A Phase II Study of PTS100 in Primary HCC Patients

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    33
  • sponsor
    Gongwin Biopharm Co., Ltd.
Updated on 24 January 2021
ct scan
platelet count
liver cancer
renal function
cancer
measurable disease
liver disease
liver transplant
international normalized ratio
prothrombin
neutrophil count
TACE
pet scan
chemoembolization

Summary

This study is being performed to evaluate the efficacy and safety of 20% and 30% PTS100 of total tumor volume as intra-tumoral injection therapy in primary Hepatocellular Carcinoma patients who are ineligible for operation or local regional therapy.

Description

BCLC stage B patients who are ineligible for operational or current locoregional therapy. Enrolled patients are randomly assigned to either of the two total doses, 20% or 30% of total tumor volume. PTS100 is administrated via intratumoral injection. The required total dose is given in separate injection days, with maximal daily dose up to 10 mL at first IP administration, and is adjusted based on each patient's tolerability along the treatment. The treatment course lasts up to completion of the total dose, and the efficacy is evaluated 28 days afterwards.

Details
Condition Adenocarcinoma, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment Para-Toluenesulfonamide
Clinical Study IdentifierNCT03447951
SponsorGongwin Biopharm Co., Ltd.
Last Modified on24 January 2021

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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