Clinical trial · Observational
Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma
The Effectiveness and Safety of Lenvatinib Combined Anti-programmed Death Immunotherapy for the Advanced Hepatocellular Carcinoma
- 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)
For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anti-PD1 Antibody | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Keytruda | Drug | Pembrolizumab | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Opdivo | Drug | Nivolumab | ALIAS |
| Sintilimab | Drug | Sintilimab | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-Free-Survival(PFS)
- timeFrame
- 24 months
- description
- Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause
- measure
- Overall survival (OS)
- timeFrame
- 24 months
- description
- OS is the length of time from the date of randomization until death from any cause.
Secondary outcomes (3)
- measure
- Objective response rate (ORR)
- timeFrame
- 6 months
- description
- ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery; 2. age between 18 and 75 years; 3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B. 4. Previous use of any systemic therapy but intolerant, impotent or drug resistant. 5. Child-Pugh class A or B; 6. Eastern Cooperative Group performance status (ECOG) score of 0-2; 7. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 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 8. Prothrombin time ≤18s or international normalized ratio \< 1.7. 9. Ability to understand the protocol and to agree to and sign a written informed consent document. Exclusion Criteria: 1. Cholangiocellular carcinoma (ICC); 2. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded; 3. The survival or patients less than 3 months. 4. Serious medical comorbidities. 5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. Known history of HIV 7. History of organ allograft 8. Known or suspected allergy to the investigational agents or any agent given in association with this trial. 9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. Evidence of bleeding diathesis. 11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
References
Publications (0)
Data not yet available