Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05489289

A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

Led by Akeso · Updated on 2025-03-12

570

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.

CONDITIONS

Official Title

A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathological diagnosis of hepatocellular carcinoma without any metastasis
  • Underwent radical resection as the only anti-tumor treatment
  • No evidence of residual cancer during or after surgery
  • Presence of high risk factors for postoperative recurrence
  • Child-Pugh grade A liver function
  • ECOG performance status score of 0
  • Controlled underlying causes of hepatocellular carcinoma
Not Eligible

You will not qualify if you...

  • Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, or similar
  • Any anti-tumor treatment other than radical surgery before randomization
  • Severe liver function complications indicating precarious liver function
  • Recent procedures or medications causing high risk of bleeding
  • Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia, or similar
  • Inability to perform enhanced CT or MRI scans of the liver
  • Recent severe infections or recent use of systemic antibiotics
  • Active autoimmune diseases
  • History of other incurable malignant tumors
  • History of transplantation
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

T

Ting Liu, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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