NCT06542549

Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer

Efficacy and Safety of AK104 (PD-1/CTLA-4 Bi-specific Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer: a Randomized Controlled, Single-center Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, single-center clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.

Detailed description

Subjects in the experimental group received AK104 combined chemotherapy for 3-4 cycles (determined by the investigator) before surgery, and subjects in the control group received chemotherapy for 3-4 cycles (determined by the investigator) before surgery. Treatment until unless intolerable toxicity occurs, informed consent is withdrawn, or other criteria for discontinuation are met. The study treatment was followed by a 3-week treatment cycle. The dosing time window is ±3 days. Within 72 hours before each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, and physical status score, to evaluate the safety and tolerability of continued treatment.

Conditions

• Advanced Ovarian Cancer
• AK104(PD-1/CTLA-4 Bispecial Antibody)
• Chemotherapy
• Efficacy
• Safety

Interventions

Type	Name	Description
DRUG	AK104	The study treatment was followed by a 3-week treatment cycle. The dosing time window is ±3 days. Within 72 hours before each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, and physical status score, to evaluate the safety and tolerability of continued treatment.

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-10-31
• Completion: 2030-10-31
• First posted: 2024-08-07
• Last updated: 2024-08-07