Efficacy and Safety of Second-line Therapy by Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT in Metastatic Pancreatic Cancer Patients: a Prospective, Multicentre, Single-arm, Multi-cohort Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Objective effective rate (ORR)
研究概览
简要总结
This study is a single-arm, multi-center, multi-cohort, prospective clinical study initiated by the investigator.
The indication of this study is: patients with advanced metastatic pancreatic cancer who have progressed after first-line chemotherapy. Eligible patients will be assigned to liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT.
The total sample size for this study is expected to be 56 subjects.
详细描述
For patients with advanced metastatic pancreatic cancer who failed first-line treatment, the screening and enrollment will be completed according to the enrollment and exclusion criteria described in the study protocol, and the informed consent form will be signed after full communication. After enrollment, patients will be treated with cohort A) or cohort B), and followed up regularly.
Cohort A: nal-IRI/5-FU/LV + PD-L1 inhibitor + multi-target anti-angiogenic small molecule:
Irinotecan liposome: 50mg/m2 IV D1, D15 LV: 400mg/m2 IV D1, D15 5-FU ：2.4g/m2 CIV 46h D1, D15 bemosubaemab: 1200mg IV Q3W Anlotinib: 12mg po D1-D14 Q3W
Cohort B: nal-IRI/5-FU/LV + PD-L1 inhibitor+ multi-target anti-angiogenic small molecule+SBRT Group:
Irinotecan liposomes: 50mg/m2 IV D1, D15 LV: 400mg/m2 IV D1, D15 5-FU ：2.4g/m2 CIV 46h D1, D15 bemosubaemab: 1200mg IV Q3W Anlotinib: 12mg po D1-D14 Q3W SBRT
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
- •Age ≥ 18 years and ≤ 75 years, ECOG score of ≤2 points, expected survival time ≥ 3 months.
- •Patients with histologically or cytologically confirmed advanced metastatic pancreatic cancer.
- •Imaging suggests distant measurable lesions.
- •Failure of first-line therapy and no use of fluorouracil, irinotecan, or liposomal irinotecan drugs in the first-line therapy.
- •Patients need to meet the following hematologic indicators e
- •Neutrophil count ≥ 1.5×109/L e
- •Hemoglobin ≥ 10 g/dL e
- •Platelet count ≥ 100×109/L f. Patients need to meet the following biochemical parameters f
- •Total bilirubin ≤ 1.5× upper limit of normal (ULN) f
- •AST and ALT <1.5×ULN f
- •Creatinine clearance ≥ 60ml/min g. Patients of childbearing age need to take appropriate protective measures (contraception or other methods of birth control) before enrollment and during the trial.
- •H. Has signed an informed consent form. i. Able to follow the study protocol and follow-up process.
排除标准
- •Have received second-line or more anti-tumor therapy in the past.
- •First-line treatment with fluorouracil, irinotecan or liposomal irinotecan, etc.
- •Patient has a prior history of other tumors, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumors (Ta and TIS) or other malignancies that have received curative therapy (at least more than 5 years prior to enrollment).
- •Patient has an active bacterial or fungal infection (≥ 3rd edition NCI-CTC2 grade).
- •Patient has HIV, HCV, HBV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or other disease deemed non-enrollable by the investigator.
- •f. Patients with autoimmune diseases or immunodeficiencies who should be treated with immunosuppressive drugs.
- •g. Pregnant and lactating women. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
- •h. Substance abuse, clinical or psychological, or social factors that compromise informed consent or study conduct.
- •i. Those who may be allergic to treatment drugs.
研究组 & 干预措施
nal-IRI/5-FU/LV + benmelstobart + anlotinib ± SBRT
liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU)/leucovorin (LV) (nal-IRI/5-FU/LV) combined with benmelstobart and anlotinib ± SBRT
干预措施: nal-IRI,5-fu,LV, benmelstobart, anlotinib (Drug)
结局指标
主要结局
Objective effective rate (ORR)
时间窗: 28 days per cycle, with ≤6 cycles of treatment expected per patient
The overall response rate, including complete response (CR) + partial response (PR), refers to the proportion of patients whose tumor shrinks to a certain amount and remains for a certain period of time.
次要结局
- Disease control rate (DCR)(28 days per cycle, with ≤6 cycles of treatment expected per patient)
- Median overall survival (mOS)(28 days per cycle, with ≤6 cycles of treatment expected per patient)
- Median progression-free survival (mPFS)(28 days per cycle, with ≤6 cycles of treatment expected per patient)