NCT04625803已完成2 期
Camrelizumab and Apatinib Combined With Chemotherapy (mFOLFOX6) in Neoadjuvant Therapy for Locally Advanced Colon Cancer
Zhejiang University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年1月4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
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Tumor Regression Rate of MSS/pMMR Patients
研究概览
简要总结
To determine the Efficacy and Safety of camrelizumab and apatinib combined with chemotherapy (mFOLFOX6) for MSS/pMMR locally advanced colon cancer.
详细描述
To determine the rate of tumor regression grade 2-4 at time of radical resection of MSS/pMMR colon cancer following neoadjuvant treatment.To determine the pathologic downstage rates at time of radical resection of colon cancer following neoadjuvant treatment, pathologic complete response (pCR) rates, R0 resection rate, 2 year Disease free survival, OS(overall survival) and adverse events, including perioperative complication and mortality rate.
To determine the pathologic downstage rates and pCR rate of radical resection of MSI/dMMR colon 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, ≤75 years
- •Histologically confirmed colon cancer ( tumor penetrated of muscularis propria depth ≥5mm of T3 , T4, N0-2, M0) without distant metastasis (AJCC 8th).
- •Surgical treatment is planned after completion of neoadjuvant therapy
- •Patients can swallow pills normally
- •Expected overall survival ≥12 months
- •Blood routine: no blood transfusion or blood products usage within 14 days, G-CSF or other hematopoietic stimulator was not used. WBC counts > 3000/µl，Absolute neutrophil count (ANC) ≥ 1500 cells/µl，Platelet count ≥ 100,000/µl，Hemoglobin ≥ 9.0 g/dL.
- •AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN
- •Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
- •Patients who have not received systemic chemotherapy or immunotherapy
- •Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;
- •Informed consent has been signed.
排除标准
- •Patients have received any prior systemic antitumor therapy;
- •Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6 months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes are currently being used or have been used recently (10 days prior to the commencement of study treatment); Surgery (except for biopsy) was performed within 4 weeks prior to the study or the surgical incision was not fully healed; Aspirin (> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and silotazole are currently being used or have recently been used (10 days prior to the study).
- •Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2 weeks prior to treatment. Immunosuppressive drugs were started or expected to be used during the trial. Inhaled corticosteroids, physiologic replacement doses of glucocorticoids are allowed.
- •Certain or suspected distant metastases.
- •The patient has a history of autoimmune disease.
- •Serious uncontrolled systemic diseases, such as severe active infections;
- •A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive;
- •Patients have suffered from other malignancies in the past 5 years except cervical carcinoma in situ or basal cell carcinoma of the skin
- •Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA >500 IU/mL) or active HCV carriers with HCV RNA can be detected. Remarks: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) may be enrolled
- •Anti-infective therapy was not discontinued 14 days before the study;
- •A prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia, and symptomatic interstitial lung disease or the presence of active pneumonia on a chest CT scan within 4 weeks prior to the study.
- •Patients have a history of intestinal obstruction within six months. Patients with incomplete obstruction syndrome of ileus at the time of initial diagnosis may be enrolled in the study if they have received definitive (surgical) treatment to resolve the symptoms, as assessed by the investigator.
- •Patients have non-resectable factors, including surgical contraindications
- •Patients Have high blood pressure that cannot be well controlled by antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- •Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein >1.0g;
- •Known to be allergic to any study drug;
- •Patients have participated in other drug clinical studies within 4 weeks before enrollment;
- •Lactating women
- •According to the judgment of the researcher, the patient may have other factors that may affect the results of the study or cause the study to be terminated, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) requiring combined treatment. Patients have severe laboratory abnormalities, which will affect the safety of the patient.
研究组 & 干预措施
chemotherapy, PD-1 inhibitor and Apatinib
Experimental
Participants received 5 preoperative cycles of PD-1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery. Apatinib,PD-1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy.
干预措施: Camrelizumab , apatinib and chemotherapy (Drug)
结局指标
主要结局
Tumor Regression Rate of MSS/pMMR Patients
时间窗: 2 years
the percentage of tumor regression rate (2-4) in pMMR patients
次要结局
- Pathologic Complete Response (pCR) Rates(2 years)
- R0 Resection Rate(2 years)
- The Rate of 2 Year Disease Free Survival (DFS)(2 years)
- Overall Survival (OS)(2 years)
- Event Free Survival (EFS)(2 years)
- Perioperative Complication Rate(3 months)
- Mortality Rate(2 years)
研究者
Weijia Fang, MD
Director of Medical Oncology
Zhejiang University
研究点 (1)
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