Clinical trial · Observational
Postoperative Adjuvant Therapy of HCC Based on PD-1
PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| RFS | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitors | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PD-1 based therapy cohort
- description
- Patients who received PD-1 inhibitors or PD-1 inhibitors plus Lenvatinib therapy 2-4 weeks after the operation were included in the PD-1-based therapy cohort.
- interventionNames
- Drug: PD-1 inhibitors
- label
- TACE cohort
- description
- Patients who received 1 TACE about a month after the operation were included in the control cohort.
- interventionNames
- Procedure: TACE
Primary outcomes (1)
- measure
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available