Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06397235

Reclutamento in corso

DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

Interventistico

Fase 2

The Second Affiliated Hospital of Guangzhou Medical University

Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Ultimo Aggiornamento: 25 marzo 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).

Mostra Descrizione Dettagliata

Categoria di Trattamento

Altri Farmaci

Mutazioni richieste

Nessuno

Studio Iniziato

1 maggio 2024

Ultimo Aggiornamento dello Sponsor

25 marzo 2025

Completamento Stimato

30 aprile 2027

Contatto dello studio

Idoneità

Criteri di Inclusione

* HCC confirmed by histology/cytology or diagnosed clinically.

* At least one measurable intrahepatic target lesion.

* The largest tumor size > 7 cm.

* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.

* Child-Pugh score 5-7.

* ECOG performance status ≤ 1.

* Adequate organ and hematologic function with platelet count ≥75×10^9/L, leukocyte >3.0×10^9/L, Neutrophil count ≥1.5×10^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.

Criteri di Esclusione

* Macrovascular invasion or extrahepatic metastasis.

* Diffuse HCC.

* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.

* Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.

* Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.

* History of other malignancies.

* Uncontrollable infection.

* History of HIV.

* Gastrointestinal bleeding within 30 days, or other bleeding> CTCAE grade 3.

* History of organ or cells transplantation.

* Pregnant or lactating patients.

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Dettagli del Disegno

AllocazioneRandomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare130

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, in order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The RALOX-based regimen is intra-arterially administered. During follow-up, the treatment will be repeated on demand (about 4-week interval) based on the evaluation of the follow-up laboratory and imaging examination.

Interventi:

DEB-TACE+HAIC
DEB-TACE

Misure di Esito

Misure di Esito Primarie

Progression free survival (PFS)3 years

The time from date of randomization until the first occurrence of disease progression (according to mRECIST) or death due to any cause, whichever occurs first.

Misure di Esito Secondarie

Objective response rate (ORR)3 years

The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.

Disease control rate (DCR)3 years

The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.

Overall survival (OS)4 years

The time from date of randomization to death due to any cause.

Adverse Events (AEs)3 years

Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.

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Siti dello Studio

Questo studio ha 1 sito

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, CN

Nome:Kangshun Zhu, Dr.

Email:zhksh010@126.com

Telefono:+86-20-34156205

In fase di reclutamento

Guangzhou, Guangdong, 510260 CN

The Second Affiliated Hospital of Guangzhou Medical University

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