Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT07077369
Eligibility Criteria:
Inclusion Criteria:
* Patients with pathologically confirmed hepatocellular carcinoma (HCC);
* Patients who have undergone curative resection or ablation (limited to radiofrequency ablation \[RFA\] or microwave ablation \[MWA\]) within 4-12 weeks prior to enrollment: For those who have undergone curative surgical resection, postoperative pathological examination must confirm negative surgical margins (R0 resection); for those who have undergone ablation, complete radiological response must be demonstrated (complete disappearance of arterial enhancement in all ablated tumor lesions);
* Patients with high-risk factors for recurrence and metastasis following curative resection of HCC;
* Positive for hepatitis B surface antigen (HBsAg);
* No extrahepatic metastasis confirmed by contrast-enhanced CT or MRI either before curative resection or postoperatively.
(Additional inclusion criteria may be supplemented.)
Exclusion Criteria:
* Diagnosed with non-hepatocellular carcinoma such as fibrolamellar carcinoma, sarcomatoid carcinoma, or cholangiocarcinoma mixed with hepatocellular carcinoma;
* Evidence of residual tumor, recurrence, or metastasis;
* Clinically significant ascites;
* Received antitumor treatment after curative resection, excluding a single cycle of TACE (transarterial chemoembolization);
* History of hepatic encephalopathy. (Additional exclusion criteria may be supplemented.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07077369
Study Brief:
Protocol Section:
NCT07077369