Status:
COMPLETED
AK104 in Neoadjuvant Treatment of Cervical Cancer
Lead Sponsor:
Akeso
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Phase II open label study to evaluate the safety and efficacy of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) in neoadjuvant treatment of cervical cancer.
Eligibility Criteria
Inclusion
- Age≥18 \& ≤75.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma.
- According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA2.
- Has not received any treatment before.
- Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
- Has adequate organ function.
Exclusion
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Active Hepatitis B or Hepatitis C.
- History of severe bleeding tendency or coagulation disorder.
- Undergone major surgery within 30 days prior to the first dose of study treatment.
- Pregnant or lactating female patients.
- Drug or alcohol abuse.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator.
Key Trial Info
Start Date :
February 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05227651
Start Date
February 10 2023
End Date
September 27 2024
Last Update
November 1 2024
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hanzhong, Zhejiang, China, 310022