NCT06951997招募中2 期
Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chidamide, Albumin-bound Paclitaxel and Gemcitabine as First-line Treatment for Metastatic Pancreatic Cancer
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年3月7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
- 招募中
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a single-center, open-label, exploratory study aims to assess the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment for patients with metastatic pancreatic adenocarcinoma.
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
- •Understand and voluntarily sign the informed consent form for this study
- •Age ≥18 years and ≤ 75 years, ale or Female
- •Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer)
- •No prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received
- •At least one measurable lesion on imaging according to RECIST 1.1
- •ECOG score 0-1
- •Expected survival time ≥3 months
- •Adequate organ function, subjects must meet the following laboratory criteria:Platelet count ≥90x10^9/L,White blood cell count ≥ 3.5 × 10⁹/L,Absolute neutrophil count (ANC) ≥1.5x10^9/L,Hemoglobin > 90g/L,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,Total bilirubin ≤ 1.5 ULN,Urea/Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL/min),Left ventricular ejection fraction (LVEF) ≥ 50%,QTcF interval (Fridericia correction) < 470 ms
- •Fertile women/non-sterilized men must use effective contraception
排除标准
- •Inability to comply with the study protocol or procedures
- •patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors
- •Known presence of germline BRCA1/2 mutations
- •patients with known central nervous system metastases
- •Hypersensitivity or allergic predisposition to the study drug or its excipients
- •Concurrent use of any other investigational drug or participation in another clinical trial involving investigational therapy within 4 weeks
- •Major surgery, severe traumatic injury, fractures, or ulcers within 6 weeks before study
- •History of gastrointestinal perforation or fistula within 6 months before the first dose. Subjects may be enrolled if the perforation/fistula has been surgically repaired and the investigator confirms resolution
- •Clinically significant gastrointestinal disorders, including obstruction (including partial), dysphagia, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other conditions severely affecting nutrient absorption
- •Clinically significant bleeding or clear bleeding tendency within 1 month before the first dose, e.g.,gastrointestinal bleeding, hemorrhagic gastric ulcer
- •Any of the following concurrent conditions:(1) Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure(2) Severe uncontrolled concurrent infection causing disability(3) Proteinuria ≥ 2+ (≥1.0 g/24 h)(4) Bleeding tendency or history within 2 months before enrollment, regardless of severity(5) Arterial/venous thromboembolic events within 12 months before treatment (e.g., cerebrovascular accident, transient ischemic attack)(6) Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment(7) Unhealed fractures or chronic wounds(8) Coagulopathy, bleeding tendency, or ongoing anticoagulation therapy
- •History of other malignancies within 5 years before enrollment, except for adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ
- •Any cardiovascular or cerebrovascular disease or risk factors
- •Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment
- •Prior allogeneic bone marrow or solid organ transplantation
- •Unresolved toxicities (> CTCAE v5.0 Grade 1) from prior anticancer therapy, except alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity (≤ Grade 2)
- •Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1/CTLA-4 antibodies), immune checkpoint agonists (e.g., anti-ICOS/CD40/CD137/GITR/OX40 antibodies), or immune cell therapy (e.g., CAR-T)
- •Systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before the first dose
- •Known interstitial lung disease (ILD) or non-infectious pneumonitis (either symptomatic or requiring systemic steroids)
- •Any other clinically significant condition, metabolic disorder, physical/lab abnormality, epilepsy requiring treatment etal
- •Pregnant or breastfeeding women
- •Any other condition deemed unsuitable for study participation by the investigator
研究组 & 干预措施
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine
Experimental
QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
干预措施: QL1706 (Drug)
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine
Experimental
QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
干预措施: Chidamide (Drug)
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine
Experimental
QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
干预措施: Gemcitabine (Drug)
QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine
Experimental
QL1706 5mg/kg，Q3W; Gemcitabine 1000mg/m2 Q3W；Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w;
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
overall response rate
次要结局
- Duration of Response (DOR)(2 year)
- OS(2 year)
- AEs(2 year)
- Progression-free Survival (PFS)(2 year)
- Disease Control Rate (DCR)(2 year)
研究者
研究点 (1)
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