Clinical trial · Interventional
Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma
Efficacy and Safety of Modified Hepatic Artery Infusion Chemotherapy (TOMOX-HAIC) in Combination With Sintilimab and Bevacizumab Biosimilar for the First-line Treatment of Advanced Hepatocellular Carcinoma: a Prospective, Single-arm, Phase II Clinical Study
NCT06285019CI-TRIAL-00074538unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Sintilimab | Drug | Sintilimab | ALIAS |
| TOMOX-HAIC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination therapy
- description
- TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar
- interventionNames
- Procedure: TOMOX-HAIC
- Drug: Sintilimab
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- 24 months
- description
- ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. and mRECIST
Secondary outcomes (6)
- measure
- disease control rate (DCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial. * Males or unpregnant females who age ≥ 18 years, ≤75 years. * The investigator believes the patient is capable of complying with the study protocol. * Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma. * is not a candidate for radical surgery * not received previous systemic treatment * patients must have at least one measurable lesion (RECIST 1.1) * ECOG PS：0-1, 14 days before enrollment * Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment Exclusion Criteria: * Prior history of other malignant tumors * Current or prior immunodeficiency disorders or autoimmune diseases * Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding * Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study * Conditions considered unsuitable for inclusion by researchers
References
Publications (0)
Data not yet available
No reference posted for this study.