A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II/III Study of SHR-1701 or Placebo in Combination With BP102 (Biosimilar to Bevacizumab) and XELOX in First-line Treatment of mCRC
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Phase 2:ORR
研究概览
简要总结
This is a two-arm, randomized, double-blinded, multicenter phase II/III clinical study to evaluate the safety and clinical efficacy of SHR-1701 or placebo in combination with BP102 (biosimilar to bevacizumab) and XELOX in first-line treatment of patients with mCRC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable recurrent or metastatic adenocarcinoma of the colon or rectum confirmed histologically
- •For subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
- •At least 1 measurable lesion according to RECIST V1.1
- •The vital organs are functioning well
- •ECOG score is 0 ~ 1
- •Contraception was initiated from the signing of the informed consent until at least 6 months after the last dosing of the study drug
排除标准
- •Recurrent or metastatic lesions can be treated with radical surgery
- •Presence of central nervous system or meningeal metastases;
- •Moderate and severe ascites of clinical symptoms;Uncontrolled or moderate or greater pleural effusion or pericardial effusion
- •Poorly controlled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in the case of regular antihypertensive therapy) and prior hypertensive crisis or hypertensive encephalopathy
- •Severe cardiovascular and cerebrovascular diseases;Have clinical heart symptoms or diseases that are not well controlledSubjects with a history of myocardial infarction or unstable angina pectoris
- •Subject with current interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy
- •Previous treatment with targeted T cell costimulatory molecules and immune checkpoint inhibitors;Previous treatment with antiepidermal growth factor receptor or any antiangiogenic drug
研究组 & 干预措施
SHR-1701 in combination with BP102 and XELOX（Phase 2）
干预措施: SHR-1701、 BP102 、XELOX (Drug)
SHR-1701 in combination with BP102 and XELOX （Phase 3）
干预措施: SHR-1701、 BP102 、XELOX (Drug)
placebo in combination with BP102 and XELOX
干预措施: placebo、 BP102、 XELOX (Drug)
结局指标
主要结局
Phase 2:ORR
时间窗: up to 2 years
Objective response rate (assessed by the investigators based on RECIST v1.1)
Phase 2:Incidence of Adverse Events (AEs) by CTCAE v5.0
时间窗: up to 2 years
Assess safety and tolerability of SHR-1701 in combination with BP102 and XELOX
Phase 3:PFS
时间窗: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)
次要结局
- Duration of response(up to 2 years)
- DCR(up to 2 years)
- PFS(up to 2 years)
- OS(up to 2 years)