AK104 in Neoadjuvant Treatment of Cervical Cancer

Phase II Study on AK104 in Neoadjuvant Treatment of Cervical Cancer

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.

Inclusion Criteria:

1. Age≥18 & ≤75.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Histologically or cytologically confirmed diagnosis of primary cervical squamous cell carcinoma.
4. According to the 2018 International Federation of Cervical Cancer Obstetrics and Gynecology (FIGO) staging standard, the patient was diagnosed in stage IB2-IIA2.
5. Has not received any treatment before.
6. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
7. Has adequate organ function.

Exclusion Criteria:

1. 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.
2. Active Hepatitis B or Hepatitis C.
3. History of severe bleeding tendency or coagulation disorder.
4. Undergone major surgery within 30 days prior to the first dose of study treatment.
5. Pregnant or lactating female patients.
6. Drug or alcohol abuse.
7. 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.