NCT06356597进行中（未招募）2 期
Division of Gastroenterology and Hepatology,Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Jing-yuan Fang, MD, Ph. D2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年4月19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
- 33
- 试验地点
- 2
- 主要终点
- PFS
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Tislelizumab with Fruquintinib, Metronidazole treatment in MSS/MSI-L advanced colorectal cancer patients with high abundance of Fusobacterium nucleatum in a single arm Phase II clinical.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No gender limit, age ≥ 18 years old and ≤ 80 years old
- •Colorectal cancer (AJCC stage IV) diagnosed by histological or cytological biopsy as metastatic or unresectable, with immunohistochemical or genetic testing indicating MSS or MSH-L type
- •Treatment requires third line or above, has previously received standard first and second line treatment, and the disease has progressed after treatment
- •Before accepting tirelizumab, qPCR should be used to detect the Fn CT value < 35 in fecal samples, and Fn is confirmed positive by agarose gel electrophoresis or Sanger sequencing
- •ECOG score: 0-1 points
- •Baseline blood routine and biochemical indicators meet the following criteria (no blood transfusion or use of colony stimulating factors 2 weeks prior to screening) Blood routine: hemoglobin ≥ 90g/L, absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet ≥ 100 × 109/L Liver function: ALT and AST ≤ 2.5 x ULN, serum total bilirubin ≤ 1.5 x ULN (if there is liver metastasis, ALT and AST ≤ 5 x ULN, serum total bilirubin ≤ 3 x ULN), serum albumin ≥ 30g/L Renal function: serum creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance rate ≥ 50 mL/min (calculated according to Cockcroft Gault formula).
- •Those who voluntarily participate in the trial and sign an informed consent form.
排除标准
- •Pregnant or lactating women;
- •Chronic intestinal diseases (such as Crohn's disease, ulcerative colitis, etc.), infectious intestinal diseases during the screening period, and intestinal obstruction during the screening period;
- •Subjects with poor control of hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg) and a history of hypertensive crisis or hypertensive brain disease;
- •Severe liver and kidney function or heart dysfunction;
- •Patients who use antibiotics for more than 5 days within one month prior to immunotherapy;
- •Patients with known brain or meningeal metastases, regardless of whether they have received treatment, are not eligible for inclusion in this trial.
- •Individuals with contraindications to the use of metronidazole medication;
- •Those who are unwilling to participate in the trial or sign informed consent forms;
- •The researchers believe that there are any situations that are not suitable for selection.
研究组 & 干预措施
Tislelizumab with Fruquintinib, Metronidazole
Experimental
干预措施: Tislelizumab with Fruquintinib, Metronidazole (Drug)
结局指标
主要结局
PFS
时间窗: The time from when the patient first receives immunotherapy and Metronidazole to the earliest evidence of disease progression，or date of death from any cause, whichever came first, assessed up to 100 months.
Progression-Free-Survival
次要结局
- ORR(The proportion of patients whose tumor volume has shrunk to a predetermined value (usually 30%) and can maintain the minimum time limit requirement is the sum of complete remissionand partial remission.)
- OS(The time from when the patient first receives immunotherapy and Metronidazole to death, assessed up to 100 months.)
- DCR(The proportion of patients whose tumors have achieved remission (PR+CR) and disease stability (SD, tumor shrinkage has not reached 30% but has not progressed) after treatment.)
研究者
Jing-yuan Fang, MD, Ph. D
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai Jiao Tong University School of Medicine
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver MetastasesColo-rectal CancerNCT06218888Fujian Cancer Hospital17
Unknown
2 期
Tislelizumab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With Advanced CRCPatients With Advanced Metastatic Colorectal CancerNCT04924179Huazhong University of Science and Technology25
尚未招募
2 期
Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal CancerRectal CancerNCT06443671Peking University Cancer Hospital & Institute132
Unknown
2 期
Fruquintinib Plus PD-1 Antibody in pMMR / MSS Locally Advanced Rectal Cancer (LARC) With High Immune ScoreLocally Advanced Rectal CancerNCT04989855Sun Yat-sen University48
招募中
2 期
Fruquintinib Combined With Sintilimab and Chemotherapy in the Treatment of Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT04956146The First Affiliated Hospital with Nanjing Medical University46