NCT06001658招募中2 期
Tumor Microenvironment Features of Response to Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年7月8日最近更新:
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
- 27
- 试验地点
- 1
- 主要终点
- Average minimum Euclidean distance from CD8+ T cells to immunosuppressive tumor-associated macrophages (TAMs) at the per-cell level in patients with a major pathologic response versus pathologic non-responders.
研究概览
简要总结
The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.
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
- •Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma.
- •Resectable BTC (biliary tract cancer)
- •Measurable disease per RECIST 1.1 as determined by the investigator.
- •Age ≥18 years.
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤1 or Karnofsky ≥80
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •Patients must have adequate liver function defined by study-specified laboratory tests.
- •Patients with chronic or acute HBV or HCV infection must have disease controlled prior to enrollment.
- •Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
- •For both Women and Men, must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Receiving, or previously received, any systemic chemotherapy, or investigational agent for BTC.
- •Has received prior radiotherapy within 2 weeks of start of study intervention.
- •Patients with a history of prior treatment with anti-PD-1 and anti-PD-L
- •Have been diagnosed with another cancer or myeloproliferative disorder whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this study's investigational drugs.
- •Has a known history of Human Immunodeficiency Virus (HIV)/AIDS
- •Has active co-infection with HBV and HDV.
- •Has a diagnosis of immunodeficiency.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years.
- •Systemic or topical corticosteroids at immunosuppressive doses.
- •Prior allogeneic stem cell transplantation or organ transplantation.
- •Prior tissue or organ allograft or allogeneic bone marrow transplantation, including corneal transplants.
- •Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.
- •Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Evidence of clinical ascites.
- •Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- •Previously identified allergy or hypersensitivity to monoclonal antibodies or any component of the study treatment formulations.
- •Pregnant or breastfeeding.
- •WOCBP and men with female partners (WOCBP) who are not willing to use contraception.
- •Subjects unable to undergo venipuncture and/or tolerate venous access.
- •Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
研究组 & 干预措施
Gemcitabine, Cisplatin and Pembrolizumab
Experimental
干预措施: Gemcitabine (Drug)
Gemcitabine, Cisplatin and Pembrolizumab
Experimental
干预措施: Cisplatin (Drug)
Gemcitabine, Cisplatin and Pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Average minimum Euclidean distance from CD8+ T cells to immunosuppressive tumor-associated macrophages (TAMs) at the per-cell level in patients with a major pathologic response versus pathologic non-responders.
时间窗: 4 years
The evaluable population of this endpoint consist of all patients who receive at least one dose of study drug and have TAMs and CD8 T cell measures at the time of surgery. TAMs being evaluated are the following: immunosuppressive TAMs with high Arginase-1 expression (CD68+CD163+Arg-1hiPDL1-/+), immunosuppressive TAMs with low Arginase-1 expression (CD68+CD163+Arg-1lo PDL1-/+), and less immunosuppressive TAMs (CD68+CD163-HLA-DRhi/CD86hi/PDL1hi)
次要结局
- Number of participants experiencing grade 3 or above drug-related toxicities(4 years)
- Number of patients proceeding to surgery without an extended treatment-related delay as a measure of feasibility(144 days)
- R0 resection rate(60 days)
- Major pathologic response rate(8-12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By SurgeryPancreatic CancerNCT00335543Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft254
已完成
2 期
Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic CancerPancreatic CancerNCT01150630IRCCS San Raffaele98
已完成
2 期
Gemcitabine or Combination Chemotherapy Followed by Chemoradiation for Stage IB, II, or III Pancreatic CancerPancreatic CancerNCT00960284IRCCS San Raffaele102
已完成
1 期
preoperative gemcitabine based chemoradiation therapy for resectable and borderline resectable pancreatic cancer phase1 studyresectable and borderline resectable pancreatic cancerJPRN-UMIN000020977fukushima medical university30
Unknown
1 期
Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With IrinotecanColorectal CancerNCT00496704Yonsei University56