JPRN-jRCTc030190248已完成1 期
A clinical study on the safety of preoperative comprehensive immune-cell therapy against progressive rectal cancer.
Sakamoto Kazuhiro0 个研究点目标入组 6 人开始时间: 2020年3月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
This clinical study was approved on January 24, 2019, and case enrollment began in March of the same year. Protocol treatment (mFOLFOX 6 x 6 courses, immune cell therapy x 6 injections) was completed for all 6 registered cases. Safety was evaluated as the primary endpoint, and side effects of Grades 1 to 3 due to mFOLFOX6 occurred, but all recovered. There were no side effects for immune cell administration. The present study showed that preoperative comprehensive immunotherapy (mFOLFOX6 + immune cells) for
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •(1)Patient musy be diagnosed as adenocarcinoma pathologically including papillary adenocarcinoma, tubular adenocarcinoma, anaplastic adenocarcinoma, colloid carcinoma, signet ring cell adenocarcinoma and medullar cancer, by endoscopic biopsy from primary lesion in rectum.
- •(2)Tumor must exist in either Ra or Rb mainly.
- •(3)Patient must be included one criteria below:
- •a) diagnosed as above cT3 by either abdominal or pelvis contrast-enhanced CT or contrast-enhanced MRI.
- •b) diagnosed as above cN1, that is, lymph mode metastasis has detected by pelvis contrast-enhanced CT with slice thickness of below 5mm. However, patient of cT4b must be excluded if infiltration is suspected to either trigon of bladder, urethra or sacred bone.
- •(4)Patient must be diagnosed bas cM0, that is, distant metastases have not been detected by either chest CT, abdominal or pelvis contrast-enhanced CT or contrast enhanced MRI of slice thickness of below 5mm
- •(5)Patient must be between 20 and 80 years old at registration.
- •(6)Patient must be 0, 1 of ECOG PS score.
- •(7)Patient must have no previous chemotherapy, no proctectomy, but local excision, no pelvis lymphadenectomy for any cancers.
- •(8)Patient must not have multicentric cancer according to comprehensive diagnosis using colonoscopy and imaging, that is barium enema examination or abdomen/pelvis contrast-enhanced CT, or CT colonography.
- •(9)Test results within 14 days before the registration satisfies all the requirements
- •(10)Either abdominal operation or laparoscopic surgery must be planned.
- •(11)Patient must have given written consent to the study
排除标准
- •(1)Patient must not have active multiple cancer. Active multiple cancer means concurrent multiple cancer or multi centric cancer and non-concurrent multiple or multi centric cancer which has intervals within 5 years without disease.
- •However carsinoma in situ and intramucosal carcinoma are not included in active cancer as they are curable by local treatment.
- •(2)Patient must not have infectious disease which requires systemic therapy.
- •(3)Patient must not be HIV positive, nor HTLV-1 positive.
- •(4)Patient must not be microsatellite instability (MSI) positive.
- •(5)Patient must not have fever over 38 degrees centigrade at registration.
- •(6)Pregnant woman, woman possible to be pregnant, woman within 28 days after delivery and nursing woman must be excluded.
- •(7)Patient that has mental disorders or neurologic manifestation must be excluded.
- •(8)Patient that continuous whole body oral or intravenous administration of steroid or other immunosuppressive drug
- •(9)Patient that has one or mutiple of diseases among interstitial pneumonia, pulmonary fibrosis, intense pneumonectasia diagnosed by chest CT must be excluded.
- •(10)Patient that has active autoimmune disease must be excluded.
- •(11)Patient that has diabetes either during continuous insulin treatment or under poor control must be excluded.
- •(12)Patient that has insecurity angina pectoris, that is, angina pectoris which occurs or aggravates within 3 weeks, and patient that has previous heart infarction within 6 months.
- •(13)Patient that doctor(s), either principal researcher or member of the project has judged inappropriate to join this study must be excluded.
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