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NCT05262959
A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC
Phase 2 trial testing Donafenib, PD-1 in Donafenib in 30 participants. Completed in 30 May 2024.
30 April 2024
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 December 2021 |
| Primary completion | 30 April 2024 |
| Estimated completion | 30 May 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Donafenib, PD-1 — full drug profile →
- TACE
Conditions studied
- Donafenib — all drugs for Donafenib →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 75, any sex, with Donafenib. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Significance of Transarterial Chemo(Embolization) Combined With Tyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma in the Era of Systemic Therapy: A Systematic Review.
Ke Q, Xin F, Fang H, Zeng Y, et al · · 2022 · cited 40× · PMID 35677059 · DOI 10.3389/fimmu.2022.913464 -
Recent Updates on the Development of Deuterium-Containing Drugs for the Treatment of Cancer.
Belete TM. · · 2022 · cited 28× · PMID 36217450 · DOI 10.2147/dddt.s379496 -
Clinical benefits of transarterial chemoembolization combined with tyrosine kinase and immune checkpoint inhibitors for unresectable hepatocellular carcinoma.
Han F, Wang XH, Xu CZ. · · 2024 · cited 2× · PMID 39072161 · DOI 10.4251/wjgo.v16.i7.3308 -
T-cell Receptor Repertoire Analysis in the Context of Transarterial Chemoembolization Synergy with Systemic Therapy for Hepatocellular Carcinoma.
Li J, Zhang Y, Hu L, Ye H, et al · · 2025 · cited 1× · PMID 39801788 · DOI 10.14218/jcth.2024.00238 -
Unveiling the Power of Deuterium in Drug Discovery: A Comprehensive Overview
Lele M, Manchare A, Parit S, Gholap A, et al · · 2026
Verify or expand the search:
- PubMed search for NCT05262959
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Donafenib
Currently open trials in the same condition.
- NCT06609876 — Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC · NA · recruiting
Other Shanghai Zhongshan Hospital trials
Trials by the same sponsor.
- NCT07353476 — Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC · Phase 2 · not yet recruiting
- NCT07508956 — Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric · Phase 3 · not yet recruiting
- NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
- NCT07531368 — BBAP With CS Mapping Guidance · NA · not yet recruiting
- NCT07501104 — Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05262959 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 13 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05262959.
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