Fibrolamellar hepatocellular carcinoma clinical trials
The registry lists 20 studies for Fibrolamellar hepatocellular carcinoma across more than 10 countries. 8 are recruiting or about to start. 13 of them are mainly about Fibrolamellar hepatocellular carcinoma (how this is decided). Per ClinicalTrials.gov, last updated 2026-10-30.
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· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
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Who runs them
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (4) · Children's Oncology Group (2) · University Hospital Tuebingen (2) · Memorial Sloan Kettering Cancer Center (2) · Agenus Inc. (1) · Instituto do Cancer do Estado de São Paulo (1) · National Cancer Institute (NCI) (1) · Charite University, Berlin, Germany (1)
What is being tested here
Drugs under test in Fibrolamellar hepatocellular carcinoma studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| Sirpiglenastat | 1 | 0 | 2 |
| Cyclophosphamide | 1 | 0 | 2 |
| Atezolizumab | 1 | 0 | 1 |
| Sorafenib | 1 | 0 | 1 |
| Bevacizumab | 1 | 0 | 1 |
| Pembrolizumab | 1 | 0 | 1 |
| Nivolumab | 0 | 0 | 1 |
| Cisplatin | 0 | 1 | 1 |
| Botensilimab | 0 | 0 | 1 |
| Cobolimab | 0 | 0 | 1 |
Drug classes tested here Immune checkpoint inhibitors 2 open · Angiogenesis inhibitors 1 open
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 3, phase 3 first
- Mar 2027Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery · Phase 3 · Children's Oncology Group
- Jan 2027Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma · Allison O'Neill, MD
- Jul 2027Agnostic Therapy in Rare Solid Tumors · Instituto do Cancer do Estado de São Paulo
Who these studies take
Of the 7 Fibrolamellar hepatocellular carcinoma studies recruiting now, 5 (71%) set no upper age limit and 2 (29%) stop at 75 or younger. 5 (71%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 0 (0%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 2 (29%) | 2 (29%) |
| 18 | 7 (100%) | 7 (100%) |
| 30 | 7 (100%) | 7 (100%) |
| 40 | 5 (71%) | 5 (71%) |
| 50 | 5 (71%) | 5 (71%) |
| 65 | 5 (71%) | 5 (71%) |
| 75 | 5 (71%) | 5 (71%) |
| 85 | 5 (71%) | 5 (71%) |
Across all 20 studies, recruiting or not: 30% stop at 75 or younger and 30% at 65; 60% take children; 0% are for women only and 0% for men only; 0% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
What changed recently
From the registry's own updates since Oct 15, 2026.
Stopped1
- KAT-101 in Subjects With Hepatocellular Carcinoma (HCC)TerminatedOct 27, 2026NCT05603572
Studies
Recruiting first, then most recently updated. Showing 20 of 20. search them.
- A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)RecruitingNCT07430202Phase 11 country
- Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACARecruitingNCT06789198Phase 11 country
- Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor PatientsRecruitingNCT05468359Phase 1/21 country
- Checkpoint Inhibition In Pediatric Hepatocellular CarcinomaRecruitingNCT04134559Phase 21 country
- DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular CarcinomaRecruitingNCT04248569Phase 11 country
- A French Multicenter Observational Retrospective Study of Rare Primary Liver CancersRecruitingNCT065416521 country
- FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint InhibitionRecruitingNCT05937295Phase 11 country
- Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor BoardsNot yet recruitingNCT05681949Not applicable1 country
- KAT-101 in Subjects With Hepatocellular Carcinoma (HCC)TerminatedNCT05603572Phase 1/21 country
- DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)Active, not recruitingNCT06027086Phase 1/21 country
- Agnostic Therapy in Rare Solid TumorsActive, not recruitingNCT06638931Phase 21 country
- Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After SurgeryActive, not recruitingNCT03533582Phase 36 countries
- Testing the Addition of an Anti-cancer Drug, DT2216, to the Usual Chemotherapy Treatment for Relapsed or Refractory Solid Tumors and Fibrolamellar CarcinomaSuspendedNCT06620302Phase 1/21 country
- Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced CancerActive, not recruitingNCT03860272Phase 12 countries
- A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With CancerActive, not recruitingNCT06521567Phase 1/26 countries
- Registry to Collect Health Information Related to Fibrolamellar CancerCompletedNCT048745191 country
- Sapanisertib and Ziv-Aflibercept in Treating Patients With Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by SurgeryCompletedNCT02159989Phase 11 country
- Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)CompletedNCT01642186Phase 21 country
- Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Hepatocellular Carcinoma (HCC)WithdrawnNCT02702960Phase 21 country
- Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar CarcinomaTerminatedNCT01215565Phase 21 country