A randomized, open-label Phase II/III efficacy and safety study of atezolizumab in combination with FLOT versus FLOT alone in patients with gastric cancer and adenocarcinoma of the oesophagogastric junction and high immune responsiveness
DANTE / FLOT8
Coordinating investigator
The prognosis for gastric cancer remains highly unsatisfactory, with a 5-year survival rate of under 40%. To improve the prognosis of patients with operable gastric cancer or carcinoma of the gastroesophageal junction, the DANTE trial investigates FLOT chemotherapy (currently the standard treatment) in combination with the checkpoint inhibitor atezolizumab.
Around 550 patients with stomach cancer and cancer at the junction between the esophagus and stomach will be included in the DANTE trial. They are randomly divided into two groups: The first group of patients will receive four cycles of standard FLOT therapy before and after surgery to remove the tumor. In addition to this treatment, the second group will receive the antibody described above before and after the operation, as well as after completion of chemotherapy. All trial participants will be monitored for a maximum period of 10 years after the therapy. The researchers will then analyze whether the prognosis of those affected has been improved by the extended combination therapy with the five components and whether atezolizumab should be added to the standard therapy.
By 2022, 295 patients had already taken part in the trial. Atezolizumab treatment had a positive effect, particularly in patients whose gastric cancer had a particularly high level of PD-L1 protein on the cell surface. This confirms the assumption that the cancer can no longer hide well from the immune system thanks to atezolizumab and that the patient's own immune system supports the chemotherapy in eliminating the tumor.
The DANTE trial therefore gives hope in gastric cancer treatment. The innovative combination of established standards with new therapeutic approaches increases the chance of more effective future cancer treatments.
This trial is funded by the State Secretariat for Education, Research and Innovation (SERI) and the Swiss Group for Clinical Cancer Research (SAKK) and supported by a grant from Roche Pharma Schweiz AG and SSKK (Swiss Foundation for Clinical Cancer Research).
We thank for their support.
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