Hepatocellular Carcinoma > Sorafenib
~61 spots leftby Apr 2026

Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

Recruiting in Palo Alto (17 mi)
+138 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

Research Team

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

Histologically-confirmed diagnosis of hepatocellular carcinoma
presence of measurable disease by radiographic imaging
Child-Pugh class A
See 2 more

Treatment Details

Interventions

  • Sorafenib (Tyrosine Kinase Inhibitor)
  • Sunitinib Malate (Tyrosine Kinase Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
sunitinib arm
Group II: Arm BActive Control1 Intervention
sorafenib arm

Sorafenib is already approved in Canada, Japan for the following indications:

🇨🇦
Approved in Canada as Nexavar for:
  • Renal cell carcinoma
  • Hepatocellular carcinoma
🇯🇵
Approved in Japan as Nexavar for:
  • Renal cell carcinoma
  • Hepatocellular carcinoma

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Pfizer Investigational SiteChattanooga, TN
Pfizer Investigational SiteFranklin, TN
Pfizer Investigational SiteRinggold, GA
Pfizer Investigational SiteFairfield, OH
More Trial Locations
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Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4712
Patients Recruited
50,980,000+
Known For
Vaccine Innovations
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