NCT07523763进行中（未招募）2 期
Phase II Open-label Non-randomized Study of Neoadjuvant Low-dose Immunotherapy in Patients With Locally Advanced Colorectal Cancer With Microsatellite Instability (MSI)/Mismatch Repair Deficiency (dMMR)
Blokhin's Russian Cancer Research Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete response (pathological complete response - pCR + durable clinical complete response - cCR)
研究概览
简要总结
Patients with clinical stage II-III dMMR/MSI colorectal adenocarcinoma will be treated with low-dose immunotherapy: nivolumab 100 mg or pembrolizumab 100 mg. The duration of treatment is 6 months.
详细描述
Patients with clinical high risk stage II (T3 with extramural extension ≥ 5mm or T4), stage III dMMR/MSI CRC will be treated with low-dose immunotherapy: nivolumab 100 mg every 2 weeks or pembrolizumab 100 mg every 4 weeks, then will be underwent surgery after 6 months of immunotherapy. Pts who refuse surgery and/or in case of complete clinical response (cCR) will continue therapy up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of voluntarily signed informed consent from the patient
- •Histologically confirmed adenocarcinoma of the colon or rectum;
- •Locally advanced tumor - cT3-4N0-2M0 according to CT for tumors of the colon and sigmoid colon; cT3 with a depth of tissue invasion ≥5mm (cT2N0 and higher for lower ampullary cancer) or T4 or involvement of the lateral resection margins according to MRI for rectal cancer;
- •Presence of MSI/dMMR in the tumor;
- •ECOG 0-2;
- •No contraindications to surgical treatment of malignancy
排除标准
- •Previous therapy with the inclusion of monoclonal antibodies - anti-PD1, anti-PD-L1, anti PD-L2, anti-CTLA4 antibodies and other immunotherapy drugs
- •The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study
- •Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy
- •Patients with preserved reproductive potential who refuse to use adequate methods of contraception throughout the study and 6 months after the end of therapy or who agree to abstain from heterosexual contact.
- •Previous systemic therapy with immunosuppressive drugs (including, but not limited to: prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF [tumor necrosis factor] antagonists) within 4 weeks before signing the informed consent form, or the need to use immunosuppressive therapy in during the first year of the study.
- •The use of systemic glucocorticosteroids (GCS) in replacement doses (for example, in a dose equivalent to 10 mg of prednisolone per day or less), short-term use of systemic GCS (≤7 days), inhaled and topical GCS are allowed.
- •Active, known or suspected autoimmune diseases (patients with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as autoimmune diseases with only skin manifestations [for example, vitiligo, alopecia or psoriasis without symptoms of psoriatic arthritis] are allowed to participate), that do not require systemic therapy);
- •Patients with HIV infection, active hepatitis B, active hepatitis C.
- •Life expectancy less than 6 months.
- •The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study.
- •Complicated course of the primary tumor, requiring urgent surgical intervention.
- •Previously performed radiation or chemotherapy for colorectal cancer, with the exception of cases of metachronous tumors over 5 years ago;
- •Persistence, progression or recurrence of the underlying disease or the presence of distant metastases
- •Conditions limiting the patient's ability to comply with the requirements of the protocol (in the opinion of the investigator);
- •Vaccination with live vaccines within 28 days before randomization;
- •Participation in other interventional clinical trials less than 30 days before randomization (except in cases of dropout before the introduction of study therapy) and while participating in an ongoing clinical trial;
- •Significant adverse events from previous therapy, with the exception of chronic and/or irreversible events that cannot influence the assessment of the safety of the study therapy (for example, alopecia);
- •Hypersensitivity or allergic reactions to the administration of drugs manufactured using Chinese hamster ovary cells, severe allergic reactions, anaphylaxis or other hypersensitivity reactions to chimeric or humanized antibodies, or any of the components of the study drug.
研究组 & 干预措施
Nivolumab
Experimental
The patients will be treated with nivolumab 100 mg every 2 weeks during 6 months until surgery
干预措施: Nivolumab (Drug)
Pembrolizumab
Experimental
The patients will be treated with pembrolizumab 100 mg every 4 weeks during 6 months until surgery
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Complete response (pathological complete response - pCR + durable clinical complete response - cCR)
时间窗: up to 8 months
pCR: absence of malignant cells on the specimen of colon/rectal resection in patients who were previously treated with neoadjuvant immunotherapy cCR: absence of detectable tumor via endoscopy and MRI up to 6 months
次要结局
- Major pathologic response (MPR)(up to 8 months)
- Durable complete clinical response rate (DRR)(up to 12 months)
- Progression-free survival (PFS)(12 months)
- Overall survival (OS)(12 months)
- Objective response rate (ORR)(up to 8 months)
- Incidence of Treatment-Related Adverse Events as assessed by investigator(up to 6 months)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A Study to Test Chemotherapy with Low-Dose Immunotherapy Before Surgery in Treatable Lung CancerCTRI/2025/02/081029Tata Memorial Centre53
招募中
不适用
Data registry for patients with rectal cancer treated with radiation and chemotherapy undergoing non operative managementCTRI/2024/10/074809Tata Memorial Hospital337
进行中（未招募）
3 期
在晚期 / 转移性胃食管腺癌患者中评估 MK-2870 的 III 期研究胃食管癌CTR20242332默沙东研发（中国）有限公司
尚未招募
2 期
A Single-arm Clinical Study Evaluating Pirfenidone and Sintilimab in Combination With Standard Neoadjuvant Chemotherapy for Colorectal Cancer Patients With Peritoneal Metastasis.Colorectal CancerNCT07268677Guoxiang Cai30
招募中
2 期
Neoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab2024-517119-59-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting38