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临床试验/JPRN-jRCT2073220054
JPRN-jRCT2073220054招募中1 期

Phase I clinical trial of GAIA-102 for refractory/relapse neuroblastomas or malignant pediatric solid tumors with lung metastases.

Kawakubo Naonori0 个研究点目标入组 36 人开始时间: 2022年9月23日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
36

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 1age old 至 <= 24age old(—)
性别
All

入选标准

  • 1. Patients who have been confirmed to have the following malignant tumor by histological examination
  • - single cohort : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) .
  • - combination cohort : neuroblastoma.
  • 2. Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.
  • 3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.
  • 4. Patients aged from 1years to 24 years at the time of obtaining consent.
  • 5. Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent.

排除标准

  • 1.Patients with brain metastases.
  • 2.Patients diagnosed with cancerous meningitis
  • 3.Patients who received allogeneic hematopoietic stem cell transplant.
  • 4.Patients with active autoimmune disease.

研究者

发起方
Kawakubo Naonori

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