Clinical trial · Interventional
Study of Tocilizumab in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transarterial Chemoembolization (TACE)
Phase IB/II Study of Tocilizumab in Patients With Hepatocellular Carcinoma (HCC) Undergoing Transarterial Chemoembolization (TACE)
NCT02997956CI-TRIAL-00027157withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding issues
Summary
Brief summary (as posted)
This is a phase IB study design planned to identify the MTD (Maximum Tolerated Dose) of Tocilizumab in HCC (Hepatocellular Carcinoma) patients followed by a phase II design whereupon the primary objective will be median progression free survival (PFS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tocilizumab | Drug | — | UNRESOLVED |
| Transcatheter Arterial Chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tocilizumab
- description
- Participants will receive Tocilizumab (ACTEMRA®) at 4, 6, or 8 mg/kg IV dose escalation on days 1, 29 and 57. The first part of the trial will be Phase Ib and will enroll 18 participants. Participants will receive TACE on day 1 and Tocilizumab at dose level 1, 2, or 3 on days 1, 29 and 57. Maximum tolerated dose (MTD) of Tocilizumab will be determined. The second part of the trial will be a Phase II and will enroll 50 subjects. Participants will receive TACE on day 1 and Tocilizumab at the MTD on days 1, 29 and 57.
- interventionNames
- Drug: Tocilizumab
- Procedure: Transcatheter Arterial Chemoembolization
Primary outcomes (2)
- measure
- Maximum Tolerated Dose of Tocilizumab
- timeFrame
- 84 Days Post Treatment
- description
- The MTD is defined as the dose of Tocilizumab that induces dose-limiting toxicity in 20% of subjects or less when added to TACE. Patients must complete 84 days of treatment before the dose can be escalated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic evidence of HCC, Barcelona-Clinic Liver Cancer (BCLC) stage B * FFPE (Fixed-paraffin Embedded) tumor tissue (two cores preferred) for biomarker analysis * Prior radioembolization, local ablative therapies (radiofrequency, microwave or cryoablation), radiation (external beam or stereotactic), or hepatic resection permitted if completed ≥ 4 weeks prior to study enrollment and if patient has recovered with ≤ grade 1 toxicity and if untreated measurable disease is present. * Radiographically measurable disease by mRECIST in at least one site not previously treated by local therapies. * Must not be receiving treatment with other investigational agents and must not have received any other investigational agent's ≤ 4 weeks prior to registration. * Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Required lab and acceptable range criteria. * Women of child-bearing potential and men must agree to use 2 methods of adequate contraception. * No contraindications to TACE therapy * Child-Pugh Score A-B * Ability to understand and the willingness to sign a written informed consent, and the willingness to comply with the requirements of the protocol. * Life expectancy greater than 3 months. * Adequate baseline organ and marrow function Exclusion Criteria: * History of hepatitis B * Women must not be pregnant or breastfeeding * Presence of other malignancies * Active or history of Tuberculosis * Patients with known HIV positive status * Conditions with impaired immunity or on immunosuppressive medications such as oral steroids, calcineurin inhibitors, or anti-proliferative agents. * Must have no evidence of significant, uncontrolled concomitant diseases * Must have no ongoing or active, uncontrolled infections
References
Publications (0)
Data not yet available
No reference posted for this study.