Study on Adjuvant Treatment of MRD-positive Colorectal Cancer Patients With Routine Chemotherapy Combined With Personalized Immune Regulation Diagnosis and Treatment Technology
试验速览
- 阶段
- 早期 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy: Patients with MRD positive and high risk of recurrence after colorectal cancer surgery were enrolled. Surgical tumor tissue and blood samples were collected, tumor tissue samples were sequenced, neoantigens were analyzed, personalized immunomodulators were prepared, and routine adjuvant therapy combined with personalized immunomodulatory diagnosis and treatment technology were performed to prevent postoperative recurrence. To establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They must give informed consent, indicating that they understand the purpose of the study and the procedures required, and are willing to participate in the study.
- •Pathological examination confirmed colorectal adenocarcinoma.
- •For patients with stage II with high risk factors or stage III with radical surgery, stage II (high risk) colon cancer is defined as (any of):
- •a )T4 b)≥ Level 3 c) The clinical manifestations are intestinal obstruction or intestinal perforation d) Histological signs of vascular, lymphatic, or perineural invasion e) Check < 12 nodes
- •Patients with liver or lung metastases that can be resected in one stage with the primary lesion.
- •There must be sufficient formalin to fix the tumor material in the paraffin embedded (FFPE) block or section tissue (only after sponsor approval), preferably obtained from excision.
- •Patients should meet the following biochemical indicators: total bilirubin ≤2× upper limit of normal (ULN); AST and ALT≤2× upper limit of normal (ULN); Creatinine clearance ≥60 ml/min.
- •Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L.
- •Expected survival ≥ 3 months.
- •Postoperative ctDNA MRD test was positive, routine blood indexes were negative, and imaging was negative.
排除标准
- •Stage I patients and stage II patients without risk factors or MSI-H.
- •Stage IV patients who cannot be surgically resected.
- •Patients with liver, kidney, heart, lung and other dysfunction, unable to tolerate surgery or unable to complete follow-up chemotherapy.
- •Patients who refuse adjuvant therapy such as chemotherapy, are allergic to chemotherapy drugs and have poor compliance.
- •Patients who have received other immunotherapy within 1 month (such as immune checkpoint inhibitor therapy, therapeutic antibody therapy, immune cell therapy, and immune system modulator therapy)
- •Patients with a known past or current malignancy, except where a diagnosis is included, except in the following cases:
- •Stage 1B or below cervical cancer.
- •Non-invasive basal cell or squamous cell skin cancer.
- •Non-invasive superficial bladder cancer.
- •Prostate cancer with a current PSA level < 0.1 ng/mL.
- •Any curable cancer with a complete response (CR) duration of > 2 years.
- •Patients with hematological and autoimmune diseases.
- •Patients with active hepatitis B or C.
- •Patients affected by drug abuse, clinical or psychological or social factors that make informed consent or the implementation of research.
- •Pregnant and lactating women.
- •Patients with mental illness, senile dementia, etc.
研究组 & 干预措施
Experimental group
Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology
干预措施: Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology (Biological)
结局指标
主要结局
ORR
时间窗: Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
Exploration of the efficacy of Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology
次要结局
- OS(Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months)
- PFS(Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months)