NCT05799443尚未招募2 期
Efficacy and Safety of SBRT Followed by Tislelizumab Plus Cetuximab and Irinotecan in Patients With Previously Treated RAS Wild-type Advanced Refractory Colorectal Cancer: a Phase II, Single-arm Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 23
- 主要终点
- Objective response rate(ORR)
研究概览
简要总结
To evaluate the efficacy and safety of SBRT followed by tislelizumab plus cetuximab and irinotecan in patients with previously treated RAS wild-type advanced refractory colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Aged 18-75 years
- •Physical Condition Score (ECOG PS) of the Eastern Cancer Cooperative Group (USA) 0 or 1;
- •Colorectal cancer diagnosed histologically and/or cytologically has metastases or relapses that are not curable by surgery
- •Have received first - and second-line systemic antitumor therapy for mCRC (chemotherapy drugs may include fluorouracil, oxaliplatin, irinotecan, e.g. XELOX, FOLFOX, FOLFIRI, FOLFOXIRI, XELIRI; Can be combined with or without targeted drugs, such as cetuximab, bevacizumab);And disease progression after second-line treatment;
- •Evaluation of lung or liver metastases can be evaluated, with stereotactic radiotherapy maneuverability;
- •At least one measurable lesion as defined in RECIST version 1.1;
- •Fertile patients must be willing to take effective pregnancy avoidance measures during the study period and ≥120 days after the last dose; Female patients with negative urine or serum pregnancy test results within 7 days or less before the first administration of the study drug;
- •Have fully understood this study and voluntarily signed informed consent.
- •Adequate organ and bone marrow function, meeting the following definitions:
- •Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment);Absolute count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥80×109/L;
- •Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor nutritional status before neoadjuvant therapy, patients who met the requirements through parenteral nutrition could also be included in the group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
排除标准
- •Pregnant or lactating women;
- •Patients with a known history of allergy to any investigative drug, similar drug or excipient;
- •Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- •Patients with a history of thromboembolism, except thrombosis caused by PICC;
- •There are patients with active infection;
- •Patients with unmanageable hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg);
- •Patients with brain metastases with clinical symptoms or imaging evidence;
- •Contraindications exist in treatment with other chronic diseases;
- •Patients with a history of immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis, etc., with current AE ≥ grade 2;
- •According to the evaluation criteria of NCI CTCAE version 5.0, there are patients with all kinds of toxicities ≥ grade 2 due to previous treatment;
- •Other conditions that the researchers determined were not suitable for inclusion in the study.
- •Received any antitumor therapy and participated in other clinical studies within 4 weeks before enrollment.
研究组 & 干预措施
SBRT followed by tislelizumab plus cetuximab and irinotecan
Experimental
干预措施: Tislelizumab (Drug)
SBRT followed by tislelizumab plus cetuximab and irinotecan
Experimental
干预措施: Irinotecan Hydrochloride (Drug)
SBRT followed by tislelizumab plus cetuximab and irinotecan
Experimental
干预措施: cetuximab (Drug)
SBRT followed by tislelizumab plus cetuximab and irinotecan
Experimental
干预措施: SBRT (Radiation)
结局指标
主要结局
Objective response rate(ORR)
时间窗: From enrollment to 12 month
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR
次要结局
- Progression-Free Survival(PFS)(From enrollment to 12 month)
- Overall Survival (OS)(From enrollment to 12 month)
研究者
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