NCT02844075已完成2 期
A Phase II Trial of Preoperative Chemoradiotherapy and MK-3475 for Esophageal Squamous Cell Carcinoma (ACTS-29)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Complete Pathologic Response Rate
研究概览
简要总结
In this study, participants with esophageal squamous cell carcinoma will receive preoperative chemoradiotherapy with paclitaxel,carboplatin and pembrolizumab then undergo surgery. The primary study hypothesis is that adding pembrolizumab will increase complete pathologic response rate at surgery.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed ESCC
- •Clinical stage T1N1-2 or T2-34aN0-12 (AJCC 7 TNM classification)
- •No evidence of metastasis
- •Be willing and able to provide written informed consent/assent for the trial.
- •Be 20 years of age on day of signing informed consent.
- •Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day
- •Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
- •Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
- •Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female subjects of childbearing potential (Section 5.7.2) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 120 days after the last dose of study medication.
- •Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- •Male subjects of childbearing potential (Section 5.7.1) must agree to use an adequate method of contraception as outlined in Section 5.7.1- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
排除标准
- •Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •Has a known history of active TB (Bacillus Tuberculosis)
- •Hypersensitivity to pembrolizumab or any of its excipients.
- •Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- •Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •Has another malignancy within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative surgery, or in situ cervical cancer.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •Has known history of, or any evidence of active, non-infectious pneumonitis.
- •Has an active infection requiring systemic therapy.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- •Has received a live vaccine within 30 days of planned start of study therapy.
研究组 & 干预措施
pembrolizumab
Experimental
干预措施: MK-3475(pembrolizumab) (Drug)
结局指标
主要结局
Complete Pathologic Response Rate
时间窗: Up to 3 years
The primary endpoint of phase II study is to assess complete pathologic response rate. Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"
次要结局
- Disease Free Survival(Up to 3 years)
- Overall Survival(Up to 3 years)
- Pathologic Response Rate(Up to 3 years)
- Safety According to Common Terminology Criteria for Adverse Events (CTCAE) 4.03(Up to 3 years)
- Event Free Survival(Up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Phase II Study of Pre-Operative Chemotherapy in Patients With Resectable Local-Regional Carcinoma of EsophagusEsophageal DiseasesNCT00208936Emory University20
已完成
不适用
Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal CancerEsophageal CancerNCT01640860Chonnam National University Hospital36
已完成
不适用
A phase I/II trial of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal functioJPRN-UMIN000016877Clinical Study Group of Osaka University8
终止
2 期
Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic CarcinomaResectable Pancreatic CarcinomaNCT01333124National Cancer Center, Korea23
终止
3 期
Role of Esophagectomy in Complete Responders to CCRTEsophageal Squamous Cell CarcinomaNCT01740375Asan Medical Center486