Efficacy and Safety of Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer: a Single-center, Retrospective, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- pathologic complete response
研究概览
简要总结
It is a single-center, retrospective, controlled study to investigate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.
详细描述
Study Purpose
- To evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin for locally advanced mid-low rectal cancer.
- To explore the effects of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin on the immune microenvironment of locally advanced mid-low rectal cancer.
Study Design: A single-center, retrospective, controlled study Subjects were divided into two groups according to whether or not they received thymalfasin: group 1 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor, and group 2 was treated with neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin.
Subjects received long course radiotherapy (50 Gy/25f, 2 Gy/f, 5 days/week) for the first 5 weeks and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day 8) for the first 9 weeks. After that, patients rested for two weeks (week 10-11)。6-8 weeks after the end of radiotherapy, patients underwent TME surgery (12-14 weeks). Thymalfasin was started on the first day of neoadjuvant chemoradiotherapy, 1.6 mg subcutaneously twice a week until the end of the last neoadjuvant treatment.
Enrollment: preoperative Tα1 (n=14), postoperative Tα1 (n=7), or no Tα1 (n=26) Study Population: locally advanced mid-low rectal cancer Primary Endpoint: 3-y DFS, pCR rate Exploratory endpoint: Paraffin specimens were collected from biopsies before neoadjuvant therapy and after surgery in patients meeting the inclusion criteria. The expression of CD86, CD163, CD4+T，CD8+T，PD-1 were detected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patients with rectal adenocarcinoma must satisfied all the following conditions:
- •Stage II/III LARC (cT1-4aN0-2M0);
- •Tumor distal location≤10 cm from anal verge (MRI diagnosed);
- •Patients regardless of gender with aged≥18 years
- •ECOG score of 0 or 1
- •Physical and viscera function of patients can withstand major abdominal surgery
排除标准
- •Current or previous active malignancy other than rectal cancer；
- •Patients underwent major surgery within 4 weeks prior to neoadjuvant therapy；
- •Patients have any condition affects the absorption of capecitabine through gastrointestinal tract；
- •Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- •Patients with severe concomitant diseases with estimated survival≤5 years；
- •Patients with present or previous moderate or severe liver and kidney damage；
- •Patients preparing for or previously received organ or bone marrow transplant；
- •Patients who have received immunosuppressive or systemic hormone therapy within 1 month prior to the start of neoadjuvant therapy；
- •Patients with congenital or acquired immune deficiency (such as HIV infection)；
- •Pregnant or lactating women.
结局指标
主要结局
pathologic complete response
时间窗: 1 year
All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.
次要结局
- neoadjuvant rectal (NAR) score(1 year)
- R0 resection rate(1 year)
- tumor regression grade（TRG）(1 year)
- anal preservation rate(1 year)
- overall survival (OS)(3 year)
- objective response rate (ORR)(1 year)
- local recurrence free survival(3 year)
- disease free survival (DFS)(3 year)
研究者
Zhongtao Zhang
professor
Beijing Friendship Hospital