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NCT04194775
A Study of Nofazinlimab (CS1003) in Subjects With Advanced Hepatocellular Carcinoma
Phase 3 trial testing Nofazinlimab (CS1003)+Lenvatinib in Hepatocellular Carcinoma in 534 participants. Participants enrolled and being followed up; not accepting new ones.
18 June 2025
Quick facts
| Lead sponsor | CStone Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 534 |
| Start date | 13 December 2019 |
| Primary completion | 18 June 2025 |
| Estimated completion | 30 September 2026 |
| Sites | 74 locations across Italy, Taiwan, Poland, China, United States, Spain |
Drugs / interventions tested
- Nofazinlimab (CS1003)+Lenvatinib — full drug profile →
- Nofazinlimab (CS1003) Placebo+Lenvatinib
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
CStone Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, double-blind, randomized, phase III study to investigate the efficacy and safety of Nofazinlimab (CS1003) in combination with lenvatinib and placebo in combination with lenvatinib in the treatment of subjects with no prior systemic treatment and with unresectable advanced hepatocellular carcinoma (HCC). Subjects cannot be eligible for locoregional therapy. In this study, Nofazinlimab (CS1003) (or placebo) and lenvatinib are both considered as the study treatment while Nofazinlimab (CS1003) (or placebo) is the investigational product of and lenvatinib is selected as the basic treatment for HCC.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging Therapies for Hepatocellular Carcinoma (HCC).
Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798 -
Antibodies to watch in 2023.
Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410 -
Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets.
Luo XY, Wu KM, He XX. · · 2021 · cited 144× · PMID 34006331 · DOI 10.1186/s13046-021-01968-w -
Hepatocellular carcinoma: signaling pathways and therapeutic advances.
Zheng J, Wang S, Xia L, Sun Z, et al · · 2025 · cited 142× · PMID 39915447 · DOI 10.1038/s41392-024-02075-w -
Antibodies to watch in 2025.
Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538 -
Therapy of Primary Liver Cancer.
Feng M, Pan Y, Kong R, Shu S. · · 2020 · cited 71× · PMID 32914142 · DOI 10.1016/j.xinn.2020.100032 -
Biomarkers and prognostic factors of PD-1/PD-L1 inhibitor-based therapy in patients with advanced hepatocellular carcinoma.
Zhang N, Yang X, Piao M, Xun Z, et al · · 2024 · cited 69× · PMID 38355603 · DOI 10.1186/s40364-023-00535-z -
Glucose Metabolism and Oxidative Stress in Hepatocellular Carcinoma: Role and Possible Implications in Novel Therapeutic Strategies.
Mossenta M, Busato D, Dal Bo M, Toffoli G. · · 2020 · cited 60× · PMID 32585931 · DOI 10.3390/cancers12061668
Verify or expand the search:
- PubMed search for NCT04194775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
- NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
- NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
- NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
Other CStone Pharmaceuticals trials
Trials by the same sponsor.
- NCT05381753 — Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World · completed
- NCT05279300 — A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas · Phase 1 · recruiting
- NCT04421352 — Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients · Phase 1 · completed
- NCT04233060 — A Study of CS3005 in Advanced Solid Tumors · Phase 1 · completed
- NCT04162301 — A Study of CS3002 in Subjects With Advanced Solid Tumors · Phase 1 · terminated
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 NCT04194775 (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 CStone Pharmaceuticals
- Last refreshed: 11 December 2025
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/NCT04194775.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing