Double attack on liver cancer: does adding RFA to TACE improve survival?
NCT ID NCT02435953
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tested whether adding radiofrequency ablation (RFA) to standard transarterial chemoembolization (TACE) improves outcomes for people with intermediate-stage liver cancer. 241 participants with 2-10 liver tumors were randomly assigned to receive either TACE alone or TACE followed by RFA. The study measured progression-free survival, overall survival, and tumor response rates to see if the combination is more effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TACE (chemoembolization) and RFA (radiofrequency ablation)
- What this could lead to
- If successful, combining TACE with RFA could improve survival and tumor control for people with intermediate-stage liver cancer compared to TACE alone.
- What could go wrong
- This is a completed phase 3 trial, but results may not apply to all patients. The combination may increase side effects or not show a clear benefit over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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241 people
The number who actually took part.
- Started
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May 2015
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Multiple HCC (2-3 lesions), largest lesion 3-7 cm in diameter, or multiple HCC (4-10 lesions), each ≤ 7 cm in diameter * No vascular invasion or etrahepatic metastases * Eastern Cooperative Oncology Group Performance Status 0 * Child-Pugh Stage A or B7 * Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to procedure: I.Adequate hematologic function: 1. WBC ≥ 4.0 x 109/L (stable, off any growth factor within 4 weeks of study drug administration) 2. Neutrophils ≥ 1.5 x 109/L (stable, off any growth factor within 4 weeks of study drug administration) 3. Platelets ≥ 60 x 109/L (transfusion to achieve this level is not permitted) 4. Hemoglobin ≥ 100 g/L (may be transfused to meet this requirement) II.Adequate hepatic function: 1. Serum Aspartate Aminotransferase (AST) ≤ 5×ULN 2. Serum Alanine Aminotransferase (ALT) ≤ 5×ULN 3. Serum total bilirubin ≤ 51.3 μmol/L 4. Serum albumin ≥ 2.8 g/dL III.Adequate coagulation function: a)prothrombin activity ≥ 40% IV.Adequate renal function: a)Serum creatinine \< 110 μmol/L Exclusion Criteria: * Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity \> grade 1 * Any contraindications for TACE/RFA procedure: I.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 40%) II.Renal failure / insufficiency requiring hemodialysis or peritoneal dialysis. III.Known severe atheromatosis IV.Known uncontrolled blood hypertension (\> 160/100 mmHg) V.Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy VI.Clinically significant third space fluid accumulation (i.e., ascites requiring tapping despite use of diuretic or pleural effusion that either required tapping or is associated with shortness of breath) * Evidence of hepatic discompensation (i.e., refractory ascites, esophageal or gastric variceal bleeding, or hepatic encephalophathy) * Patients with any other malignancies within the last 3 years before study start * History of HCC tumor rupture * Clinically significant (CTC grade 3 or 4) venous or arterial thrombotic disease within past 6 months * History of abdominal fistula, GI perforation, or intra-abdominal abscess within past 6 months prior to study treatment * Pregnant women or lactating women * Be allergic to pirarubicin, lobaplatin and iodized oil
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Minimally Invasive Interventional Division, Medical Imaging Center, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 500060, China
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Other studies related to the condition(s) this trial covers.
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