Camrelizumab Combined With Trastuzumab and Chemotherapy in Patients With HER2-positive Advanced Colorectal Cancer: A Prospective, Single-arm, Open-label Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of camrelizumab combined with trastuzumab and chemotherapy in Patients with HER2-positive advanced colorectal 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects has voluntarily agreed to sign the informed consent and have good compliance and are willing to cooperate with follow-up.
- •Age 18 years or older, male or female.
- •Have a life expectancy of at least 3 months.
- •Histologically confirmed diagnosis of unresectable recurrent or metastatic HER2 positive colorectal cancer.
- •HER2 positivity defined as the colorectal cancer-specific HERACLES diagnostic criteria or NGS sequencing of tumor tissue/blood samples showed HER2 amplification.
- •Patients have not received systemic anti-cancer treatment in the past or had disease progression more than 6 months after receiving after (neo)adjuvant treatment could be enrolled or failure of first-line therapy or completion of (new) adjuvant therapy to disease recurrence less than 6 months.
- •At least one measurable or evaluable lesion, as defined by RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •The functional level of the major organs must meet the following requirements:(1)Blood routine: neutrophils (ANC) ≥1.5×10^9/L; platelet count (PLT)≥90×10^9/L; hemoglobin (Hb) ≥90 g/L; (2)Blood biochemistry: TBIL≤1.5×ULN; ALT and AST≤2.5×ULN; Cr≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); for subjects with liver metastasis: TBIL≤3×ULN; ALT and AST≤5×ULN; (3)Patients was not receiving anticoagulation therapy (INR ≤ 1.5 or aPTT ≤ 1.5 × ULN). If the patient received prophylactic anticoagulation therapy and the INR ≤ 2 × ULN within 14 days before the start of the study and the aPTT/PPT is within the normal range could be enrolled; (4)Left ventricular ejection fraction (LVEF) ≥55% (within 28 days).
- •Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.
排除标准
- •Have previously received any co-stimulatory or co-inhibitory T cell receptor antibody or drug therapy, including PD-1, PD-L1, PD-L2, CD137, CTLA-4, etc.
- •Have previously received anti-HER2 targeted therapy (monoclonal antibody or small molecule TKI).
- •Have any active autoimmune diseases or autoimmune diseases in the past 2 years.
- •Have used immunosuppressive drugs within 4 weeks before the first dose of study drug treatment.
- •Allergic to any monoclonal antibody or chemotherapeutic drug preparation component.
- •Receive a live attenuated vaccine within 4 weeks before the first dose of study drug treatment.
- •Known symptomatic central nervous system metastases and/or cancerous meningitis. If subjects with brain metastases who have been treated in the past are in stable condition, they could be enrolled.
- •Pleural and abdominal effusion requiring clinical treatment, or third interspace effusion.
- •Suffering from congenital or acquired immune deficiency.
- •Known history of human immunodeficiency virus (HIV) infection.
- •Subjects who have received allogeneic tissue/solid organ transplantation.
- •Known to have active tuberculosis.
- •Known to have acute or chronic active hepatitis B or acute or chronic active hepatitis C.
- •Severe infections that are active or poorly clinical controlled.
- •Known history of (non-infectious) pneumonia requiring steroid treatment or currently suffering from pneumonia.
- •Other poorly controlled comorbidities.
- •Pregnancy or breastfeeding or planning to pregnancy or childbirth during the study period.
- •Have uncontrolled cardiac clinical symptoms or diseases.
- •Malignant tumors that are progressing or require active treatment in the past 5 years, except for the following: (1) Malignant tumors that have been completely relieved for at least 2 years before enrollment and no other treatment is required during the study period; (2) Non-melanoma skin cancer or malignant freckle-like nevus that has been adequately treated and has no evidence of disease recurrence; (3) Carcinoma in situ with adequate treatment and no evidence of disease recurrence.
- •According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway.
研究组 & 干预措施
Camrelizumab combined with trastuzumab and chemotherapy
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
干预措施: Camrelizumab (Drug)
Camrelizumab combined with trastuzumab and chemotherapy
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
干预措施: Trastuzumab (Drug)
Camrelizumab combined with trastuzumab and chemotherapy
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
干预措施: XELOX regimen (Drug)
Camrelizumab combined with trastuzumab and chemotherapy
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
干预措施: mFOLFOX6 regimen (Drug)
Camrelizumab combined with trastuzumab and chemotherapy
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
干预措施: FOLFIRI regimen (Drug)
Camrelizumab combined with trastuzumab and chemotherapy
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
干预措施: mXELIRI regimen (Drug)
Camrelizumab combined with trastuzumab and chemotherapy
Camrelizumab: 200mg, iv, 21d for a treatment cycle Trastuzumab: 8 mg/kg loading dose, followed by 6 mg/kg maintenance, iv, 21d for a treatment cycle Chemotherapy will either be XELOX, mFOLFOX6, FOLFIRI, mXELIRI or mIRIS
干预措施: mIRIS regimen (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: [ Time Frame: Approximately 24 months ]
The proportion of patients with complete response or partial response according to RECIST v1.1
次要结局
- Duration of Response([ Time Frame: Approximately 24 months ])
- Disease Control Rate([ Time Frame: Approximately 24 months ])
- Progression-Free Survival([ Time Frame: Approximately 24 months ])
- Overall Survival([ Time Frame: Approximately 24 months ])