Last reviewed · How we verify
hepatic artery infusion chemotherapy
hepatic artery infusion chemotherapy is a Small molecule drug developed by RenJi Hospital. It is currently in Phase 1 development. Also known as: HAIC.
Hepatic artery infusion chemotherapy is used to treat conditions such as neuroendocrine tumors, liver metastases, and hepatocellular carcinoma, particularly in patients who are potentially resectable. The treatment involves delivering medication directly to the liver via the hepatic artery, often using radiolabeled somatostatin analogs or oligonucleotides that target specific molecular pathways.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | hepatic artery infusion chemotherapy |
|---|---|
| Also known as | HAIC |
| Sponsor | RenJi Hospital |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- HAIC Plus Systemic Therapy as De-escalation Therapy Strategy for Biliary Tract Cancer (NA)
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (PHASE3)
- Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus (PHASE2)
- HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion
- Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial) (PHASE2)
- TACE Plus HAIC Combined With Regorafenib for Liver Metastasis of Colorectal Cancer Refractory to Standard Treatment Regimens (PHASE2)
- Impact of Emotional Status on Prognosis of Patients With BCLC Stage B/C Hepatocellular Carcinoma Undergoing Hepatic Arterial Infusion Chemotherapy Combined With Targeted and Immunotherapy
- Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma (PHASE2)
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:
- hepatic artery infusion chemotherapy CI brief — competitive landscape report
- hepatic artery infusion chemotherapy updates RSS · CI watch RSS
- RenJi Hospital portfolio CI
Frequently asked questions about hepatic artery infusion chemotherapy
What is hepatic artery infusion chemotherapy?
Who makes hepatic artery infusion chemotherapy?
Is hepatic artery infusion chemotherapy also known as anything else?
What development phase is hepatic artery infusion chemotherapy in?
Related
- Manufacturer: RenJi Hospital — full pipeline
- Also known as: HAIC
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing