A Phase II Study of Induction Tucatinib and Trastuzumab With Total Neoadjuvant Therapy for Locally Advanced HER2-amplified Rectal Adenocarcinoma

Memorial Sloan Kettering Cancer Center13 个研究点分布在 1 个国家目标入组 37 人2022年12月30日

适应症Adenocarcinoma of the Rectum Locally Advanced Rectal Adenocarcinoma Rectal Adenocarcinoma HER2 Positive Rectal Adenocarcinoma Rectal Cancer

干预措施Trastuzumab Tucatinib

概览

阶段: 2 期
干预措施: Trastuzumab
疾病 / 适应症: Adenocarcinoma of the Rectum
发起方: Memorial Sloan Kettering Cancer Center
入组人数: 37
试验地点: 13
主要终点: Clinical complete response of study participants
状态: 招募中
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.

注册库

clinicaltrials.gov

开始日期

2022年12月30日

结束日期

2030年7月31日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Memorial Sloan Kettering Cancer Center

责任方

Sponsor

入排标准

入选标准

•Willing and able to provide written informed consent for the trial.
•Be ≥18 years of age on the date of signing informed consent.
•ECOG performance status of 0 or
•Histologically confirmed rectal adenocarcinoma.
•Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3/cT4 N0 or cT(any) cN1/2,
•No evidence of distant metastases
•Radiologically measurable or clinically evaluable disease per Protocol Section 13.
•Have confirmed HER2-positive rectal adenocarcinoma, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, meeting at least one of the following criteria:
•HER2+ overexpression (3+ immunohistochemistry \[IHC\]) by an FDA-approved HER2 IHC test following the package insert's interpretational manual for gastric cancer
•HER2 2+ IHC is eligible if the tumor is amplified by an FDA-approved HER2 in situ hybridization assay (FISH or chromogenic in situ hybridization \[CISH\]) following the package insert's interpretational manual for gastric cancer

排除标准

•Recurrent rectal cancer.
•Prior pelvic radiation therapy, chemotherapy, or surgery for rectal cancer.
•Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).
•Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.
•Active infection requiring systemic therapy.
•Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.
•Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
•Known active Hepatitis B (e.g., HbsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
•Any known chronic (non-transient) liver disease in the patient's past medical history such as (but not limited to) cirrhosis, NASH (non-alcoholic steatohepatitis) or NAFLD.
•Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.

研究组 & 干预措施

Participant with Rectal Adenocarcinoma

Participants will have HER2-positive locally advanced rectal adenocarcinoma.

干预措施: Trastuzumab

Participant with Rectal Adenocarcinoma

Participants will have HER2-positive locally advanced rectal adenocarcinoma.

干预措施: Tucatinib

结局指标

主要结局

Clinical complete response of study participants

时间窗: 21 +/- 4 weeks

The primary objective of this trial is to determine the clinical complete response rate after the completion of initial neoadjuvant tucatinib and trastuzumab followed by standard of care induction chemotherapy (assessed around week 21 ± 4 weeks) in subjects with HER2-positive, RAS wild-type locally advanced rectal adenocarcinoma