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TACE plus sorafenib
TACE plus sorafenib is a Combination therapy (locoregional procedure + multi-kinase inhibitor) Small molecule drug developed by Guangxi Medical University. It is currently in Phase 3 development for Hepatocellular carcinoma (HCC), intermediate to advanced stage.
TACE (transarterial chemoembolization) combined with sorafenib delivers chemotherapy directly to liver tumors while sorafenib inhibits multiple tyrosine kinases to suppress tumor angiogenesis and growth.
TACE (Transarterial Chemoembolization) combined with sorafenib is being studied as a treatment for Hepatocellular Carcinoma. Sorafenib is a small molecule serine/threonine-protein kinase RAF inhibitor.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | TACE plus sorafenib |
|---|---|
| Sponsor | Guangxi Medical University |
| Drug class | Combination therapy (locoregional procedure + multi-kinase inhibitor) |
| Target | VEGFR, PDGFR, RAF kinases (sorafenib component) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
TACE is a locoregional procedure that embolizes the hepatic artery feeding the tumor while delivering chemotherapy directly to the lesion. Sorafenib is a multi-kinase inhibitor targeting VEGFR, PDGFR, RAF, and FLT3, which blocks tumor angiogenesis and proliferation. The combination aims to enhance local tumor control via TACE while systemic sorafenib prevents residual disease and metastatic progression.
Approved indications
- Hepatocellular carcinoma (HCC), intermediate to advanced stage
Common side effects
- Hand-foot skin reaction
- Diarrhea
- Fatigue
- Hypertension
- Hepatic dysfunction
- Post-embolization syndrome (fever, pain, nausea)
Key clinical trials
- CECT Features of MVI Predict Response to TACE Plus TKI in Intermediate-stage HCC
- Sorafenib Chemoembolization Evaluation Controlled Trial (PHASE3)
- HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC (PHASE3)
- TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC (PHASE2)
- Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma
- TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma (PHASE3)
- Survival Analysis: TACE vs. Combination Therapy in HCC
- A Retrospective Study on the Treatment of Intermediate and Advanced Liver Cancer.
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TACE plus sorafenib CI brief — competitive landscape report
- TACE plus sorafenib updates RSS · CI watch RSS
- Guangxi Medical University portfolio CI
Frequently asked questions about TACE plus sorafenib
What is TACE plus sorafenib?
How does TACE plus sorafenib work?
What is TACE plus sorafenib used for?
Who makes TACE plus sorafenib?
What drug class is TACE plus sorafenib in?
What development phase is TACE plus sorafenib in?
What are the side effects of TACE plus sorafenib?
What does TACE plus sorafenib target?
Related
- Drug class: All Combination therapy (locoregional procedure + multi-kinase inhibitor) drugs
- Target: All drugs targeting VEGFR, PDGFR, RAF kinases (sorafenib component)
- Manufacturer: Guangxi Medical University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hepatocellular carcinoma (HCC), intermediate to advanced stage
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing