NCT05493995已完成2 期
A Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer: PAAG.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年7月21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
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
It is a trial to assess the efficacy and safety of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as first-line Therapy in Patients (Pts) With 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
- •Ages ≥18 years，ECOG ≤ 2，Estimated survival time > 3 months
- •Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma
- •Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion
- •Patients have never received systematical anti-cancer therapy
- •Laboratory examination meets the following requirements:White blood cell (WBC) ≥3.0×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥90g/L; platelet count(PLT) ≥75×109/L; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml/min;
- •Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%
- •Patients of childbearing age should take appropriate protective measures before enrollment and during the trial
- •Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up
- •Ability to follow the study protocol and follow-up procedures.
排除标准
- •Patients have ever received any systematical anti-cancer therapy in the past
- •Patients who participated in other clinical trials in the past 4 weeks
- •According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator)
- •Patients with moderate ascites requiring drainage
- •Patients with CNS metastases and/or carcinomatous meningitis
- •Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence;
- •Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs
- •Patients with bleeding tendency.
- •Pregnant or lactating women.
- •Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study
- •Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine
研究组 & 干预措施
Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
Experimental
干预措施: Anlotinib (Drug)
Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
Experimental
干预措施: Penpulimab (Drug)
Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
Experimental
干预措施: Nab paclitaxel (Drug)
Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
Experimental
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 3 years
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1).
Disease Control Rate (DCR)
时间窗: up to 3 years
Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1.
次要结局
- Overall Survival (OS)(up to 3 years)
- Progression-free survival (PFS)(up to 3 years)
研究者
Du Juan
Clinical Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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