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Trial Title:
A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection
NCT ID:
NCT05489289
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Recurrence
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
AK104
Description:
Subjects will receive AK104 until disease progression or for a maximum of 16 cycles
Arm group label:
AK104
Intervention type:
Biological
Intervention name:
placebo
Description:
Subjects will receive placebo until disease progression or for a maximum of 16 cycles
Arm group label:
placebo
Summary:
The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high
recurrence risk after curative resection.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathological diagnosis of HCC without any metastasis;
2. Receiving radical resection as the only anti-tumor treatment;
3. No evidence of residual cancer found during or after the operation;
4. Presence of any high risk factor of postoperative recurrence;
5. Child-Pugh grade: A;
6. ECOG score: 0;
7. Controlled underlying causes of HCC.
Exclusion Criteria:
1. Fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma,
cholangiocarcinoma, etc;
2. Any anti-tumor treatment other than radical surgery before randomization;
3. Precarious liver function indicated by severe complications;
4. Recent procedures or medications leading to high risk of bleeding;
5. Poorly controlled or symptomatic hypertension, congestive heart failure, arrhythmia,
etc;
6. Failure of performing enhanced CT or MRI scans of the liver;
7. Recent severe infections or systemic antibiotics use;
8. Active autoimmune diseases;
9. History of other incurable malignant tumors;
10. History of transplantation;
11. Pregnancy.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Jia Fan, Ph.D.
Phone:
021-31587871
Email:
fan.jia@zs-hospital.sh.cn
Start date:
September 24, 2022
Completion date:
November 1, 2026
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05489289
