NCT07475234尚未招募1 期
A Phase Ib/II Single-Arm, Single-Center, Prospective Clinical Study Of Rimegepant Combined With AG Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Xiuchao Wang0 个研究点目标入组 30 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This study aims to evaluate the efficacy and safety of Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer.
详细描述
This is a single-center, single-arm, prospective Phase Ib/II study designed to evaluate the clinical efficacy and safety profile of Rimegepant in combination with the AG (Nab-paclitaxel plus Gemcitabine) chemotherapy regimen as first-line treatment for patients with unresectable metastatic pancreatic cancer who have not received prior anti-pancreatic cancer therapy (surgical resection excepted).
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
- •The patient has good compliance, understands the study procedures, and has signed a written informed consent form.
- •Age ≥ 18 years.
- •Pathologically or cytologically confirmed pancreatic cancer, with imaging or pathological findings indicating unresectable pancreatic cancer with distant metastasis.
- •Patients who have not received any prior treatment for pancreatic cancer (including radiotherapy, chemotherapy, or experimental therapy), except for surgical resection.
- •If the patient has received neoadjuvant/adjuvant chemotherapy, the regimen must not contain AG, and the interval from the last administration to the diagnosis of recurrence must be >6 months, with no delayed toxicities.
- •The patient has at least one measurable lesion according to the RECIST 1.1 criteria.
- •ECOG performance status 0-
- •Expected survival >3 months.
- •Adequate organ function, defined as meeting the following criteria (blood tests to be completed within 14 days prior to enrollment):
- •Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
- •Hemoglobin ≥90 g/dL
- •Platelet count (PLT) ≥100 × 10⁹/L
- •Total bilirubin <1.5 × upper limit of normal (ULN)
- •Liver transaminases (AST & ALT) <2.5 × ULN; for patients with liver metastases, AST/ALT ≤5 × ULN
- •Serum creatinine ≤1 × ULN, or creatinine clearance ≥50 mL/min if serum creatinine >1 × ULN
- •The patient has an adequate nutritional status, defined as BMI >18.5 kg/m².
- •Female patients who are not pregnant or breastfeeding; sexually active men and women of childbearing potential must use effective contraception during the study and for 6 months after treatment completion.
- •No contraindications to remimazolam or AG chemotherapy agents.
排除标准
- •Patients with a history of other malignancies within the past 5 years, except for cured in situ carcinoma or basal cell carcinoma of the skin.
- •Patients diagnosed with pulmonary fibrosis or interstitial pneumonia within 28 days prior to enrollment.
- •Patients with refractory pleural effusion or ascites.
- •Patients with known brain or meningeal metastases.
- •Patients who used strong CYP3A4 inducers within 3 weeks prior to the first study drug administration, or strong CYP3A4/UGT1A1 inhibitors within 3 weeks prior to the first study drug administration.
- •Patients who underwent major organ surgery (excluding needle biopsy, central venous catheter insertion, port catheterization, biliary obstruction stenting, percutaneous transhepatic biliary drainage, and cholecystostomy) within 4 weeks prior to the first dose of study drug, or who plan to undergo elective surgery.
- •Patients with known dihydropyrimidine dehydrogenase deficiency or low activity.
- •Patients with active infection, including HIV infection, or chronic HBV/HCV in the active phase (HBV DNA ≥10⁴ copies/mL or ≥2000 IU/mL; patients must receive antiviral therapy first, and can only be enrolled when HBV DNA <10⁴ copies/mL or <2000 IU/mL, with continued antiviral therapy and monitoring of liver function and HBV viral load).
- •Patients with severe comorbidities, including poorly controlled diabetes despite anti-diabetic medication, clinically significant active heart disease, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, hemorrhagic peptic ulcer, ileus, or intestinal obstruction.
- •Patients with severe diarrhea (grade ≥2 per NCI-CTCAE v5.0: ≥4 bowel movements per day vs baseline; moderate/severe increase in stoma output; limitation of activities of daily living).
- •Patients with severe psychiatric disorders.
- •Patients with grade ≥II peripheral neuropathy at present or in the past.
- •Patients with known hypersensitivity to benzodiazepines, AG chemotherapy agents, or related components.
- •Patients who participated in other clinical trials within 4 weeks prior to enrollment.
- •Patients deemed unsuitable for the trial by the investigator.
研究组 & 干预措施
Single-Arm
Experimental
Patients receive Rimegepant combined with AG chemotherapy as first-line treatment for metastatic pancreatic cancer, with assessment of efficacy and safety outcomes.
干预措施: Rimegepant plus Nab-Paclitaxel and Gemcitabine (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From randomization to disease progression or death, with follow-up for up to 2 years after treatment initiation.
Time from randomization to disease progression or death from any cause, assessed per RECIST v1.1 and evaluated every 6 weeks during treatment and follow-up.
次要结局
未报告次要终点
研究者
Xiuchao Wang
Deputy Director, Pancreatic Cancer Prevention and Treatment Center
Tianjin Medical University Cancer Institute and Hospital
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