2025-522120-28-00招募中2 期
Total Neoadjuvant Treatment with or without Tislelizumab for Locally Advanced Rectal Cancer: An Open-label Randomized Controlled Phase II Study (The TOTAL Trial)
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Rabin Medical Center5 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2026年2月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 5
- 主要终点
- The primary endpoint is the 3-year TME-free survival rates (intention to treat, ITT)
研究概览
简要总结
To compare the 3-year TME-free survival of the investigational and the standard regimens
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects with histologically confirmed primary (non-recurrent) LARC (tumor ≤<12 cm from the anal verge, as assessed by rigid proctoscopy), stage II (T3-4 N0 M0) or stage III (TX N1-2 M0) according to base-line pelvic MRI and PET-CT.
- •Adequate contraception in fertile patients; using a highly effective method of birth control for the duration of the study, and for at least 9 months after the last dose of chemotherapy and 120 days after the last dose of immunotherapy.
- •Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to the start of treatment.
- •Women must not be breastfeeding.
- •Signed written IRB approved informed consent. This must be obtained before the performance of any protocol related procedure that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatments, and laboratory testing.
- •Patients who are planned for TNT (total neoadjuvant treatment) and are surgical candidates as determined by the treating physician.
- •No prior chemotherapy, immunotherapy, radiotherapy or surgery for rectal cancer.
- •No prior radiotherapy to the pelvis, for any reason.
- •Able to provide the FFPE block or 10 unstained slides from the colonoscopy for confirmation of the diagnosis, CPS (PD-L1 combined positive score) status and for investigational purposes.
- •Age ≥ > 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) <
- •Screening laboratory values must meet the following criteria (using CTCAE v5.0): i) WBC ≥ 2000/µL ii) Neutrophils ≥ 1500/ µL iii) Platelets ≥ 100 x 10^3 µL iv) Hemoglobin ≥ 9.0 g/dL v) Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (using the Cockcroft Gault formula) vi) AST and ALT ≤ 2.5 x ULN vii) Total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome)
- •Ability to swallow tablets.
排除标准
- •Active or background history of an autoimmune disease except for type I diabetes mellitus, hypothyroidism requiring hormone replacement only and skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.
- •Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •Known acute hepatitis B, known chronic hepatitis B infection with active untreated disease, or known active hepatitis C infection. In participants with a history of HBV or HCV, participants with detectable viral loads will be excluded.
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment
- •Patients with mismatch repair deficient (MMRd) / microsatellite instability- high (MSI-H) tumors.
- •Any evidence of interstitial lung disease or active, noninfectious pneumonitis
- •Medical history of vasculitis.
- •Prior organ transplant, including allogenic bone marrow transplantation.
- •Grade > 1 peripheral sensory neuropathy.
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •Any prior active malignancy ≤ 2 years before trial entry except for any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
- •Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive protocol therapy.
结局指标
主要结局
The primary endpoint is the 3-year TME-free survival rates (intention to treat, ITT)
The primary endpoint is the 3-year TME-free survival rates (intention to treat, ITT)
次要结局
- 3-year TME-free survival (CPS≥1%)
- cCR
- DFS
- PFS
- OS rates
- safety and toxicity profile
- patient-reported functional outcomes and QoL (quality of life) with EORTC QLQ-C30 and CR-29
研究者
Sponsor contact point clinical trials
Scientific
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
研究点 (5)
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