NCT04047173Befejeződött3. fázis

RFA Versus SBRT for Recurrent Small HCC

Radiofrequency Ablation Versus Stereotactic Body Radiotherapy for Recurrent Small Hepatocellular Carcinoma: a Randomized, Open-label, Controlled Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. jún. 17.

Rövid összefoglaló (regiszter, angolul)

Recurrence rate of hepatocellular carcinoma (HCC)after resection is as high as 65.0%-83.7%.The recurrence of HCC is the most important factor affecting prognosis. Reasonable and effective treatment of recurrent lesion can significantly improve the long-term treatment efficacy of HCC. The recurrent lesion is usually detected when it's small and is the best indication for local treatment. Local ablation therapy represented by radiofrequency ablation (RFA) is one of the main treatments for recurrent small HCC. Our previous study showed that for recurrent small HCC(≤5cm), RFA has the efficacy equivalent to re-excision, with the advantages of small trauma, quick recovery, low cost, and high quality of life. With the advancement of radiotherapy equipment and the development of precise radiotherapy technology, stereotactic radiotherapy (SBRT) has become one of the routine treatments for HCC, especially for small HCC. Retrospective controlled studies have shown that SBRT is similar to RFA in treating small HCC, and the local control rate may be better than RFA. This project is to conduct a prospective, open, randomized, controlled clinical study of RFA versus SBRT for the treatment of recurrent small hepatocellular carcinoma (single lesion ≤ 5 cm, without extra-hepatic metastasis or vascular invasion). The primary endpoint is local progression-free survival (LPFS), and secondary endpoints are progression-free survival (PFS), overall survival (OS), local control rate (LCR), and safety. Data analysis will be performed according to intention-to-treat (ITT) principles. Subgroup analyses will be conducted according to the predefined stratification factor (tumor diameter ≤ 2 cm vs. 2-5 cm) and other baseline characteristics. The results of these study will help to further improve the long-term treatment efficacy of HCC and establish a rational and effective treatment model for HCC.

Állapot (regiszter): Befejeződött
Fázis (regiszter): 3. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 166 (tényleges)
Első benyújtás: 2019. aug. 4.
Kezdés: 2019. aug. 12.
Elsődleges befejezés: 2024. ápr. 1.
Fő szponzor: Sun Yat-sen University
Betegségek: Máj- és epeúti rák
NCT-szám: NCT04047173

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 3. fázis
Bevont résztvevők: 166
2019. aug. 12. és az elsődleges befejezés (2024. ápr. 1.) között
1 helyszín, 1 országban
Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

Concomitant severe cardiac, pulmonary, renal, or other major organ dysfunction, severe infection or other comorbidities, unable to tolerate treatment;
Concomitantly receiving other anti-tumor therapy (including immunotherapy and targeted therapy);

Más betegség

History of other malignancies;
History of allergic reactions to relevant drugs;
History of organ transplantation;

Egyéb

Presence of extrahepatic metastasis or intrahepatic vascular invasion;
More than one recurrent lesion, or maximum diameter \> 5 cm;
During pregnancy or lactation;
Unable to undergo one of the treatments (RFA or SBRT);
Other factors that may affect patient enrollment and evaluation results;
Refusal to comply with the study protocol requirements for follow-up and refusal to sign the informed consent form.

Kiket keres a vizsgálat

Aged 18-75 years;
Diagnosed with HCC: The diagnosis of HCC will be confirmed according to the " Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition) " formulated by the National Health Commission of China and the Barcelona Clinic Liver Cancer (BCLC) strategy for prognosis prediction and treatment recommendation of the European Association for the Study of the Liver (EASL);
Recurrent small HCC: Single hepatocellular carcinoma ≤ 5 cm that recurs after previous curative resection or thermal ablation, with the recurrence time ≥ 3 months from resection/ablation, and without extrahepatic metastasis or vascular invasion at recurrence;
No contraindications for RFA and SBRT treatment;
Karnofsky performance score (KPS) ≥ 90;
Liver function Child-Pugh class A;
Normal liver volume greater than 800 cm3;
Expected survival time longer than 6 months;
The function of important organs meets the following requirements: a. white blood cell ≥ 3×109/L; b. hemoglobin ≥ 80 g/L; c. platelets ≥ 50×109/L; d. blood creatinine ≤ 1.5 times the upper limit; e. prothrombin time (PT) ≤ 3 seconds above control;
Subject has signed the informed consent form and agreed to the treatment and follow-up schedules according to this protocol;
Subject must have the ability to understand and voluntarily sign the written informed consent form prior to starting any specific procedure in the study.

Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Sun Yat-sen University Cancer Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát	Guangzhou	Kína	Ismeretlen állapot

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.