A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery with High Risk of Recurrence
Interventionsstudie
Phase 2
Guangxi Medical University Cancer Hospital
Sponsor: Guangxi Medical University
Zuletzt aktualisiert: 28. März 2025 Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.
This study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.
* Sign a written informed consent before the implementation of any trial-related procedures.
* Male or female, aged ≥18 years and ≤70 years.
* ECOG PS score is 0 - 1 point.
* Subjects diagnosed with hepatocellular carcinoma by imaging criteria and/or pathology and who have received curative resection.
* The definition of curative resection complies with the definition of curativeness in the 2024 edition of the Chinese Guidelines for Primary Liver Cancer (CNLC).
* The postoperative recurrence risk stratification conforms to the high - risk group in the ERASL - pre or ERASL - post formula.
* No prior systemic antitumor treatment for hepatocellular carcinoma has been received.
* Child - Pugh liver function score of grade A or B7.
* Expected survival time > 6 months.
Ausschlusskriterien
* Previously diagnosed by histology/cytology, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
* Subjects with other malignant tumors within 5 years before enrollment, except for HCC. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
* History of hepatic encephalopathy or liver transplantation.
* Portal vein trunk or mesenteric superior vein, inferior vena cava tumor thrombus.
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Design-Details
ZuteilungN/A
InterventionsmodellSingle Group Assignment
MaskierungNone (Open Label)
Anzahl der Teilnehmer45
Arme & Interventionen
Arme
Interventionen
Typ: Experimental
Beschreibung: Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months.
Interventionen:
Cadonilimab (AK104)
Ergebnismessungen
Primäre Ergebnismessungen
Recurrence-free survival2 years
the recurrence-free survival would be calculated and compared among different groups.
Sekundäre Ergebnismessungen
Keine
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