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Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC - Healing Genes
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Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC

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Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC

Multicenter Randomized Controlled Trial of Adenovirus-mediated Adjuvant Gene Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma


Phase 3

DESCRIPTION:

Researchers in China are seeking patients with advanced hepatocellular carcinoma, who are expecting liver transplants, to trial an investigatory drug that aims to improve the outcome of liver transplantation. The gene therapy, ADV-Tk, transfers a suicide gene via viral vector to the tumor and stimulates the body’s immune system to find and kill cancer cells. It will be provided in concert with a liver transplant.

A portion of participants will receive a liver transplant but only placebo drug, but neither the researchers nor the patients will know which they are receiving. Follow up will continue for ~2 years.


PATIENT MUST:

  • Be 18 to 65 years of age
  • Have a clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation
  • Not have metastasis in extrahepatic main vascular and extrahepatic lymph node detected during the operation and no metastasis of other organs

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Liver transplant is scheduled and the investigatory drug will be injected into the peritoneum tissues around the liver.
  3. At 60 and 90 days, second and third doses are injected to the celiac artery and the superior mesenteric artery via femoral-artery puncture.
  4. Follow up continues for 2 years.

LOCATIONS AND CONTACTS:

Contact the study’s primary investigator to learn the study’s multiple research locations in China.

Contact: Danhui Weng, Dr.  |  027-83663351  |  [email protected]

 

SPONSOR INFORMATION:

Huazhong University of Science and Technology

Beijing YouAn Hospital

 

Or go online:

https://clinicaltrials.gov/show/NCT03313596

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