carcinoma (HCC) Treated With One Prior Systemic TherapySecondary· Baseline to 30 days after last dose, up to approximately 4 years
Treatment-emergent adverse events (TEAEs) are reported for the tivantinib 240 mg BID cohort group.
Any TEAEs
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
28
Placebo Matching 240 mg BID Cohort
14
Blood and Lymphatic System Disorders
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
20
Placebo Matching 240 mg BID Cohort
4
Gastrointestinal Disorders
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
20
Placebo Matching 240 mg BID Cohort
12
General Disorders & Administration Site Conditions
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
19
Placebo Matching 240 mg BID Cohort
9
Investigations
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
11
Placebo Matching 240 mg BID Cohort
8
Respiratory, Thoracic, and Mediastinal Disorders
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
8
Placebo Matching 240 mg BID Cohort
4
Infections and Infestations
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
7
Placebo Matching 240 mg BID Cohort
3
Skin and Subcutaneous Tissue Disorders
Group
Value
95% CI
Tivantinib 240 mg BID Cohort
7
Placebo Matching 240 mg BID Cohort
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were collected from baseline to 30 days after the last dose up to approximately 4 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01749384 — Tivantinib and Bevacizumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
· Phase 1
· completed
NCT01688973 — Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cance
· Phase 2
· completed
NCT01696955 — Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Ca
· Phase 2
· completed
NCT01654965 — Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
· Phase 1
· completed
NCT01519414 — Tivantinib in Treating Patients With Metastatic Prostate Cancer
· Phase 2
· completed
Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma
· Phase 2
· recruiting
NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors
· Phase 3
· recruiting
NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma
· Phase 2
· recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer
· Phase 1
· recruiting
Other Daiichi Sankyo trials
Trials by the same sponsor.
NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
· Phase 3
· not yet recruiting
NCT07206472 — A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholestero
· active not recruiting
NCT07220616 — A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
· Phase 1, PHASE2
· recruiting
NCT07268625 — Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorv
· Phase 1
· completed
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (
· Phase 1
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 6 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01755767.