Cabozantinib to Treat Recurrent Liver Cancer Post Transplant

NCT04204850 | Recruiting Phase 2 DMC

• 2 other identifiers: CaboTxCAPCR 19-6312
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients. Cabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors. All participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.

Conditions

Recurrent Cancer; Liver Transplant; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  Proportion of patients with complete response + partial response + stable disease.

  4 months

Secondary Outcomes (3)

• Progression-free survival

  3 years

• Overall survival

  3 years

• Number of Side Effects Reported

  3 years

Study Arms (1)

Cabozantinib

EXPERIMENTAL

Cabozantinib, at a dose of 60 mg orally (by mouth), once a day (at bedtime), continuously.

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Cabozantinib is a multi-tyrosine kinase inhibitor with activity against VEGFR 1,2,3, MET and AXL, as well as RET, KIT, ant FLT-3.

Also known as: CABOMETYX

Cabozantinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histologically or cytologically confirmed hepatocellular carcinoma that has recurred.
• Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma (HCC).
• Not amenable to curative surgery or local treatment for recurrent disease.
• Must have measurable disease.
• No prior treatment with cabozantinib. May be systemic therapy naïve or have received up to 1 line of prior therapy for advanced HCC with sorafenib or lenvatinib.
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 01.
• Life expectancy of \>3 months.
• Normal organ and marrow function.
• Adequate cardiac function.
• No evidence of active uncontrolled infection.
• Understand and willing to sign written informed consent document.
• Recovered from prior toxicities to \< grade 1.
• Able to take oral medications.
• Agree to use effective contraceptive methods until at least 30 days (for women) and 3 months (for men) after the last administration of study medication. Serum pregnancy test should be negative.

You may not qualify if:

• Had systemic therapy or radiotherapy \<3 weeks.
• Receiving any other investigational agents.
• With known brain metastases unless stable for \>3 months.
• History of allergic reactions attributed to cabozantinib.
• Has uncontrolled, significant intercurrent or recent illness:
• Cardiovascular disorders
• Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
• Major surgery within 2 months before randomization
• Cavitating pulmonary lesion(s) or endobronchial disease (untreated)
• Lesion invading a major blood vessel
• Clinically significant bleeding risk \<3 months
• Other clinically significant disorders:
• Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness
• Serious non-healing wound/ulcer/bone fracture
• Malabsorption syndrome

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ipsen: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (2)

• Azhie A, Grant RC, Herman M, Wang L, Knox JJ, Bhat M. Phase II clinical trial of cabozantinib for the treatment of recurrent hepatocellular carcinoma after liver transplantation. Future Oncol. 2022 Jun;18(18):2173-2191. doi: 10.2217/fon-2021-1635. Epub 2022 Mar 15.

  PMID: 35287469 DERIVED

• D'Alessio A, Cammarota A, Prete MG, Pressiani T, Rimassa L. The evolving treatment paradigm of advanced hepatocellular carcinoma: putting all the pieces back together. Curr Opin Oncol. 2021 Jul 1;33(4):386-394. doi: 10.1097/CCO.0000000000000744.

  PMID: 33867478 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Knox, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Knox, M.D.

CONTACT

416-946-2399; jennifer.knox@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: August 7, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)