NCT07110064招募中2 期
Iparomlimab and Tuvonralimab Injection (QL1706) in Combination With Lenvatinib and AG Regimen as First-line Treatment for Advanced Metastatic Pancreatic Cancer:A Prospective, Single-Arm, Multicenter, Phase II Clinical Study
Du Juan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月3日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Median Progression-Free Survival (mPFS)
研究概览
简要总结
The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 80 patients with advanced pancreatic cancer who have not received prior treatment. This study aims to enhance the anti-tumor immune effect through the combination of QL1706+Lenvatinib+AG regimen, thereby improving the prognosis of patients with advanced metastatic pancreatic 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
- •a. Age ≥18 years, ECOG performance status ≤2, and expected survival of ≥3 months.
- •b. Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer.
- •c. At least one measurable lesion according to RECIST 1.1 criteria;
- •d. No prior anti-tumor treatment of any kind.
- •e. Patients must meet the following hematological criteria: e
- •White blood cell count (WBC) ≥3.0×10^9/L; e
- •Absolute neutrophil count (ANC) ≥1.5×10^9/L; e
- •Hemoglobin (HB) ≥90 g/L; e
- •Platelet count (PLT) ≥75×10^9/L; e
- •Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); e
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; if there is liver metastasis, then ALT and AST ≤5×ULN; e
- •Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr) ≥50 ml/min;
- •f. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
- •g. Patients of childbearing potential must take appropriate protective measures (contraception or other methods of fertility control) before enrollment and during the study.
- •h. Willingness to participate in the study, with signed informed consent, good compliance, and cooperation with follow-up; able to adhere to the study protocol and follow-up procedures.
排除标准
- •a. Prior receipt of systemic anti-tumor treatment, such as chemotherapy, radiotherapy, or other anti-tumor treatments.
- •b. Participation in another drug clinical trial within the past 4 weeks.
- •c. Subjects who, in the investigator's judgment, have the opportunity for surgery or are potentially operable (subjects who voluntarily forgo surgical treatment may be enrolled after investigator assessment and agreement).
- •d. Subjects with moderate ascites requiring drainage (except for those with minimal ascites shown on imaging without symptoms).
- •e. Known symptomatic central nervous system metastases and/or carcinomatous meningitis.
- •f. History of other primary malignancies, except for the following: 1) Malignancies that have been in complete remission for at least 2 years prior to enrollment and do not require other treatments during the study; 2) Non-melanoma skin cancer or malignant lentigo that has been adequately treated and shows no evidence of disease recurrence; 3) Carcinoma in situ that has been adequately treated and shows no evidence of disease recurrence.
- •g. Patients with autoimmune diseases or immune deficiencies who are being treated with immunosuppressive drugs.
- •h. Patients with a tendency to bleed.
- •i. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
- •j. Drug abuse, or clinical, psychological, or social factors that may affect informed consent or study implementation.
- •k. Subjects who may be allergic to epaltrastide (QL1706), lenvatinib, albumin-bound paclitaxel, or gemcitabine.
研究组 & 干预措施
QL1706+Lenvatinib+AG Regimen
Experimental
干预措施: QL1706+Lenvatinib+AG Regimen (Drug)
结局指标
主要结局
Median Progression-Free Survival (mPFS)
时间窗: up to 24 months
次要结局
- Objective Response Rate (ORR)(up to 24 months)
- Disease Control Rate (DCR)(up to 24 months)
- Median Overall Survival (mOS)(up to 24 months)
- Adverse Events（AEs）(up to 36 months)
研究者
Du Juan
Nanjing Drum Tower Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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