Clinical trial · Interventional
TACE Combined With Lenvatinib and MWA in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
Prospective Single Arm Phase II Study of TACE Combined With Lenvatinib and MWA After Down-stage in the Treatment of Locally Advanced Large Hepatocellular Carcinoma
NCT05555316CI-TRIAL-00061039unknownPhase 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)
To explore the objective effectiveness and safety of TACE combined with Lenvatinib in the treatment of advanced liver cancer. After successful down-stage, radical microwave ablation was further performed.
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 |
|---|---|---|---|
| Liver Tumor | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE combined with Lenvatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE combined with Lenvatinib
- description
- Three days after the first TACE treatment, when the liver function was evaluated as grade A / B, Lenvatinib was taken orally, 8mg / day (body weight less than 60kg) or 12mg / day (body weight equal to or more than 60kg).
- interventionNames
- Drug: TACE combined with Lenvatinib
Primary outcomes (1)
- measure
- Down stage rate
- timeFrame
- 4 months
- description
- if the patient achieve any of these three criteria: ① the patient was downgraded from BCLC stage C to BCLC stage B (portal branch tumor thrombus was inactive, the focus was less than or equal to 7cm; or the focus did not invade the surrounding tissue after shrinking) or Milan standard (single tumor diameter was not more than 5cm or less than or equal to 3 tumors, and the maximum diameter was not more than 3cm, without vascular invasion). ② Liver function reaches child Pugh grade A or B; ③ The patient is in good health and can tolerate ablation.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18-75 years with hepatocellular carcinoma have an expected survival of at least 3 months; * Number of tumors ≤ 3; * Large hepatocellular carcinoma with tumor diameter ≥ 7 cm; * Patients without inferior vena cava tumor thrombus, portal vein tumor thrombus and cholangiocarcinoma thrombus; * Although there is arteriovenous fistula or arterioportal fistula, it can be completely blocked; * Child Pugh grade A or B of liver function; ECoG physical fitness score \< 2; * No bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment; * Leukocyte count ≥ 3.0 × 109/L; * Hemoglobin ≥ 8.5g/dl; * Platelet count ≥ 50 × 109/L; * The international normalized ratio of prothrombin time (INR) ≤ 2.3 or prothrombin time (PT) does not exceed the upper limit of normal control for 3 seconds; * Serum creatinine was less than 1.5 times of the upper limit of normal; * Patients and / or family members agree to join the clinical trial and sign the informed consent form Exclusion Criteria: * Diffuse hepatocellular carcinoma; * Portal vein tumor thrombus; * Combined with tumor thrombus of hepatic vein and inferior vena cava; * Patients with lymph node metastasis and extrahepatic distant metastasis; * The liver function was classified as child Pugh C and could not be improved by liver protection treatment; * Arteriovenous fistula or arterioportal fistula with ineffective intervention; * Uncorrectable coagulation dysfunction and obvious hemogram abnormalities, with obvious bleeding tendency; * Intractable massive ascites; * ECoG physical fitness score \> 2 points; * Combined with active infection, especially bile duct inflammation; * Serious heart, lung, kidney, brain and other important organ diseases; * Note: see attached table 1 for child Pugh classification of liver function; See attached table 2 for ECoG physical fitness score
References
Publications (0)
Data not yet available
No reference posted for this study.