Clinical trial · Interventional
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
NCT04042805CI-TRIAL-00050399unknownPhase 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 ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Sintilimab | Biological | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab Plus Lenvatinib
- description
- Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight \<60 kg) orally once a day (QD) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- interventionNames
- Biological: Sintilimab
- Drug: Lenvatinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 1 year after the last patient's enrollment
Secondary outcomes (4)
- measure
- Overall Survival
- timeFrame
- 2 years after the last patient's enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology * Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery * No previous systemic anticancer treatment or TACE treatment * Age ≥18 years * ECOG performance status: 0-1 * Child Pugh score≤7 * Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1 * Life expectancy ≥12 weeks. * Patients must be able to understand and willing to sign a written informed consent document Exclusion Criteria: * Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma * History of hepatic encephalopathy or liver transplantation * Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. * Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity * With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable. * Evidence of active pulmonary tuberculosis (TB). * Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) * History of allergic reactions to related drugs * Pregnant women, nursing mothers
References
Publications (0)
Data not yet available
No reference posted for this study.