A Prospective, Phase II Study of Gemcitabine and Nab-paclitaxel in Combination With Liposomal Irinotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable/Borderline Resectable Pancreatic Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- R0 Resection Rate
研究概览
简要总结
Based on the superior efficacy and safety profile of liposomal irinotecan over irinotecan in pancreatic cancer, as well as preliminary results from earlier studies evaluating nab-paclitaxel and gemcitabine (AG) combined with liposomal irinotecan, this study aims to further evaluate the efficacy and safety of liposomal irinotecan plus AG as neoadjuvant therapy in patients with resectable or borderline resectable pancreatic cancer (RPC/BRPC). The ultimate goal is to identify a more effective treatment regimen to prolong overall survival in this patient population.
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
- 否
入选标准
- •Age ≥18 years, male or female;
- •Resectable or borderline resectable pancreatic cancer
- •No prior anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug treatment
- •At least one measurable lesion as a target lesion according to RECIST v1.1 criteria
- •ECOG performance status: 0-1
- •Expected survival time ≥3 months
- •Adequate major organ function
排除标准
- •Patients with pancreatic tumors originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary neoplasm
- •Known central nervous system (CNS) metastases
- •Severe gastrointestinal dysfunction (e.g., GI bleeding, obstruction, Grade >2 inflammation, or Grade > 1 diarrhea);
- •Symptomatic ascites requiring paracentesis or drainage, or patients who have received ascites drainage within the past 3 months (except for those with asymptomatic, controllable minimal ascites detected solely on imaging);
- •Current interstitial lung disease (ILD) or pneumonitis;
- •Known peripheral neuropathy (CTCAE Grade ≥3);
- •Coagulation dysfunction, bleeding tendency, or current thrombolytic or full-dose anticoagulant therapy.
- •Uncontrolled clinical cardiovascular symptoms or diseases；
- •Malignancy other than pancreatic cancer within 5 years prior to randomization, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin；
- •Known hypersensitivity to liposomal irinotecan, other liposomal formulations, gemcitabine, nab-paclitaxel, retlirafusp alfa injection, or any component of these products；
- •Known Acquired Immunodeficiency Syndrome (AIDS), positive HIV antibody test, or active syphilis infection；
- •History of neurological or psychiatric disorders, including epilepsy or dementia
研究组 & 干预措施
cohort 1
Neoadjuvant therapy:
liposomal irinotecan injection (II) 60mg/m²+ nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m²+ SHR-1701 1800mg every 4-week cycle,during which radical surgery will be evaluated by the investigator.
干预措施: liposomal irinotecan+nab-paclitaxel+gemcitabine (Drug)
cohort 2
Irinosome Injection (II) combined with Albumin-Bound Paclitaxel and Gemcitabine
干预措施: liposomal irinotecan+nab-paclitaxel+gemcitabine (Drug)
cohort 1
Neoadjuvant therapy:
liposomal irinotecan injection (II) 60mg/m²+ nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m²+ SHR-1701 1800mg every 4-week cycle,during which radical surgery will be evaluated by the investigator.
干预措施: SHR-1701 (Drug)
结局指标
主要结局
R0 Resection Rate
时间窗: approximately 16 to 20 weeks post-enrollment
Percentage of participants who undergo radical surgical resection and achieve an R0 margin status (defined as microscopically negative surgical margins with no tumor cells at the resection edge, \>1 mm margin clearance).
次要结局
- Resection Rate(approximately 16 to 20 weeks post-enrollment)
- pCR rate(approximately 16 to 20 weeks post-enrollment)
- EFS(Up to 18 months)
- OS(Up to 36 months)
- ORR(From enrollment to the end of neoadjuvant therapy (approximately 16 weeks))
- DCR(From enrollment to the completion of neoadjuvant therapy (approximately 16 weeks))
- safety(From baseline up to 30 days post-surgery or post-last dose)