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NCT04588051
Cabozantinib in Hepatocellular Carcinoma
Phase 2 trial testing Cabozantinib in HCC in 20 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2027
Quick facts
| Lead sponsor | Stephen Chan Lam |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 November 2020 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 2 locations across Hong Kong, South Korea |
Drugs / interventions tested
- Cabozantinib (CABOZANTINIB) — full drug profile →
Conditions studied
- HCC — all drugs for HCC →
Sponsor
Stephen Chan Lam — full company profile →
Who can join
18 and older, any sex, with HCC. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multicentre phase II trial of cabozantinib in patients with hepatocellular carcinoma after immune checkpoint inhibitor treatment.
Chan SL, Ryoo BY, Mo F, Chan LL, et al · · 2024 · cited 41× · PMID 38570034 · DOI 10.1016/j.jhep.2024.03.033 -
Drug Treatment for Advanced Hepatocellular Carcinoma: First-Line and Beyond.
Feng MY, Chan LL, Chan SL. · · 2022 · cited 37× · PMID 36005172 · DOI 10.3390/curroncol29080434 -
The New Era of Systemic Treatment for Hepatocellular Carcinoma: From the First Line to the Optimal Sequence.
Cerreto M, Cardone F, Cerrito L, Stella L, et al · · 2023 · cited 26× · PMID 37887533 · DOI 10.3390/curroncol30100633 -
Cellular based immunotherapy for primary liver cancer.
Zheng Y, Li Y, Feng J, Li J, et al · · 2021 · cited 24× · PMID 34372912 · DOI 10.1186/s13046-021-02030-5 -
Real-world efficacy and safety of cabozantinib in Korean patients with advanced hepatocellular carcinoma: a multicenter retrospective analysis.
Bang YH, Lee CK, Yoo C, Chon HJ, et al · · 2022 · cited 15× · PMID 35602405 · DOI 10.1177/17588359221097934 -
Hepatocellular Carcinoma: Beyond the Border of Advanced Stage Therapy.
Zarlashat Y, Abbas S, Ghaffar A. · · 2024 · cited 7× · PMID 38893154 · DOI 10.3390/cancers16112034 -
Small-molecule-based targeted therapy in liver cancer.
Ming Y, Gong Y, Fu X, Ouyang X, et al · · 2024 · cited 6× · PMID 39113358 · DOI 10.1016/j.ymthe.2024.08.001 -
Transcription factor YBX1 orchestrates drug resistance and tumor progression in HCC.
Kwabiah D, Nagati V, Tripathi MK. · · 2025 · cited 3× · PMID 40716510 · DOI 10.1016/j.drudis.2025.104439
Verify or expand the search:
- PubMed search for NCT04588051
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz · Phase 1, PHASE2 · recruiting
- NCT07187869 — Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell · Phase 1 · not yet recruiting
- NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
- NCT06900595 — Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescent · Phase 2 · recruiting
Other recruiting trials for HCC
Currently open trials in the same condition.
- NCT07145801 — Y-90 Treatment Response Using Transarterial Radioembolization · Phase 2 · recruiting
- NCT07300488 — Efficacy and Safety of Pracytarabine Versus Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma · Phase 2, PHASE3 · active not recruiting
- NCT07334483 — A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC · Phase 2 · recruiting
- NCT07099274 — Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy f · Phase 2 · recruiting
- NCT06717919 — HOPE Against Cancer Recurrence in HCC · Phase 4 · recruiting
Other Stephen Chan Lam trials
Trials by the same sponsor.
- NCT05873244 — CXD101 in Immunotherapy-related Liver Cancer · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04588051 (US National Library of Medicine, public domain)
- 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 Stephen Chan Lam
- Last refreshed: 4 March 2026
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/NCT04588051.
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