Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, has started a Phase 1 clinical study of a personalized tumor neoantigen mRNA vaccine for patients with six types of digestive system cancer who are at high risk of recurrence after surgery.

Launched in early August, the study plans to enroll 18 patients with pancreatic, liver, biliary tract, esophageal, gastric or colorectal cancer. Two patients with pancreatic cancer have enrolled, and recruitment is continuing. Patients must enroll before surgery so fresh tumor tissue can be collected and used to customize the vaccine.

In an earlier phase of the research, which began in 2023, the hospital treated 43 patients with pancreatic, liver, or biliary tract cancer. A pancreatic cancer patient surnamed Liu traveled from Northeast China to Hangzhou for treatment. He underwent a pancreaticoduodenectomy led by hospital president Cai Xiujun, followed by standard chemotherapy combined with a vaccine customized using his tumor sample. His latest examinations showed no recurrence, the hospital said.

The vaccine is therapeutic and intended to lower the risk of recurrence after surgery rather than prevent cancer in healthy people.

Separately, Moderna and Merck said their individualized mRNA cancer therapy combined with Keytruda produced positive Phase 3 results in a trial involving 1,137 patients with completely resected high-risk melanoma. The trial met its primary endpoint and a key secondary endpoint. The melanoma trial is separate from the Zhejiang program.