Shanghai researchers have completed the world's first Phase I clinical trial of CAR-T therapy with a target on glypican-3, a type of carcinoembryonic antigen, to treat advanced hepatocellular carcinoma (HCC).
CAR-T, which stands for chimeric antigen receptor, involves removing T-cells from a patients' blood and reprogramming them to attack infected cells after they are reintroduced to the body.
A paper about the study, led by Zhai Bo, director of the department of oncology intervention at Shanghai Renji Hospital, and Li Zonghai, founder of CARsgen Therapeutics, a Shanghai-based biomedical enterprise, was published on the website of the United States-based journal Clinical Cancer Research on May 5, the hospital said on Wednesday.
Thirteen patients received the therapy as of July last year. Pyrexia, decreased lymphocyte count and cytokine release syndrome (CRS) were observed in 13, 12 and nine patients respectively.
The team said that the patients responded well to the treatment, which was safe and controllable, and showed little serious side effects.
The overall survival rates at three years, one year and six months were 10.5 percent, 42 percent and 50.3 percent respectively.
Zhai said that the clinical trial demonstrated the initial safety profile of this CAR-T therapy.
"Moreover, patients with advanced HCC who underwent this therapy also showed early signs of antitumor activity," he said.
A patient who has been involved in the study since July 2015 has been healthy for nearly five years, the team said. Regular examinations did not find new lesions and the patient's tumor indicators in blood have remained normal.
Liver cancer is one of the major diseases that seriously threatens the life and health of Chinese people. Official data shows that there are more than 460,000 new liver cancer cases every year in the country, with the median survival period of those in advanced stages being one year.
Zhai said most liver cancer patients are diagnosed at the middle or terminal stages and hence may not be able to undergo surgery.
"Although there are some therapies available to such patients, doctors are looking for more efficient and low-toxic systemic solutions to treat such cases with high recurrence and metastasis rates," he said.