CompletedNot Applicable

Postoperative Adjuvant Therapy of HCC Based on PD-1

China573 participantsStarted 2019-02-01

Plain-language summary

For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain * 2\. Patients with high-risk factors for tumor recurrence (tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion, portal vein thrombosis, and poorly differentiated) and received PD-1-based adjuvant therapy or TACE adjuvant therapy after the surgery * 3\. Aged18-75 * 4\. Eastern Cooperative Oncology Group (ECOG) performing status of 0-1 * 5\. Child-Pugh grade A or B * 6\. The patient knows, and informed consent was obtained Exclusion Criteria: * 1\. Any history of other malignant tumors or recurrent HCC * 2\. Any preoperative treatment for HCC including local and systemic therapy * 3\. Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency * 4\. Any persistent serious surgery-related complications * 5\. Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months * 6\. Inability or refusal to comply with the treatment and monitoring

What they're measuring

Disease-free survival

Timeframe: From date of inclued in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months

Trial details

NCT IDNCT05307926

SponsorChen Xiaoping

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-07-30