Neoadjuvant Chemotherapy and Tislelizumab (PD-1 Inhibitior) for Locally Advanced Rectal Cancer: a Single-center, Prospective, Phase II Study
概览
- 阶段
- 2 期
- 干预措施
- Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles
- 疾病 / 适应症
- Rectal Cancer Patients
- 发起方
- The Affiliated Hospital of Qingdao University
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Clinical complete response and pathological complete response
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.
详细描述
Treatment will continue until participants experiences disease progression, unacceptable toxicity or withdraws consent and will include chemotherapy and PD-1 inhibitor (Tislelizumab) x 3 cycles (9 weeks). For participants experiencing unacceptable CAPOX or Tislelizumab related toxicity, yet obtaining therapeutic benefit, participants will be allowed to continue treatment, if well tolerated at the discretion of the investigator.After the completion of 3 cycles of treatment, the patients will rest for 2 weeks and then undergo surgery, and adjuvant therapy will be decided according to the postoperative pathology. Upon discontinuation of study treatment, participants will receive safety follow-up assessments approximately 30 and 90 days later. Once the 90-day safety follow-up is complete, participants will enter the survival follow-up period where they will continue to be followed approximately every three months until death, withdrawal of consent, or overall study completion. Patients will be followed for survival for 36 months from enrollment.
研究者
入排标准
入选标准
- •Be willing and able to provide written informed consent for the trial
- •Age 18 years or greater
- •Pathologically proven diagnosis of adenocarcinoma of the rectum
- •Clinically determined to be stage T3 or T4, N0-N2, and M0
- •Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity.
- •Contrast-enhanced imaging of the abdomen and chest by CT to exclude distant metastases and provide local tumor stage
- •Preoperative ECOG status score 0-1
- •Preoperative ASA grade I-III
- •Adequate bone marrow function
- •Adequate renal and liver function
排除标准
- •Age less than 18 years
- •Pregnant or breastfeeding women
- •Prior invasive malignancy unless disease free for a minimum of three years
- •Preoperative body temperature ≥ 38°C or concurrent infectious diseases requiring systemic therapy;
- •Severe mental illness;
- •Severe abnormal heart, lung and kidney function
- •History of unstable angina pectoris or myocardial infarction within 6 months;
- •History of cerebral infarction or cerebral hemorrhage within 6 months;
- •Patients with abnormal coagulation function;
- •Have a history of psychotropic drug abuse or have a mental disorder;
研究组 & 干预措施
Patients with rectal cancer receiving neoadjuvant chemotherapy and PD-1 inhibitor
Experimental: Combination of drugs prior to surgery Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three to four years. The time in the study will take approximately four - six hours during pre-study, study and end of study visits.
干预措施: Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles
结局指标
主要结局
Clinical complete response and pathological complete response
时间窗: The cCR was evaluated at 8 weeks after neoadjuvant chemotherapy. The pCR was evaluated after surgery.
The cCR is judged by imaging (CT/MRI), tumor markers, and colonoscopy. The pCR is examined by pathological examination.