NCT06587061招募中2 期
An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
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
- 30
- 试验地点
- 2
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
To evaluate the safety and efficacy of HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
详细描述
This study is an open, single center, exploratory clinical trial aimed at evaluating the safety and efficacy of HRS-4642 in combination with gemcitabine and albumin-bound paclitaxel for neoadjuvant and adjuvant treatment of 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 and ≤80 years old, male or female;
- •Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
- •Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •Life expectancy ≥ 12 weeks;
- •Adequate marrow and organ function;
- •Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;
- •Patients volunteered to participate in this study and signed informed consent;
排除标准
- •Previously received any anti-tumor therapy;
- •the presence of distant metastatic lesions diagnosed by imaging;
- •Known hypersensitivity to the study drug or any of its components;
- •previous or concurrent other malignant tumors;
- •Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
- •Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
- •previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
- •Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- •with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
- •with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen [HBsAg] test result at screening together with an HBVDNA test value of ≥10,000 copies/ml [2000 IU/ml]), active hepatitis C (hepatitis C virus antigen [HCV-antibodies] at screening), or active hepatitis C (hepatitis C virus antitoxin [HCV-antibodies] at screening).antibody [HCV-Ab] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;
- •Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and/or lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and/or lipase are associated with pancreatic cancer);
- •Other situations that the researcher felt should not be included.
研究组 & 干预措施
HRS-4642, Gemcitabine and Albumin-bound Paclitaxel
Experimental
HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
干预措施: HRS-4642+AG (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: From the first drug administration to within 30 days for the last dose
AEs are assessed by NCI-CTCAE v5.0
Adverse events (AEs)
时间窗: From the first drug administration to within 30 days for the last dose
AEs are assessed by NCI-CTCAE v5.0
Objective Response Rate (ORR)
时间窗: Up to approximately 6 months
Evaluated by RECIST v1.1
次要结局
- Total resection rate(At the time of surgery)
- pathologic complete response (pCR)(At the time of surgery)
- R0 resection rate(At the time of surgery)
- Overall survival (OS)(Up to approximately 12 months)
- Disease-free survival (DFS)(Up to approximately 6 months)
- Total resection rate(At the time of surgery)
- pathologic complete response (pCR)(At the time of surgery)
- R0 resection rate(At the time of surgery)
- Overall survival (OS)(Up to approximately 12 months)
- major pathologic response (MPR, CAP Score 0-1)(At the time of surgery)
- Event-free survival (EFS)(Up to approximately 6 months)
研究者
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D MutationAdvanced KRAS G12D Mutant Solid TumorsNCT06385678Jiangsu HengRui Medicine Co., Ltd.47
招募中
1 期
A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid TumorsAdvanced Solid TumorsNCT06520488Jiangsu HengRui Medicine Co., Ltd.118
终止
1 期
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic CancerPancreatic NeoplasmsPancreatic CancerNCT00529113Biogen33
进行中（未招募）
1 期
HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal AdenocarcinomaNCT06773130West China Hospital20
招募中
2 期
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.Biliary Tract CancerNCT06620848Shanghai Zhongshan Hospital49