Clinical trial · Interventional
Phase II of Lenvatinib Plus PD-1 Antibody for Advanced HCC
Phase II of Lenvatinib Plus Programmed Cell Death 1 Antibody for Advanced Hepatocellular Carcinoma
NCT03746249CI-TRIAL-00038194withdrawnPhase 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): No participants enrolled
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody in patients with advanced hepatocellular carcinoma (HCC)
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 |
| PD-1 antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenvatinib Plus PD-1
- description
- Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- interventionNames
- Drug: Lenvatinib
- Drug: PD-1 antibody
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 12 months
- description
- PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. * Barcelona clinic liver cancer-stage C * Eastern Cooperative Oncology Group performance status of 0 to 2 * with no previous treatment * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * The following laboratory parameters: * Platelet count ≥ 75,000/μL * Hemoglobin ≥ 8.5 g/dL * Total bilirubin ≤ 30mmol/L * Serum albumin ≥ 30 g/L * ASL and AST ≤ 5 x upper limit of normal * Serum creatinine ≤ 1.5 x upper limit of normal * INR ≤ 1.5 or PT/APTT within normal limits * Absolute neutrophil count (ANC) \>1,500/mm3 * Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
References
Publications (0)
Data not yet available
No reference posted for this study.