临床试验/NCT06379399

NCT06379399招募中1 期

Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type Metastatic Colorectal Cancer: A Single-center, Prospective Phase Ib/II Study

Wangxia LV1 个研究点分布在 1 个国家目标入组 26 人开始时间: 2024年4月最近更新: 2024年4月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 26
试验地点: 1
主要终点: Progression-free survival (PFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic 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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient able and willing to provide written informed consent and to comply with the study protocol and follow-up inspection.
•Histologically or cytologically confirmed metastatic adenocarcinoma of the colon; excluding appendiceal and anal canal cancers.
•Previously received at least second-line treatment, including two standard treatment regimens (such as fluoropyrimidine, capecitabine, irinotecan, oxaliplatin with or without anti-VEGF or anti-EGFR agents), if previously received first-line anti-EGFR therapy, achieving at least a partial response (PR) or above, with a discontinuation interval of at least one year.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-
•Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) (based on RECIST 1.1 criteria, with the longest diameter of tumor lesions on CT/MRI scan ≥10mm, and the shortest diameter of lymph node lesions on CT/MRI scan ≥15mm).
•Wild-type RAS/BRAF gene detected.
•Able to take oral medication.
•Normal organ function, meeting the following criteria within 14 days before treatment initiation:
•Neutrophil count ≥1.5×10^9/L;
•Platelet count ≥75×10^9/L;
•Hemoglobin ≥9.0g/dL;
•Aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN) (or ≤5×ULN if liver metastases);
•Alanine aminotransferase (ALT) ≤2.5×ULN (or ≤5×ULN if liver metastases);
•Total bilirubin ≤1.5×ULN;
•Creatinine clearance (calculated by Cockcroft and Gault formula) >60mL/min or serum creatinine ≤1.5×ULN;
•Expected survival time >3 months (90 days).
•Women of childbearing potential must have used reliable contraception for 7 days prior to enrollment, have had a negative pregnancy test, and agree to use appropriate contraception methods during the trial and for 6 months after the last dose of investigational drug. Men must agree to use appropriate contraception methods or have undergone surgical sterilization during the trial and for 6 months after the last dose of investigational drug.

排除标准

•Prior treatment with Trifluridine/Tipiracil;
•Patients with known dMMR or MSI-H advanced colorectal cancer who have not previously received anti-PD-1 or PD-L1 inhibitors;
•Participation in another drug clinical trial or receipt of systemic chemotherapy, radiotherapy, or biologic therapy within the past 4 weeks;
•Known or suspected brain metastases;
•Synchronous or metachronous cancer with a disease-free survival of ≥5 years (except for colorectal cancer) excluding cured or curatively treated mucosal cancers (esophageal cancer, gastric cancer, cervical cancer, non-melanoma skin cancer, bladder cancer, etc.);
•Factors significantly affecting oral drug absorption, such as dysphagia, chronic diarrhea, and gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;
•Symptomatic malignant effusion requiring symptomatic treatment (including pleural effusion, ascites, pericardial effusion);
•Pregnant or lactating women; patients with reproductive potential unwilling or unable to use effective contraceptive measures;
•Known allergy to the investigational drug, drug class, or its components;
•Requirement for systemic corticosteroid therapy (excluding local steroids and cetuximab pre-treatment);
•History of interstitial lung disease (interstitial pneumonia, pulmonary fibrosis, etc.) or radiographic evidence of interstitial lung disease;
•Active local or systemic infections requiring treatment;
•New York Heart Association (NYHA) functional classification ≥II or severe heart disease;
•Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or history of active hepatitis B or hepatitis C;
•Unresolved toxicity (CTCAE>Grade 1) or incomplete recovery from previous cancer surgery.
•Patients deemed unsuitable for the study by the investigator.

研究组 & 干预措施

Cetuximab Combined With Trifluridine/Tipiracil

Experimental

干预措施: Cetuximab (Drug)

Cetuximab Combined With Trifluridine/Tipiracil

Experimental

干预措施: Trifluridine/Tipiracil (Drug)

结局指标

主要结局

Progression-free survival (PFS)

时间窗: Approximately 12 months

Progression-free survival defined as the time elapsed between the randomization and the date of radiologic tumour progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first.

次要结局

Disease Control Rate( DCR)(Approximately 12 months)
Adverse Events(safety)(Up to 28 days after discontinuation of study drug or start of subsequent therapy.)
Overall survival (OS)(Approximately 12 months)
Overall Response Rate (ORR)(Approximately 12 months)
Quality of life: EORTC QLQ-C30(Approximately 12 months)

研究者

发起方

Wangxia LV

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Wangxia LV

Deputy Director of Colorectal Medicine

Zhejiang Cancer Hospital

研究点 (1)

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