Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecific Antibody) Combined With Chemotherapy as Neoadjuvant Treatment for Advanced Ovarian Cancer: a Single-arm, Open-label, Multicenter Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Complete(R0) resection rate
研究概览
简要总结
Previous studies have suggested that immunotherapy combined with chemotherapy as neoadjuvant treatment for ovarian cancer may have a synergistic effect and a manageable safety profile.
AK104 is a bispecific antibody targeting PD-1 and CTLA-4. Therefore, this study aimed to evaluate the efficacy and safety of AK104 combined with chemotherapy as the neoadjuvant treatment for advanced ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman ≥ 18 and ≤ 75 years old on day of signing informed consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
- •Advanced FIGO stage III to IV patient not able to receive primary debulking surgery for which neo adjuvant chemotherapy is recommended.
- •Have at least one measurable lesion per RECIST 1.1 assessed by investigator.
- •Have adequate organ function.
排除标准
- •Histological diagnosis of malignant tumor of non-epithelial origin of the ovary, the fallopian tube or peritoneum or borderline tumor of the ovary.
- •Patients with other active malignancies within 5 years prior to enrollment.
- •Known active autoimmune diseases.
- •Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
- •Presence of other uncontrolled serious medical conditions.
研究组 & 干预措施
AK104+chemotherapy
Participants received 3-4 neo-adjuvant cycles of AK104 10mg/kg Q3W then [paclitaxel (135-175 mg/m²) or docetaxel (75 mg/m²)] and [carboplatin (AUC5 or 6) or cisplatin (75mg/m²)] Q3W; followed by surgery
干预措施: AK104 - Chemotherapy (Drug)
结局指标
主要结局
Complete(R0) resection rate
时间窗: Average 4 months after the start of drugs
The margin of the resected specimen showed no tumour involvement
次要结局
- Objective Response Rate (ORR)(At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days))
- Disease control rate (DCR)(At the end of 3-4 cycles of neoadjuvant therapy (each cycle is 21 days))
- Progression-free survival (PFS)(From the date of the start of drugs to date event, assessed up to 1 years)
- Number of participants with adverse events (AEs)(From the first dose of neoadjuvant treatment until 90 days after the last dose of neoadjuvant treatment)
- Pathological Complete Response (pCR) Rate(One week after the surgery)
- Number of participants with surgical complications(Intraoperatively, within 30 days after surgery)