Adjuvant immune checkpoint inhibitors after liver cancer surgery
Official title: Adjuvant Immune CheckPoint InhibitoRs Based ThErapy in PostoperatiVe HEpatocellular CarciNoma: a ProspecTive Real-world Study
Run by Guangxi Medical University · NCT05221398 · Data updated 2026-11-12
This study looks at whether giving immune checkpoint inhibitors after liver cancer surgery is safe and helpful for people at high risk of recurrence.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Guangxi Medical University Academic / other |
| Locations | 1 site (Nanning, Guangxi) |
| Status | Recruiting |
| Started | March 3, 2019 |
| Main results expected | December 18, 2030 |
| Study ends | December 30, 2030 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT05221398 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with hepatocellular carcinoma who had curative liver resection, Child-Pugh A or B liver function, good performance status, and high risk of recurrence.
✕Probably not a fit
Patients with low recurrence risk, poor liver function (beyond Child-Pugh B), or contraindications to immunotherapy may not benefit and could experience adverse effects.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective cohort study assessing adjuvant immune checkpoint inhibitor therapy versus active surveillance in patients who have undergone curative hepatectomy for hepatocellular carcinoma. It focuses on individuals with high risk of recurrence, including factors like large tumor size or vascular invasion, and uses real-world clinical data. The study aims to observe safety and efficacy in routine practice, complementing randomized trials. It is led by Guangxi Medical University and conducted at a single site in Nanning, China. No randomized design is specified, and results will inform future use in the postoperative setting.
Why it matters
Potential benefit: If successful, patients could experience lower recurrence rates and improved survival after surgery.
How similar studies have gone: Other trials are exploring adjuvant immunotherapy in postoperative HCC, but real-world post-surgery effectiveness remains to be demonstrated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Underwent curative hepatectomy; * Diagnosis of HCC was confirmed by postoperative histopathology; * Liver function Child-Pugh A or B; * Performance status score 0 or 1 * With high risk factor of HCC recurrence, such as tumor size ≥ 5 cm, multinodular, macrovascular invasion or microvascular invasion; Exclusion Criteria: * Receive neoadjuvant immune checkpoint inhibitors therapy.
Where it's running
-
Jian-Hong Zhong
Nanning, Guangxi, China Recruiting
Study contacts
- Study coordinator: Jian-Hong Zhong, PhD
- Email: zhongjianhong@gxmu.edu.cn
- Phone: +86 15296561499
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.