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Clinical Trials/JPRN-jRCTc031190098
JPRN-jRCTc031190098
Completed
Phase 2

A clinical trial on the efficacy of combination therapy with immune-cell therapy(electroloading dendritic cell) and immune check point inhibitor for malignant tumor - Combination therapy with immune-cell therapy and immune check point inhibitor

Takimoto Rishu0 sites40 target enrollmentSeptember 19, 2019
Conditionsmalignant tumor

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
malignant tumor
Sponsor
Takimoto Rishu
Enrollment
40
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The study is terminated due to lack of hope for case enrollment.

Registry
who.int
Start Date
September 19, 2019
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Takimoto Rishu

Eligibility Criteria

Inclusion Criteria

  • A patient MUST:
  • 1\) Be diagnosed with relapsed or advanced malignant tumor.
  • 2\) Have a measurable lesion of tumor.
  • 3\) Have an Eastern Cooperative Oncology Group performance\-status score of 0 or 1\.
  • 4\) Be administered immune check point inhibitor and immune\-cell therapy within 4 weeks at the clinic.
  • 5\) Have an adequate function of liver, kidney, and bone marrow when the eligibility is confirmed.
  • 6\) Provide agreement of the attending doctor to participate in this study.
  • 7\) Have a backup hospital in the case of emergency.
  • 8\) Provide written consent to participate in this study.

Exclusion Criteria

  • A patient MUST NOT:
  • 1\) Have a positive result of HIV antibody.
  • 2\) Have a T cell\-, NK cell\-derived malingnant lymphoma/leukemia (in the case of activated immune\-cell therapy).
  • 3\) Be post allogenic bone marrow transplantation.
  • 4\) Have a history of a serious adverse event due to immune check point inhibitor.
  • 5\) Be a female who is pregnant, lactating, or with a possibility of pregnancy.
  • 6\) A patient who is judged as inadequate for enrolment by doctors is excluded

Outcomes

Primary Outcomes

Not specified

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