NCT06679673尚未招募2 期
An Explorative Study of SHR-1701 Combined with SHR2554 and BP102(bevacizumab) for Metastatic Colorectal Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Response to oncologic treatment in mCRC is currently limited.
详细描述
This is a single-center, open-labeled study exploring the efficacy and safety of SHR-1701 combined with SHR2554 and BP102 in the treatment of metastatic colorectal cancer (mCRC) .
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
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years;
- •Histological confirmed metastatic colorectal cancer;
- •ECOG PS 0-1;
- •At least one measurable lesion (according to RECIST1.1);
- •Adequate hepatic, renal, coagulation, and hematologic functions;
- •Agree to use contraception during the study and 3 months after the end of the study. Negative serum pregnancy test at screening for women of childbearing potential;
- •Patients voluntarily enroll in the study.
排除标准
- •The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- •Symptomatic brain or meningeal metastases (except for those whose BMS disease is stable for at least 4 weeks);
- •Allergy to the study drug or any of its excipients;
- •Prior treatment with immune checkpoint inhibitors;
- •Received the following treatments before the first study treatment;
- •Major surgery within 28 days before treatment (tissue biopsy for diagnostic purposes is permitted).
- •Prior use of immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/d prednisone or equivalent pharmacologic doses of other corticosteroids) within 7 days before treatment;
- •Received immunomodulatory drugs within 3 weeks before treatment;
- •Received live attenuated vaccine within 28 days before treatment;
- •Receipt of other antitumor systemic therapy within 28 days prior to treatment;
- •Presence of any active autoimmune disease or history of autoimmune disease with expected relapse;
- •A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- •Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA ≥ 2500 IU/ml and abnormal liver function; hepatitis C or co-infection with hepatitis B and hepatitis C;
- •A history of interstitial lung disease or non-infectious pneumonia, etc.;
- •Within 6 months before enrollment, the following conditions: myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; hypertension with poorly controlled by medications;
- •A history of severe bleeding within 3 months (>30 ml at a time) or hemoptysis within 1 month (>5 ml at a time) or a thromboembolic event (including pulmonary embolism, cerebral infarction, etc.) within 12 months;
- •Surgical treatment (except biopsy) within 6 weeks or unhealed surgical incision;
- •Long-standing unhealed wounds or fractures that have not healed properly
- •Imaging showing that the tumor has invaded a vital vascular perimeter or if, in the judgment of the investigator, the patient's tumor has a very high likelihood of invading a vital blood vessel and causing a fatal hemorrhage during therapy
- •A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, or active gastrointestinal bleeding within 6 months before the first study treatment
- •Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g;
- •Unable to take the drug orally, or has a condition judged by the investigator to affect the absorption of the drug;
- •Pregnancy, lactation, and unwillingness of reproductively active subjects to use effective contraception;
- •Other conditions deemed by the investigator to be ineligible for inclusion in the study.
研究组 & 干预措施
SHR-1701+BP102±SHR2554
Experimental
The first 6 subjects will be treated with SHR-1701+BP102, and the subsequent subjects will be treated with SHR-1701+BP102+SHR2554
干预措施: SHR-1701 (Drug)
SHR-1701+BP102±SHR2554
Experimental
The first 6 subjects will be treated with SHR-1701+BP102, and the subsequent subjects will be treated with SHR-1701+BP102+SHR2554
干预措施: BP102 (Drug)
SHR-1701+BP102±SHR2554
Experimental
The first 6 subjects will be treated with SHR-1701+BP102, and the subsequent subjects will be treated with SHR-1701+BP102+SHR2554
干预措施: SHR2554 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: assessed up to 1 year
the proportion of patients with complete response or partial response, using RECIST v 1.1.
次要结局
- Disease Control Rate (DCR)(assessed up to 1 year)
- Progression-Free Survival (PFS)(assessed up to 1 year)
- Overall survival (OS)(assessed up to 2 year)
研究者
研究点 (1)
Loading locations...
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