A Chinese-led clinical trial has delivered the world’s first randomized evidence that CAR-T cell therapy can extend survival in solid tumor patients, marking what experts call a “milestone” in cancer treatment.
Results published in The Lancet and presented at the 2025 ASCO Annual Meeting in Chicago show that patients with advanced gastric or gastroesophageal junction (GEJ) cancer who received CAR-T therapy lived a median of 7.9 months, compared to 5.5 months with standard care—a survival gain of about 40%. Progression-free survival also improved, from 1.8 months in the control group to 3.3 months with CAR-T cell therapy.
The trial, led by Peking University Cancer Hospital and several Chinese institutions in collaboration with Shanghai-based CARsgen Therapeutics, involved more than 100 patients whose disease had failed at least two prior treatments. Researchers said the results suggest CAR-T “may represent a paradigm shift” for patients with few options.
Dr. Carl June, a pioneer of CAR-T therapy at the University of Pennsylvania, called the findings “exciting” and the first positive randomized trial of CAR-T in solid tumors. ASCO expert Dr. Jason Luke of the University of Pittsburgh added: “This is a very important milestone study that should unite the cancer research community.”
Solid tumors—including breast, lung, and pancreatic cancers—account for about 90% of all cancers. While CAR-T cell therapy has transformed blood cancer treatment, its application to solid tumors has remained elusive until now.
At ASCO, a second study from the University of Pennsylvania also reported early signs of benefit in glioblastoma, showing CAR-T could shrink brain tumors and extend survival.
Dr. John Haanen of the Netherlands Cancer Institute described CAR-T cell therpay as “a new generation of therapies that oncologists have never seen before.” Cancer Research UK’s Dr. Catherine Elliott called the gastric cancer results “encouraging,” though she emphasized the need for larger trials before broad adoption.
