Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Flow-analysis of lymphocytic subpopulations in blood
研究概览
简要总结
The aim of this randomized double-blinded placebo-controlled phase 2 study is to determine efficacy of preoperative treatment with interferon-alfa2a in patients with pMMR colon cancer on perioperative immune suppression and infiltration of lymphocytes in the primary tumor.
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
- Double (Participant, Investigator)
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
- •Patients above 18 years of age.
- •Patients diagnosed with pMMR colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy.
- •ASA class I-III (Classification of the American Society of Anesthesiology)
排除标准
- •Patients with childbearing potential without a negative pregnancy test before initiating study drug and / or non-acceptance to the use of contraceptive methods *
- •ECOG score function> / = 3
- •Current liver or renal disease.
- •Severe heart disease
- •Previous depression diagnosed by a psychiatrist or in treatment with antidepressant
- •Autoimmune disease.
- •Uncontrolled thyroid disease.
- •Patients who are or have recently (within 6 months) received treatment with immunosuppressive agents other than corticosteroid treatment.
- •Epilepsy and / or other serious CNS disorders.
- •Patients that have undergone major surgery within one month before planned colon resection.
- •Known hypersensitivity to recombinant interferon or auxiliary products of Pegasys®.
- •Spiral, pill, implant, transdermal patch, vaginal ring or depot injection. Sterile / infertile subjects are exempt from the use of contraception. To be considered sterile or infertile must generally be surgical sterilization (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months prior to study enrolment.
研究组 & 干预措施
Intervention arm
Two 45 mikrogram doses of interferon-alfa2a (Pegasys). Both will be applied subcutanously. First dose is at least one week before surgery. Second dose on the day of surgery before the procedure.
干预措施: Pegasys (Drug)
Placebo
Two 1 ml doses of saline liquid. Both will be applied subcutanously. First dose is at least one week before surgery. Second dose on the day of surgery before the procedure.
干预措施: Saline (Drug)
结局指标
主要结局
Flow-analysis of lymphocytic subpopulations in blood
时间窗: Change between day of surgery (day 7-14 after first treatment) and postoperative day 1.
Change in CD3, CD4, and CD8 between intervention and placebo groups
T-cell infiltration in tumor
时间窗: Day of surgery (day 7-14 after first treatment)
Difference in CD3, CD4 and CD8 T-cell infiltration between intervention and placebo groups
次要结局
- Quality of recovery (QoR-15)(Third postoperative day and postoperative day 12-16)
- Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor(Day of first treatment (Day 0) and day of surgery (day 7-14 after first treatment))
- cfDNA analysis in blood(Day of first treatment (Day 0), day of surgery (day 7-14 after first treatment), postoperative day 2, postoperative day 12-16, and postoperative day 28-32.)
- CRP and neutrophil/lymphocyte ratio(Day of surgery (day 7-14 after first treatment))
- Immunological and inflammatory cytokines and interleukins(Day of surgery (day 7-14 after first treatment) and postoperative day 1.)
- Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis of tumor biopsy and resected specimen(Day of standard endoscopic biopsy (Day -7-14 before treatment) and day of surgery (day 7-14 after first treatment))