Efficacy and Safety of Total Neoadjuvant Chemoradiotherapy Combined With PD-1 Therapy for Locally Advanced Rectal Cancer With High Risk of Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- pathological complete response rate
研究概览
简要总结
Research Objective:To investigate the efficacy and safety of the "total neoadjuvant chemoradiotherapy combined with immunotherapy" regimen for the treatment of locally advanced rectal cancer with high-risk features for recurrence.
Study Design:A single-arm, multicenter clinical study.
Study Population: Patients with locally advanced rectal cancer presenting with high-risk features for local recurrence.
详细描述
Study Title:A Single-Arm, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Total Neoadjuvant Chemoradiotherapy Combined with PD-1 Inhibitor Immunotherapy in Locally Advanced Rectal Cancer with High-Risk Features for Recurrence
Background and Rationale:
Locally advanced rectal cancer (LARC) with high-risk features, such as involved mesorectal fascia, extramural vascular invasion, or low-lying tumors, is associated with a significant risk of local recurrence and distant metastasis following standard treatment. Total neoadjuvant therapy (TNT), which administers both chemotherapy and chemoradiotherapy prior to surgery, has emerged as a strategy to improve pathological outcomes and systemic control. The integration of immune checkpoint inhibitors, specifically PD-1 inhibitors, into TNT regimens is a promising approach. It is hypothesized that radiotherapy may potentiate the immune response by increasing tumor antigen exposure, thereby enhancing the efficacy of immunotherapy and potentially leading to higher rates of complete response and improved long-term survival.
Primary Objective:
The primary objective of this study is to evaluate the efficacy of the combined TNT and PD-1 inhibitor regimen, as measured by the pathological complete response (pCR) rate, defined as the absence of viable tumor cells in the primary tumor and lymph nodes upon pathological examination after surgical resection.
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
- •Pathologically confirmed rectal adenocarcinoma;
- •Mid-low rectal cancer, with the lower edge of the tumor located within 12 cm from the anal verge;
- •Magnetic resonance imaging (MRI) suggests locally advanced rectal cancer (T3 or T4 and M0), accompanied by at least one of the following risk factors: cT4, N2, lymphovascular invasion, involvement of the mesorectal fascia, or enlarged lateral lymph nodes (short-axis diameter > 8 mm); patients with potentially resectable disease;
- •Polymerase chain reaction (PCR) testing indicates microsatellite stability (MSS) type;
- •No prior antitumor therapy, such as chemotherapy, radiotherapy, immunotherapy, or targeted therapy;
- •Age between 18 and 75 years;
- •ECOG Performance Status (PS) score of 0-1;
- •Laboratory test results: WBC ≥ 3.5 × 10^9/L, Hb ≥ 100 g/L, PLT ≥ 100 × 10^9/L; normal liver and kidney function;
- •Absence of severe comorbidities, and ability to tolerate surgical treatment;
- •The patient or their immediate family member voluntarily agrees to participate in this study and provides written informed consent.
排除标准
- •Recurrent rectal cancer;
- •Synchronous colorectal cancer;
- •Pregnant or lactating patients;
- •History of other malignant tumors;
- •Previous antitumor therapy, including chemotherapy or radiotherapy;
- •Dysfunction of vital organs such as cardiac or pulmonary insufficiency;
- •History of autoimmune diseases or immunodeficiency disorders;
- •Use of immunosuppressive drugs within the past year;
- •Distant metastasis to organs such as the abdominal cavity, pelvis, liver, or lungs;
- •Active bleeding;
- •Tumor involvement of adjacent structures such as the prostate or sacral organs, making the tumor unresectable;
- •Allergy to chemotherapeutic agents, immune checkpoint inhibitors, or cetuximab;
- •Psychiatric disorders or lack of capacity for civil conduct, unable to provide informed consent.
研究组 & 干预措施
TNT-immunity
1
干预措施: PD-1 (Drug)
结局指标
主要结局
pathological complete response rate
时间窗: up to 2 months
the incidence of no tumor residual after the treatment
次要结局
未报告次要终点
研究者
Liu Liu
Principal Investigator
The First Affiliated Hospital of University of Science and Technology of China