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Clinical Trials/TCTR20220202004
TCTR20220202004
Unknown
Phase 1

Clinical and pathological response of pre-operative Intratumoral and Intramuscular Poly-ICLC(Hiltonol) for cutaneous melanoma stage 2 and 3

/A0 sites12 target enrollmentFebruary 2, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
cutaneous melanoma stage 2 and 3
Sponsor
/A
Enrollment
12
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 2, 2022
End Date
February 28, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
/A

Eligibility Criteria

Inclusion Criteria

  • 1\. diagnosed with cutaneous melanoma stage 2 and 3
  • 2\. age more than 18 years old
  • 3\. expected life expectancy more than 6 months
  • 4\. ECOG 0\-1
  • 5\. inform\-consent to be part of the research
  • 6\. normal liver and kidneys functions as state in the protocol

Exclusion Criteria

  • 1\. allergy to poly\-ICLC
  • 2\. melanoma at face
  • 3\. autoimmune disease
  • 4\. history of immunologic treatment except antibody treatment and discontinue the drug more than 4 weeks
  • 5\. history of CMT, RT, or targeted therapy and discontinue less than 2 weeks
  • 6\. history of others carcinoma except BCC or SCC which can be treat locally
  • 7\. HIV infection
  • 8\. receive live attenuated vaccine and killed vaccine within 28 days before receiving 1st dose of poly\-ICLC
  • 9\. prescribed with prednisolone more than 10 mg per day except inhaled or intranasal corticosteroids
  • 10\. any health issues the might interfere with the efficacy of the drug and/or harmful to one health associated with using poly\-ICLC

Outcomes

Primary Outcomes

Not specified

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