NCT06923176Toborzás még nem indult4. fázis
Effect of Biejia-Ruangan Compound on Survival Rate and Recurrence Rate of Hepatocellular Carcinoma After Radical Treatment
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 11. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
This study plans to enroll 704 patients with a history of chronic hepatitis B who have undergone radical treatment for hepatocellular carcinoma. The subjects were divided into a control group (conventional treatment group) and a combination therapy group (conventional treatment plus Biejia-Ruangan compound) according to the doctor's clinical diagnosis and treatment and the subjects' wishes in a ratio of 1:2. The subjects in the combination therapy group were treated with Biejia-Ruangan compound for 72 weeks, followed by 168 weeks of follow-up, for a total study period of 240 weeks. By analyzing the 1-, 2-, 3-, and 5-year recurrence-free, overall survival rate/survival time, adverse reactions, etc., the clinical effect of Biejia-Ruangan compound in reducing the risk of recurrence in patients with hepatocellular carcinoma after receiving radical treatment was comprehensively evaluated, and its scientific value and practical application prospects as a potential treatment method were explored.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 704 (tervezett)
- Első benyújtás
- 2025. ápr. 4.
- Kezdés
- 2025. ápr. 19.
- Elsődleges befejezés
- 2031. ápr. 30.
- Fő szponzor
- Zhiyun Yang
- Betegségek
- Máj- és epeúti rák
- NCT-szám
- NCT06923176
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Tervezett résztvevők: 704
- 2025. ápr. 19. és az elsődleges befejezés (2031. ápr. 30.) 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.
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Korábbi kezelés
- Prior to radical liver cancer surgery, the patient had received radiation, chemotherapy, molecular targeting, immunotherapy, and other anti-tumor treatments;
- Patients who experience upper gastrointestinal bleeding within the first 3 months (including the screening period) prior to screening;
- Individuals who plan to receive organ transplantation or have already undergone organ transplantation;
- Have used other anti fibrotic drugs within the first 6 months of enrollment, such as Fuzheng Huayu, Anluo Huaxian, and Ganshuang Granules.
- Other situations where the participant has participated in other intervention trials within the previous month or where the researcher deems it unsuitable for inclusion.
Más betegség
- Individuals with mental illnesses, especially those with a history of depression, anxiety, mania, schizophrenia, or a family history of mental illness (especially those with a history of depression or tendencies towards depression);
- Combination of hepatitis A, C, D, E, and/or current HIV infections;
- Autoimmune diseases, including psoriasis, systemic lupus erythematosus, autoimmune liver disease, etc;
- Individuals with a serious history of heart disease, especially those with unstable or poorly controlled heart disease within the past 6 months;
- Those who are allergic to Compound Biejia Ruangan Tablets, nucleoside (acid) analogues, or drug excipients, or who meet any contraindications in the experimental drug instructions;
Laborértékek
- Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, etc., or screening with blood creatinine>2.0 × ULN;
Egyéb
- Pregnant and lactating women;
- Receive other anti-tumor Chinese medicine (including traditional Chinese patent medicines and simple preparations or Chinese herbal medicine);
Kiket keres a vizsgálat
- Age range: 18-75 years old (including 18 and 75 years old), regardless of gender.
- Individuals with chronic hepatitis B liver fibrosis or cirrhosis.
- According to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer" (2024 edition) liver cancer diagnosis roadmap, the first clinical diagnosis is Hepatocellular carcinoma(HCC).
- The staging of liver cancer is CNLC stage Ia - IIa.
- Radical treatment has been completed, with surgical resection or local ablation.
- 8-12 weeks after radical surgery, imaging and serological evaluations showed no residual cancerous lesions and no new cancerous lesions were found.
- Child Pugh score A/B.
- Voluntarily joining the group, able to understand and sign an informed consent form.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.