HCC Clinical Trial - Cabozantinib in Hepatocellular Carcinoma

Status Active, not recruiting

Clinical Trial Summary

There have been lack of clinical studies on the role of drug treatment in patients who develop progressive disease with immune checkpoint inhibitors. Amongst HCC patients who become intolerant or refractory to sorafenib, cabozantinib has been shown by phase III clinical trial (CELESTIAL) to prolong the overall survival of patients, as compared to placebo. It is expected more patients will be treated with immune checkpoint inhibitors in future, hence it is clinically important to study the efficacy and toxicity of cabozantinib after treatment with immune checkpoint inhibitors. Further, both MET activation and upregulation of regulatory T cells are implicated in resistance mechanism to immune checkpoint inhibitors. Immuno-modulatory effects of cabozantinib have been described in vitro and in murine models for several cancers. Moreover, cabozantinib appears to exert its effect on regulatory T cells (Tregs) via the HGF/c-Met pathway, where this receptor signaling cascade mediates multiple immune cell functions. HGF was shown to suppress DC function and in turn induce Tregs (CD4+ CD25+ FoxP3) in a murine central nervous system (CNS) autoimmunity model. HGF cultured monocytes differentiate into monocytic cells that produce soluble factors that favor immune suppressive conditions ideal for tumor progression. Above immunomodulatory effects could enable cabozantinib to reverse the immunosuppressive phenotype in patients after failure with immune checkpoint inhibitors. The starting dose of cabozantinib of 60mg once daily in the current study is chosen in accordance with approved dose by FDA for treatment of advanced HCC

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04588051
Study type	Interventional
Source	Chinese University of Hong Kong
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	November 1, 2020
Completion date	December 31, 2027

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05458115` - Clinical Study of MRD Recurrence Monitoring After Surgical Resection of Hepatocellular Carcinoma
Not yet recruiting	`NCT05022628` - Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis	Phase 4
Enrolling by invitation	`NCT02256514` - Open Label Trial of Immunotherapy for Advanced Liver Cancer	Phase 2
Not yet recruiting	`NCT06434480` - SBRT in HCC With Oligoprogression on Atezo-Bev	N/A
Completed	`NCT04542837` - The Study of KN046 in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma	Phase 2
Not yet recruiting	`NCT05025592` - cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC
Completed	`NCT04172506` - A Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody AK105 in Patients With Selected Advanced Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06024252` - Efficacy, Safety, and Treatment Patterns of Transcatheter Arterial Chemoembolization (TACE) Combined With Atezolizumab and Bevacizumab in Unresectable Hepatocellular Carcinoma: a Multicenter, Retrospective, Observational Real-world Study
Not yet recruiting	`NCT05840133` - Study of Long Non-coding RNA SNHG15 as a Novel Biomarker in HBV Associated HCC
Terminated	`NCT02785874` - Statin With Palliative Therapy for HCC	N/A
Not yet recruiting	`NCT02715492` - Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.	Phase 3
Completed	`NCT02985034` - Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT	N/A
Not yet recruiting	`NCT06069947` - SALT for Liver Cirrhosis With HCC	N/A
Recruiting	`NCT05581004` - A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors	Phase 1
Suspended	`NCT02935478` - Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation	N/A
Recruiting	`NCT05592171` - Occlusafe® Assisted MW Alone or With DEB-TACE Compared to MW With DEB-TACE in the Treatment of HCC	N/A
Completed	`NCT03176485` - Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors	N/A
Recruiting	`NCT05544253` - Safety and Efficacy of Mitomycin C-based HIPEC After srHCC and PM of HCC	Phase 2/Phase 3
Recruiting	`NCT06184152` - CEUS vs. AMRI for HCC Detection in Patients With Indeterminate Liver Nodules
Completed	`NCT02675920` - A Study of HCC High Risk Group Using Two Surveillance Tools