NCT04815408招募中2 期
A Phase II Study of PD-1 Antibody Plus Neoadjuvant Chemotherapy for Advanced-stage Ovarian Cancer (Z2HOC-01)
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed adenocarcinoma of ovary, fallopian tube, primary peritoneum (Non-mucinous adenocarcinoma)
- •Clinical stage IIIC/IV, and IIIC with Suidan CT ≥3 or Fagotti ≥8
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 2
- •Not received any immunotherapy before
- •Willing to participate in this study, and sign the informed consent.
排除标准
- •With other uncontrolled malignant tumors.
- •Any disease requiring systemic treatment with a corticosteroid (prednisone or equivalent daily dose of > 10mg) or other immunosuppressive agents during the 14 days prior to randomization.The use of topical substitute steroids (daily dose ≤10mg of prednisone or its equivalent) and prescription corticosteroids for short-term (≤7 days) prophylactic use or for the treatment of non-autoimmune conditions is permitted.Has any active autoimmune disease or a history of autoimmunity.
- •A history of active autoimmune disease or autoimmune disease that may recur.Enrolment was allowed for well-controlled type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, well-controlled celiac disease, skin conditions (such as vitiligo, psoriasis, or alopecia) that did not require systemic treatment, or conditions that were not expected to recede without an external cause.
- •A history of interstitial lung disease, non-infectious pneumonia, or poorly controlled diseases (including pulmonary fibrosis, acute lung disease, etc.).
- •Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen [HBsAg] test result and HBV-DNA test value higher than the upper limit of normal value in the laboratory of the research center) or hepatitis C (defined as positive hepatitis C virus surface antibody [HCSAB] test result and positive HCV-RNA test result).
- •Known human immunodeficiency virus (HIV) infection (known to be HIV positive).
- •Have received live vaccine within 30 days before the first administration.This includes but is not limited to the following: mumps, rubella, measles, varicella/herpes zoster (varicella), yellow fever, rabies, BCG and typhoid vaccines (inactivated virus vaccines are allowed).
- •With uncontrolled cardiac clinical symptoms or diseases.
- •Allergic to any drug in this program.
- •At the discretion of the Investigator, the subject has a history or current evidence of any disease, treatment or laboratory anomaly that may confuse the results, interfere with the participants' participation throughout the study, or is not in the best interest of the participants to participate in the study.
研究组 & 干预措施
NIC
Experimental
- Neoadjuvant treatment BGB-A317 200mg q3 weeks (total 3 dosing) Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing)
- Interval debulking surgery and HIPEC
- Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)
干预措施: BGB-A317 (Drug)
NIC
Experimental
- Neoadjuvant treatment BGB-A317 200mg q3 weeks (total 3 dosing) Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing)
- Interval debulking surgery and HIPEC
- Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)
干预措施: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 (Drug)
NC
Active Comparator
- Neoadjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 q3 weeks (total 3 dosing)
- Interval debulking surgery and HIPEC
- Adjuvant treatment Chemotherapy regimen: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5, Bevacizumab 7.5mg/kg q3 weeks (total 3 dosing)
干预措施: albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5 (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 12 months
12 months progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
次要结局
- CRR(3 months)
- R0 rate(after interval debulking surgery for one week)
- PRR(3 months)
- OS(5 years)
- AEs(3 months)
研究者
研究点 (1)
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