Double attack on liver tumors: radiotherapy plus chemoembolization
NCT ID NCT01300143
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers test whether adding high-dose radiotherapy to standard chemoembolization slows tumor growth better than chemoembolization alone in adults with hepatocellular carcinoma. Participants have liver tumors up to 9 cm that cannot be removed by surgery or treated with percutaneous therapy. One group receives chemoembolization alone, while the other receives one chemoembolization session followed by radiotherapy. The trial measures time until tumors progress on scans, along with side effects and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of transarterial chemoembolization (TACE) with drug-eluting beads and high-dose conformational radiotherapy
- What this could lead to
- If it works, this could offer a stronger way to slow liver cancer in people who cannot have surgery or percutaneous treatment.
- What could go wrong
- This is a mid-stage trial, so the combination may not outperform chemoembolization alone or may cause more side effects. Results may not apply to all liver cancer patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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126 people
The number who actually took part.
- Started
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Jun 2011
- Finished
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Oct 2018
- 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 years and older
- 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: * Age ≥ 18 years of age * ECOG 0-1 * life expectancy ≥ 6 months * Histologically proven hepatocellular carcinoma or proven according to radiological and biochemical criteria (EASL-AASLD) in cirrhotic patients * Maximum lesion size ≤ 9 cm * Non-eligible for surgery or percutaneous therapy * Premature Child-Pugh A or B (7 points for the Child-Pugh score) * AST and ALT \< 7 x UNL * Technical possibility of conformational external radiotherapy * Technical possibility of TACE * All the tumor mass must be able to be treated by TACE * Written consent signed by the patient * Patients affiliated to a social security system Exclusion Criteria: * Metastatic illness * Minimal lesion size ≤ 5 mm * Non controlled viral replication B * History of radiotherapy at abdominal level * Subjects capable of procreating without efficient contraception * pregnancy or nursing female patient * Contraindication of TACE or external conformational radiotherapy * Any other concomitant experimental treatment * Contraindication of Doxorubicin * Patients who are unable to respect enslaving respiratory constraints if used by sites * Patients who are unable to understand information and to follow protocol instructions
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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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AP-HP Henri Mondor
Créteil, France
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AP-HP Paul Brousse Villejuif
Paris, France
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CH Avignon
Avignon, France
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CHD les Oudairies
La Roche-sur-Yon, France
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CHR Orléans
Orléans, France
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CHR de Lille Hôpital Claude Huriez
Lille, France
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CHU Amiens
Amiens, France
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CHU Dijon
Dijon, France
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CHU Nantes
Nantes, France
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CHU d'Angers
Angers, France
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CHU de Bordeaux
Bordeaux, France
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CHU de Lyon
Lyon, France
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CHU de Nancy Hôpital Brabois
Nancy, France
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CHU de Reims
Reims, France
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Centre Eugene Marquis
Rennes, France
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Hôpital Tenon
Paris, France
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Institut Sainte Catherine
Avignon, France
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La Pitié-Salpétrière
Paris, France
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