An Open-label, Randomized, Controlled, Multicenter, Phase III Study of SHR-A2102 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-based Chemotherapy and PD-(L)1 Inhibitor Treatment Failed Recurrent or Metastatic Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of SHR-A2102 versus investigator's choice of chemotherapy in patients with platinum-based chemotherapy and PD-(L)1 inhibitor treatment failed recurrent or metastatic cervical 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participate in the study voluntarily, sign the informed consent form.
- •Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma that is deemed unsuitable for radical surgery and/or radical radiotherapy or chemoradiotherapy.
- •Provide primary or metastatic tumor samples.
- •At least one measurable lesion (RECIST version 1.1).
- •With adequate organ functions.
- •Expected overall survival is ≥12 weeks.
排除标准
- •With known untreated or active central nervous system (CNS) tumor metastasis, or a history of or current leptomeningeal metastasis.
- •With symptomatic, poorly controlled, or moderate-to-severe pleural effusion, pericardial effusion, or ascites.
- •With a history of or concurrent other malignant tumor(s).
- •Participants with gastrointestinal perforation or fistula, urogenital fistula, or those at risk of fistula within 3 months prior to randomization.
- •With known or suspected interstitial lung disease.
- •With intestinal obstruction or signs/symptoms suggestive of intestinal obstruction within 3 months prior to randomization.
- •With poorly controlled cardiac clinical symptoms or diseases.
- •Experienced arterial/venous thromboembolic events within 3 months prior to randomization.
- •With severe infections occurring within 1 month prior to randomization.
- •With active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] test and hepatitis B virus [HBV] DNA ≥500 IU/mL at screening) or active hepatitis C (defined as positive hepatitis C virus antibody [HCV-Ab] test and detectable hepatitis C virus [HCV] RNA at screening).
- •With active tuberculosis infection within 1 year prior to randomization, or a history of active tuberculosis infection more than 1 year ago without proper treatment.
- •With a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- •Have received systemic anti-tumor therapy within 28 days prior to randomization.
- •With uncontrolled psychiatric disorders, or known history of alcoholism, drug abuse, or substance dependence, incarceration, or other conditions that may affect the completion of study procedures.
- •Any other condition that, in the judgment of the investigator, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the participant unsuitable for the study.
研究组 & 干预措施
SHR-A2102 Group
Participants receive SHR-A2102 for injection.
干预措施: SHR-A2102 for Injection (Drug)
The investigator's choice of chemotherapy Group
Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound).
干预措施: Gemcitabine Hydrochloride for Injection (Drug)
The investigator's choice of chemotherapy Group
Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound).
干预措施: Pemetrexed Disodium for Injection (Drug)
The investigator's choice of chemotherapy Group
Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound).
干预措施: Paclitaxel for Injection (Albumin bound) (Drug)
The investigator's choice of chemotherapy Group
Participants receive the investigator's choice of chemotherapy, with optional chemotherapeutic agents including: Pemetrexed Disodium for Injection, Gemcitabine Hydrochloride for Injection, Topotecan Hydrochloride for Injection, Paclitaxel for Injection (Albumin bound).
干预措施: Topotecan Hydrochloride for Injection (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 3 years.
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.
次要结局
- Serious Adverse Events (AEs)(Up to 3 years.)
- Plasma concentrations of SHR-A2102(Up to 3 years.)
- Plasma concentrations of SHR-A2102 metabolites(Up to 3 years.)
- Incidence of Anti-Drug Antibody (ADA) of SHR-A2102(Up to 3 years.)
- Incidence of Neutralizing Antibodies (Nab) of SHR-A2102(Up to 3 years.)
- Adverse Events (AEs)(Up to 3 years.)
- Progression free survival (PFS)(Up to 3 years.)
- Objective Response Rate (ORR)(Up to 3 years.)
- Duration of response (DoR)(Up to 3 years.)
- Disease control rate (DCR)(Up to 3 years.)