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Sorafenib

Generic Name
Sorafenib
Brand Names
Nexavar, Sorafenib Accord
Drug Type
Small Molecule
Chemical Formula
C21H16ClF3N4O3
CAS Number
284461-73-0
Unique Ingredient Identifier
9ZOQ3TZI87
Background

Sorafenib is a bi-aryl urea and an oral multikinase inhibitor. It targets cell surface tyrosine kinase receptors and downstream intracellular kinases that are implicated in tumour cell proliferation and tumour angiogenesis. First approved by the FDA and European Commission in 2007 for the treatment of hepatocellular carcinoma, sorafenib is also indicated to treat renal carcinoma and differentiated thyroid carcinoma.

Indication

Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

In the US, it is also indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.

Associated Conditions
Advanced Renal Cell Carcinoma, Angiosarcoma, Gastrointestinal Stromal Tumor (GIST), Leiomyosarcoma (LMS), Unresectable Hepatocellular Carcinoma (HCC), Progressive, locally recurrent radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC), Progressive, metastatic radioactive iodine-refractory Differentiated Thyroid Carcinoma (DTC)

Combined Immunotherapy and Targeted Therapy for Advanced Liver Cancer

Phase 3
Conditions
Advanced Liver Cancer
Interventions
Drug: PD-1
First Posted Date
2019-11-14
Last Posted Date
2019-11-14
Lead Sponsor
Guangxi Medical University
Target Recruit Count
50
Registration Number
NCT04163237
Locations
🇨🇳

TaoBai, Nanning, Guangxi, China

Combined Immunotherapy and Targeted Therapy for Hepatocellular Carcinoma

Conditions
HepatoCellular Carcinoma
Interventions
Drug: PD-1
First Posted Date
2019-11-05
Last Posted Date
2019-11-05
Lead Sponsor
Guangxi Medical University
Target Recruit Count
50
Registration Number
NCT04152356
Locations
🇨🇳

TaoBai, Nanning, Guangxi, China

Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC

Phase 3
Conditions
Hepatocellular Carcinoma
Interventions
Procedure: Transarterial chemoembolization
First Posted Date
2019-10-29
Last Posted Date
2020-03-25
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
158
Registration Number
NCT04143191
Locations
🇨🇳

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

HAIC Plus Toripalimab vs. HAIC Plus Sorafenib for HCC With PVTT: a Non-comparative, Prospective, Randomized Trial

Phase 2
Recruiting
Conditions
Hepatocellular Carcinoma
Interventions
Procedure: Hepatic arterial infusion chemotherapy
Drug: systemic treatment
First Posted Date
2019-10-23
Last Posted Date
2023-08-15
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
60
Registration Number
NCT04135690
Locations
🇨🇳

Cancer Center Sun Yat-sen University, Guangzhou, Guangdong, China

Lenvatinib Plus TACE Versus Sorafenib Plus TACE for HCC With PVTT

Phase 4
Conditions
Carcinoma, Hepatocellular
Portal Vein Tumor Thrombus
Interventions
Procedure: Transarterial chemoembolization(TACE)
First Posted Date
2019-10-15
Last Posted Date
2021-07-23
Lead Sponsor
Beijing Ditan Hospital
Target Recruit Count
72
Registration Number
NCT04127396
Locations
🇨🇳

Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing, China

Sorafenib PK in Patients With Advanced HCC and Child-Pugh B

Phase 2
Terminated
Conditions
CP-B Liver Cirrhosis
BCLC Stage C HCC
Interventions
Other: CYP cocktail clearance test
Other: Midazolam clearance test
First Posted Date
2019-08-09
Last Posted Date
2019-08-21
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
5
Registration Number
NCT04051853
Locations
🇳🇱

Academic Medical Center, Amsterdam, Netherlands

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

Phase 3
Active, not recruiting
Conditions
Hepatocellular Carcinoma
Interventions
First Posted Date
2019-07-31
Last Posted Date
2024-05-02
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
732
Registration Number
NCT04039607
Locations
🇺🇸

Local Institution - 0295, Newark, New Jersey, United States

🇧🇷

Local Institution - 0061, Salvador, Bahia, Brazil

🇦🇺

Local Institution - 0038, Liverpool, New South Wales, Australia

and more 202 locations

A Randomized Phase II Trial of Surgery Plus Sorafenib vs. Sorafenib Alone for Hepatocellular Cancer (HCC) With Portal Vein Invasion

Phase 2
Conditions
Hepatocellular Cancer
Interventions
Procedure: hepatic resection
First Posted Date
2019-06-03
Last Posted Date
2021-04-14
Lead Sponsor
White Plains Hospital
Target Recruit Count
200
Registration Number
NCT03971201
Locations
🇨🇳

Eastern Hepatobiliary Surgery Hospital, Shanghai, China

Immune Checkpoint Therapy vs Target Therapy in Reducing Serum HBsAg Levels in Patients With HBsAg+ Advanced Stage HCC

Phase 2
Recruiting
Conditions
Hepatocellular Carcinoma
Interventions
First Posted Date
2019-04-02
Last Posted Date
2025-03-24
Lead Sponsor
Humanity & Health Medical Group Limited
Target Recruit Count
30
Registration Number
NCT03899428
Locations
🇭🇰

Humanity & Health Research Centre, Hong Kong, Hong Kong SAR, Hong Kong

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1
Terminated
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma
Interventions
First Posted Date
2019-03-18
Last Posted Date
2024-03-04
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT03878524
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

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