NCT03275376

Statin Combination Therapy in Patients Receiving Sorafenib for Advanced Hepatocellular Carcinoma

Terminated Phase 2 Last updated 16 March 2021

What this trial tests

Phase 2 trial testing Atorvastatin 10mg in Overall Survival in 34 participants. Terminated before completion.

Timeline

21 December 2017

Primary endpoint
21 December 2020

13 March 2021

Quick facts

Lead sponsor	Taichung Veterans General Hospital
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	34
Start date	21 December 2017
Primary completion	21 December 2020
Estimated completion	13 March 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• Atorvastatin 10mg — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Overall Survival — all drugs for Overall Survival →
• Tumor Responses — all drugs for Tumor Responses →

Sponsor

Taichung Veterans General Hospital

Who can join

40 and older, any sex, with Overall Survival or Tumor Responses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Target therapy with sorafenib is the standard of treatment for advanced Hepatocellular carcinoma (HCC), but the patient survival time is still unsatisfactory. The aims of this study are to prove statins improve the tumor responses and overall survival for patients who receive sorafenib therapy for advanced HCC by a prospective randomized controlled study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The updated landscape of tumor microenvironment and drug repurposing.
   Jin MZ, Jin WL. · · 2020 · cited 900× · PMID 32843638 · DOI 10.1038/s41392-020-00280-x
2. The Lipid Metabolic Landscape of Cancers and New Therapeutic Perspectives.
   Wang W, Bai L, Li W, Cui J. · · 2020 · cited 86× · PMID 33364199 · DOI 10.3389/fonc.2020.605154
3. The Innovative Potential of Statins in Cancer: New Targets for New Therapies.
   Di Bello E, Zwergel C, Mai A, Valente S. · · 2020 · cited 84× · PMID 32626692 · DOI 10.3389/fchem.2020.00516
4. Metabolic reprogramming in the immunosuppression of tumor-associated macrophages.
   Wang Y, Wang D, Yang L, Zhang Y. · · 2022 · cited 36× · PMID 36385099 · DOI 10.1097/cm9.0000000000002426
5. NASH, Fibrosis and Hepatocellular Carcinoma: Lipid Synthesis and Glutamine/Acetate Signaling.
   Sunami Y. · · 2020 · cited 18× · PMID 32947972 · DOI 10.3390/ijms21186799
6. Current and novel approaches in the pharmacological treatment of hepatocellular carcinoma.
   Villarruel-Melquiades F, Mendoza-Garrido ME, García-Cuellar CM, Sánchez-Pérez Y, et al · · 2023 · cited 14× · PMID 37213397 · DOI 10.3748/wjg.v29.i17.2571
7. Statin therapy: a potential adjuvant to immunotherapies in hepatocellular carcinoma.
   Wang J, Liu C, Hu R, Wu L, et al · · 2024 · cited 13× · PMID 38362156 · DOI 10.3389/fphar.2024.1324140
8. Leveraging altered lipid metabolism in treating B cell malignancies.
   Lee J, Mani A, Shin MJ, Krauss RM. · · 2024 · cited 11× · PMID 38964473 · DOI 10.1016/j.plipres.2024.101288