Clinical trial · Interventional
Association of Conformational High-dose Radiotherapy and of Hyperselective Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma
NCT01300143CI-TRIAL-00055674TACERTEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
Indication : Hepatocellular carcinoma, maximum size 9 cm, with single or multiple nodes whose total tumor mass can technically be irradiated, non-resectable, and not a candidate for percutaneous therapy with recommended treatment via hyperselective transarterial chemoembolisation (TACE).
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE | Other | — | UNRESOLVED |
| TACE+ RTC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TACE
- description
- Patients will be treated by 2 or 3 cures of hyperselective TACE. The first one at week 0 and the second one at week 8. If required, a third cure of TACE could be done at week16.
- interventionNames
- Other: TACE
- type
- EXPERIMENTAL
- label
- TACE + RTC
- description
- Patients will be treated by one cure of TACE at week 0. Then, patients will be treated within two weeks by external conformational radiotherapy of 54 grey fractioned in 18 sessions during 3-4 weeks.
- interventionNames
- Other: TACE+ RTC
Primary outcomes (1)
- measure
- Time of tumor progression radiologically (CTScan) measured by mRECIST (Modified Response Evaluation Criteria In Solid Tumor).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFeray C, Campion L, Mathurin P, Archambreaud I, Mirabel X, Bronowicki JP, Rio E, Perret C, Mineur L, Oberti F, Touchefeu Y, Gournay J, Regnault H, Edeline J, Rode A, Hillion P, Blanc JF, Khac EN, Azoulay D, Luciani A, Preglisasco AG, Faurel-Paul E, Auble H, Mornex F, Merle P. TACE and conformal radiotherapy vs. TACE alone for hepatocellular carcinoma: A randomised controlled trial. JHEP Rep. 2023 Jan 29;5(4):100689. doi: 10.1016/j.jhepr.2023.100689. eCollection 2023 Apr. PMID 36937990