Clinical trial · Interventional
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC
TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Patients With Potentially High Recurrence Risk After Liver Cancer Resection: a Prospective, Randomized, Controlled Clinical Study
NCT05250843CI-TRIAL-00070475unknownPhase 2 / Phase 3ClinicalTrials.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)
The purpose of the study is to observe the effect of TACE/HAIC combined with lenvatinib and sintilimab as a neoadjuvant therapy before liver resection in preventing the recurrence in high-risk patients with 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| liver resection | Procedure | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
| TACE/HAIC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE/HAIC and Lenvatinib and PD-1(Sintilimab) before liver resection
- description
- For patients staged BCLC B/C,TACE/HAIC combined with Lenvatinib and Sintilimab will be conducted as neoadiuvent therapy before liver resection
- interventionNames
- Procedure: TACE/HAIC
- Drug: Lenvatinib
- Drug: Sintilimab
- type
- ACTIVE_COMPARATOR
- label
- Direct surgery group
- description
- After being diagnosed with hepatocellular carcinoma, surgery will be immediately performed.
- interventionNames
- Procedure: liver resection
Primary outcomes (1)
- measure
- Recurrence-free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) Age 18-70 years old, gender is not limited. * 2)The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL). * 3)Patients must have at least one tumor lesion that can be accurately measured. * 4)Conform to any of the following criteria (1) multiple nodules \>3; (2) ≥2 nodules, any of which is \>3 cm; (3) invasion of the portal vein or hepatic vein. * 5)According to the 2022 edition of the Chinese guidelines for the diagnosis and treatment of primary liver cancer, one-stage liver cancer resection is feasible after evaluation by the liver cancer surgery expert group * 6)No previous anti-HCC treatment. * 7)Eastern Co-operative Group performance status 2 or less. * 8)Liver function: Child's A or B (score \< 7). Exclusion Criteria: * 1)Patients with definite tumor thrombus and distant metastasis in the main portal vein and inferior vena cava; * 2\) Allergy to the components of intervention-related drugs such as lipiodol and chemotherapeutic drugs; * 3\) Local treatment (including intervention, surgery, ablation, etc.) and systemic treatment (chemotherapy, targeted drugs and immune checkpoint inhibitors, etc.) for liver cancer within the past 2 months
References
Publications (0)
Data not yet available
No reference posted for this study.