Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Progression-free survival（PFS）
研究概览
简要总结
This is a multi-center, open-label， randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.
详细描述
This study is a multi-center, open-label, randomized controlled Phase II clinical study to evaluate the efficacy and safety of penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer, and to explore the clinical indicators related to efficacy to guide the individualized treatment.
Trial group:
Nab-paclitaxel 125mg/m2 I.V. D1,8 Gemcitabine 1.0g/m2 I.V. D1,8 Penpulimab 200mg IV D1 Anlotinib 12mg/10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2)
Control group:
Nab-paclitaxel 125mg/m2 I.V. D1,8 Gemcitabine 1.0g/m2 I.V. D1,8
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
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
Trial group
penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
干预措施: Penpulimab (Drug)
Trial group
penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
干预措施: Anlotinib (Drug)
Trial group
penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
干预措施: Nab paclitaxel (Drug)
Trial group
penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
干预措施: Gemcitabine (Drug)
Control group
AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
干预措施: Nab paclitaxel (Drug)
Control group
AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Progression-free survival（PFS）
时间窗: up to 1 years
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Objective Response Rate (ORR)(up to 1 years)
- Disease Control Rate (DCR)(up to 1 years)
- Overall Survival (OS)(up to 2 years)