Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy

Phase 1

• Conditions: Hepatocellular carcinoma; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003354-24-BE
• Lead Sponsor: Exelixis, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-28
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

- Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by multiphase imaging using CT or MRI per the American Association for the Study of Liver Diseases (AASLD) guidelines or European Association for the Study of the Liver (EASL 2018)
- The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
- Measurable disease per RECIST 1.1 as determined by the Investigator. Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
- Child-Pugh Score of A.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 420

Exclusion Criteria

- Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.
- Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and ICIs. Subjects who have received local intratumoral or arterial chemotherapy are eligible. Subjects who have received any local anticancer therapy within 28 days prior to randomization are ineligible
- Radiation therapy for bone metastasis within 2 weeks, any other external beam radiation therapy within 8 weeks prior to randomization.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization..
- Concomitant anticoagulation with oral anticoagulants

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified