Floatz Rating
BB69/100
Confidence
Indicative
Sponsor
Haibo Shao
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
70High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07557914CT.gov Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes | — | Not Yet Recruiting | — | — | — |
NCT07584018CT.gov The DoHAICs Study Expansion Phase | — | Not Yet Recruiting | — | — | — |
NCT07363356CT.gov Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer | — | Not Yet Recruiting | — | — | — |
NCT07351513CT.gov A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma | — | Not Yet Recruiting | — | — | — |
NCT07180459CT.gov The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study | — | Not Yet Recruiting | — | — | — |
NCT07157306CT.gov Gecacitinib Combined With Donafenib and PD-1 Inhibitor as Immune Rechallenge Therapy for Unresectable Hepatocellular Carcinoma | — | Not Yet Recruiting | — | — | — |
NCT06812039CT.gov HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence | — | Recruiting | — | — | — |
NCT06646198CT.gov TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension | — | Recruiting | — | — | — |
NCT06609876CT.gov Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC | — | Recruiting | — | — | — |
NCT06581315CT.gov Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma | — | Recruiting | — | — | — |
Show 22 more trialsShow fewer
NCT06496815CT.gov Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy | — | Not Yet Recruiting | — | — | — |
NCT06512467CT.gov Donafenib Combine With Sintilimab and HAIC in Neoadjuvant of Resectable Hepatocellular Carcinoma | — | Not Yet Recruiting | — | — | — |
NCT06498622CT.gov Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab | — | Recruiting | — | — | — |
NCT06233994CT.gov A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma | — | Unknown | — | — | — |
NCT06244225CT.gov HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma | — | Recruiting | — | — | — |
NCT04962958CT.gov Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery | — | Unknown | — | — | — |
NCT05576909CT.gov Donafenib Combined With Hepatic Artery Chemoembolization for Perioperative Treatment of Liver Transplantation | — | Unknown | — | — | — |
NCT05545124CT.gov Study of Donafenib Combined With Tislelizumab in the Adjuvant Treatment of Primary HCC With High Risk of Recurrence | — | Unknown | — | — | — |
NCT05493332CT.gov HAIC Combined With Donafenib Tosilate and Toripalimab for Unresectable HCC | — | Unknown | — | — | — |
NCT05507632CT.gov Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma | — | Active Not Recruiting | — | — | — |
NCT05205629CT.gov A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC | — | Unknown | — | — | — |
NCT05717738CT.gov Combined TACE, TKI/Anti-VEGF and ICIs as Conversion Therapy for Advanced Hepatocellular Carcinoma | — | Recruiting | — | — | — |
NCT05171166CT.gov Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial. | — | Terminated | — | — | — |
NCT05162352CT.gov Donafenib Plus Sintilimab for Advanced HCC | — | Completed | — | — | — |
NCT05161143CT.gov Donafenib Combined With TACE as Adjuvant Therapy of Patients With Hepatocellular Carcinoma | — | Unknown | — | — | — |
NCT05166772CT.gov Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）in the First-line Treatment of Unresectable Hepatocellular Carcinoma | — | Unknown | — | — | — |
NCT04605185CT.gov Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma | — | Unknown | — | — | — |
NCT04503902CT.gov Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma | — | Unknown | — | — | — |
NCT04418401CT.gov Study on the Safety and Efficacy of Donafinib Combined With Anti-PD-1 Antibody as Adjuvant Therapy for HCC Patients | — | Completed | — | — | — |
NCT05713994CT.gov Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma | — | Recruiting | — | — | — |
NCT02645981CT.gov Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma | — | Completed | — | — | — |
NCT02229071CT.gov Safety and Efficacy of Donafenib in Patients With Advanced Hepatocellular Carcinoma | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Hepatocellular Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Donafenib (this asset) | Haibo Shao | Approved | BB · 69 |
| Adefovir | Bukwang Pharmaceutical | P4 | BBB |
| Huaier Granule | Tongji Hospital | P4 | BBB |
| Fluorouracilum | Li Qiang | P4 | BBB |
| Oxaliplatin | Li Qiang | P4 | BBB |
| Theprubicin | RWTH Aachen University | P4 | BB |
| Adriamycin | VA Office of Research and Development | P4 | BB |
| nrt6003 | Second Affiliated Hospital of Guangzhou Medical University | P3 | BB |
| Epirubicin | Fudan University | P4 | BB |
+42 more in the Hepatocellular Carcinoma cohort
Other indications for Donafenib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Colorectal Cancer | — | P3 | B · 59 |
| Digestive System Neoplasm | — | P2 | CCC · 55 |
| Chemotherapy-Induced Toxicity | — | P2 | CCC · 55 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Donafenib in Hepatocellular Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 11, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/donafenib-hepatocellular-carcinoma
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