RecruitingPhase 2NCT06498622

Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab

Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma After Radical Surgery With Donafenib in Combination With Envafolimab: a Prospective, Multicentre, Single-arm Phase II Clinical Study


Sponsor

Anhui Provincial Hospital

Enrollment

45 participants

Start Date

Jul 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, single arm study to evaluate the efficacy and safety of donafenib in combination with envafolimab treatment in patients with high risk of recurrent hepatocellular carcinoma after radical surgery.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two drugs — donafenib (a targeted therapy) and envafolimab (an immunotherapy) — after surgery can reduce the chance of liver cancer (hepatocellular carcinoma) coming back in patients who are at high risk for recurrence. **You may be eligible if...** - You are between 18 and 80 years old and had surgery to remove liver cancer, confirmed by pathology, with clear margins - Your tumor has at least one high-risk feature: tumor ≥ 5 cm plus blood vessel invasion, 3 or more tumors, or portal vein involvement (vp1 or vp2) - No signs of cancer recurrence on imaging 3–7 weeks after surgery - Your liver and organ function are adequate **You may NOT be eligible if...** - You already show signs of cancer recurrence after surgery - You have other active cancers - Your liver function or blood counts are significantly impaired - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDonafenib + Envafolimab

Drug: Envafolimab Envafolimab 300mg IH D1 q3w Other Name: Immunotherapy, Anti-PD-L1 antibody Drug: Donafenib Donafenib 100mg PO bid Other Name: tyrosine kinase inhibitor, TKI


Locations(2)

No.2 People's Hospital of Fuyang city

Fuyang, Anhui, China

Anhui province hospital

Hefei, Anhui, China

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NCT06498622


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