NCT05660213Toborzás még nem indult
A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer
A Multicenter Registry Study on the Efficacy and Safety of Different Treatment Regimens for Unresectable CNLC Liver Cancer Stage III Hepatocellular Carcinoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. máj. 20. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
This study is a multicenter, registered research aimed at evaluating the efficacy of different treatment regimens in the treatment of unresectable CNLC liver cancer stage III hepatocellular carcinoma
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 750 (tervezett)
- Első benyújtás
- 2022. dec. 13.
- Kezdés
- 2025. aug.
- Elsődleges befejezés
- 2027. aug.
- Fő szponzor
- Fudan University
- Betegségek
- Máj- és epeúti rák
- NCT-szám
- NCT05660213
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 750
- 2025. aug. és az elsődleges befejezés (2027. aug.) között
- Nincs megadott helyszín, ország nélkül
- 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
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Korábbi kezelés
- Received radiation therapy within the past 4 weeks;
Más betegség
- Simultaneously having two or more active primary malignant tumors;
- Portal vein cancer thrombus invades the superior mesenteric vein;
Laborértékek
- Coagulation dysfunction (INR>2.0, PT>16 s) or diseases with a strong likelihood of bleeding (including but not limited to esophageal and/or gastric variceal bleeding, active ulcers, uncontrolled hypertension);
Egyéb
- Expected survival time is less than 3 months;
- Pregnant or lactating women or those planning to conceive;
- Refusing to cooperate with follow-up visits;
- Other reasons led the researchers to believe that it was not suitable to participate in this study.
Kiket keres a vizsgálat
- ·≥ 18 years old;
- Diagnosed as unresectable hepatocellular carcinoma through histopathological and/or cytological examination, or meeting the clinical diagnostic criteria for hepatocellular carcinoma in the 2022 edition of the guidelines for the diagnosis and treatment of primary liver cancer;
- CNLC liver cancer stage III;
- Liver function Child Pugh A or B grade 7 points;
- Has not received systematic treatment in the past;
- Patients with active HBV infection who meet one of the following conditions can be enrolled: ① Within 28 days before enrollment, the patient's HBV DNA is less than 500 IU/mL. If they have received anti HBV treatment, they need to continue their original antiviral treatment; If anti HBV treatment has not been received, it is necessary to receive anti HBV treatment throughout the entire course of medication (according to local treatment standards; for example, entecavir); ② For patients with HBV DNA>500 IU/mL and who have not received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Before enrollment, the serum HBV-DNA virus should be retested to decrease by more than 1 log value For patients with HBV DNA>500 IU/mL and who have received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Serum HBV-DNA virus levels should be retested before enrollment;
- Active HCV infected individuals with stable disease status after treatment;
- At least one tumor lesion available for evaluation;
- Clear consciousness, language expression ability or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation;
- Voluntarily join this study and sign an informed consent form.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.