Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Complete Response (CR) Rate
研究概览
简要总结
To explore the complete response (CR) rate of modified short-course radiotherapy plus CAPOX and Tislelizumab versus Long-course Chemoradiotherapy plus Tislelizumab for locally advanced rectal cancer.
详细描述
In the exploration of treatments for locally advanced rectal cancer (LARC), the novel model combining short-course radiotherapy with CAPOX chemotherapy and PD-1 inhibitor (tislelizumab) is demonstrating promising potential. By comparing the efficacy and safety of modified short-course radiotherapy versus traditional long-course radiotherapy within this combination regimen, this study aims to identify the optimal radiotherapy strategy to maximize tumor regression and improve the complete response rate, thereby offering a more promising treatment option for rectal cancer patients seeking organ preservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 18-75 years, any gender.
- •Pathologically confirmed rectal adenocarcinoma.
- •Baseline MR stage T3-4/N+.
- •Distance from anal verge ≤12cm.
- •No distant metastasis.
- •Karnofsky Performance Status ≥
- •Adequate organ function, no contraindications to surgery, radiotherapy, or immunotherapy.
- •Microsatellite/mismatch repair status MSS/pMMR.
- •No prior chemotherapy or any other anti-tumor treatment before inclusion.
- •No prior immunotherapy.
- •Ability to comply with the study protocol during the study period.
- •Signed written informed consent.
排除标准
- •Pregnant or lactating women.
- •Pathological diagnosis of signet ring cell carcinoma.
- •History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
- •Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
- •Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
- •Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
- •Patients with autoimmune diseases.
- •Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
- •Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10^9/L; platelets ≥100×10^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP
- •≤2.5 times the upper limit of normal; serum total bilirubin <1.5 times the upper limit of normal; serum creatinine <1 times the upper limit of normal; serum albumin ≥30g/L.
- •Known deficiency of dihydropyrimidine dehydrogenase (DPD).
- •Allergy to any investigational drug components.
研究组 & 干预措施
Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab
Modified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w *4 cycles.Efficacy and surgery were assessed after the end of treatment.
干预措施: Modified Short-course radiotherapy (Radiation)
Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab
Modified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w *4 cycles.Efficacy and surgery were assessed after the end of treatment.
干预措施: Oxaliplatin (Drug)
Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab
Modified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w *4 cycles.Efficacy and surgery were assessed after the end of treatment.
干预措施: Capecitabine (Drug)
Modified Short-course radiotherapy Combined with CAPOX plus Tislelizumab
Modified Short-course radiotherapy (GTV-P: 30 Gy/5f , CTV-P: 22.5 Gy/5 f),followed by Oxaliplatin ,Capecitabine and Tislelizumab q3w *4 cycles.Efficacy and surgery were assessed after the end of treatment.
干预措施: Tislelizumab (Drug)
Long-course radiotherapy Combined with Capecitabine and Tislelizumab
Long-course radiotherapy (50.4 Gy/25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed after the end of treatment.
干预措施: Long-course radiotherapy (Radiation)
Long-course radiotherapy Combined with Capecitabine and Tislelizumab
Long-course radiotherapy (50.4 Gy/25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed after the end of treatment.
干预措施: Capecitabine (Drug)
Long-course radiotherapy Combined with Capecitabine and Tislelizumab
Long-course radiotherapy (50.4 Gy/25 f) with concurrent Capecitabine (on radiation days) and Tislelizumab (q3w, 3cycles).Efficacy and surgery were assessed after the end of treatment.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Complete Response (CR) Rate
时间窗: t 3 months after completion of neoadjuvant therapy and up to 12 months after enrollment.
Including pCR and CCR.
次要结局
- Organ Preservation Rate(1 year.)
- 3y-OS(From enrollment to 36 month)
- Surgical Complications(Within 30 days post-surgery)
- the Quality of Life(Baseline, before surgery, and up to 12 months after surgery)
- Grade ≥3 Adverse Event Rate(From start of treatment to 30 days after last dose, up to approximately 6 months)
- 3y-DFS(From enrollment to 36 month)
- 3y-LRFS(From enrollment to 36 month)