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NCT04611165: Nextrah
Concurrent Nivolumab and External Beam Radiation Therapy for Patients With Advanced HCC
Completed
Phase 2
Last updated 22 May 2025
What this trial tests
Phase 2 trial testing Nivolumab in Advanced Hepatocellular Carcinoma in 50 participants. Completed in 15 December 2023.
Timeline
15 November 2019
Primary endpoint
30 December 2022
30 December 2022
15 December 2023
Quick facts
| Lead sponsor | National Cancer Center, Korea |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 15 November 2019 |
| Primary completion | 30 December 2022 |
| Estimated completion | 15 December 2023 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Nivolumab (nivolumab) — full drug profile →
Conditions studied
- Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →
Sponsor
National Cancer Center, Korea
Who can join
20 and older, any sex, with Advanced Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate the efficacy and safety of nivolumab for patients with advanced HCC undergoing EBRT
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The liver cancer immune microenvironment: Therapeutic implications for hepatocellular carcinoma.
Donne R, Lujambio A. · · 2023 · cited 461× · PMID 35989535 · DOI 10.1002/hep.32740 -
Advances in radiotherapy and immunity in hepatocellular carcinoma.
Yang Y, Xiong L, Li M, Jiang P, et al · · 2023 · cited 37× · PMID 37542324 · DOI 10.1186/s12967-023-04386-y -
Concurrent nivolumab and external beam radiation therapy for hepatocellular carcinoma with macrovascular invasion: A phase II study.
Kim BH, Park HC, Kim TH, Koh YH, et al · · 2024 · cited 22× · PMID 38463541 · DOI 10.1016/j.jhepr.2023.100991 -
Radiotherapy as an immune checkpoint blockade combination strategy for hepatocellular carcinoma.
Lee BM, Seong J. · · 2021 · cited 19× · PMID 33776363 · DOI 10.3748/wjg.v27.i10.919 -
Radiation and Immune Checkpoint Inhibitors: Combination Therapy for Treatment of Hepatocellular Carcinoma.
Chami P, Diab Y, Khalil DN, Azhari H, et al · · 2023 · cited 13× · PMID 38069095 · DOI 10.3390/ijms242316773 -
Radiation therapy in the era of immune treatment for hepatocellular carcinoma.
Chen L, Zhang R, Lin Z, Tan Q, et al · · 2023 · cited 12× · PMID 36742293 · DOI 10.3389/fimmu.2023.1100079 -
Real-World Use of Immunotherapy for Hepatocellular Carcinoma.
Sara A, Ruff SM, Noonan AM, Pawlik TM. · · 2023 · cited 8× · PMID 37637511 · DOI 10.2147/por.s397972 -
Combination of Immunotherapy and Radiation Therapy in Gastrointestinal Cancers: An Appraisal of the Current Literature and Ongoing Research.
Kumar R, Kim J, Deek MP, Eskander MF, et al · · 2023 · cited 7× · PMID 37504333 · DOI 10.3390/curroncol30070473
Verify or expand the search:
- PubMed search for NCT04611165
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Advanced Hepatocellular Carcinoma
Currently open trials in the same condition.
- NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO- · Phase 3 · recruiting
- NCT07174570 — Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer · Phase 2 · recruiting
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- NCT06811116 — Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metasta · Phase 1, PHASE2 · recruiting
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Other National Cancer Center, Korea trials
Trials by the same sponsor.
- NCT07399561 — Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy · NA · not yet recruiting
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- NCT07171528 — Secondary Cytoreductive Surgery After Chemotherapy for Recurrent Epithelial Ovarian Cancer · Phase 2 · recruiting
- NCT07125924 — Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04611165 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 National Cancer Center, Korea
- Last refreshed: 22 May 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/NCT04611165.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing