Clinical trial · Interventional
Phase II Study of Concurrent Lenvatinib and Radiotherapy for Advanced HCC
Phase II Study of Concurrent Lenvatinib and Intensity-modulated Radiotherapy (IMRT) for 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)
This is a single-arm, open-label study performed at our hospital, patients with progression hepatocellular carcinoma (HCC) met inclusion criteria will be enrolled. Patients received oral lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients\<60kg ) before local radiotherapy 4 weeks, large lesions were treated with IMRT for 40-60gy / 20-30f. Combined therapy will be taken until unacceptable treatment-related toxicities occurred or disease progression.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lenvatinib | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenvatinib and IMRT
- description
- Concurrent Lenvatinib and IMRT, followed Lenvatinib maintenance for advanced hepatocellular carcinoma with portal vein or hepatic vein tumor thrombosis or lymph node involved
- interventionNames
- Radiation: concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance
Primary outcomes (1)
- measure
- MST
- timeFrame
- 24 months
- description
- Median Survival Time (MST) was defined as the duration from the date of patient recruited to the date of death from any cause
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- Assessment in 1 to 3 months after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients had an HCC diagnosis confirmed either histologically or clinically according to the Chinese Society of Clinical Oncology guidelines for primary liver cancer 2019 version; 2. Aged ≥18 years and \<80 years; 3. ECOG 0-1; 4. Live-GTV volume \> 700ml; 5. BCLC stage C, HCC with portal vein or hepatic vein tumor thrombosis or lymph node involved (LN involved can be included one treatment planning); 6. Estimated life expectancy should be more than 3 months; 7. Patients with lung and / or bone metastases can be enrolled if those metastases couldn't effect the patients' life and quality of life within 3 months; 8. Child-Pugh Score A5,A6,B7; 9. Liver function: ALT is less than 1.5 times of the upper limit of normal; ALT is less than 0.5 times of the upper limit of normal, AST can be less than 6 times of the upper limit of normal, excluding the elevation of AST caused by heart infarction; ALT is 0.5 to 1.5 times of the upper limit of normal, AST is less than 1.5 times of the upper limit of normal; 10. ECG examination showed no obvious abnormality, no obvious cardiac dysfunction; 11. Renal function: CRE and BUN were within 1.5 times of the upper limit of normal value; 12. Blood routine: HB ≥ 80g / L, ANC ≥ 1.0 × 109 / L, PLT ≥ 40 × 109 / L; 13. Coagulation function: no bleeding tendency; 14. Informed and voluntarily participated in the study and signed informed consent. Exclusion Criteria: 1. Currently in the process of other clinical trials within recently four weeks; 2. Previous abdominal radiotherapy and liver transplantation; 3. Patients with severe chronic diseases of heart, kidney, liver and other important organs; 4. Pregnant or lactating women; 5. Suspected or indeed drug abusers, drug abusers and alcoholics; 6. Allergic to lenvatinib or other treatments. 7. Severe mental or nervous system disorders affecting informed consent and / or expression or observation of adverse reaction
References
Publications (0)
Data not yet available