Trial to assess the efficacy and safety of atezolizumab in combination with FLOT in patients with gastric cancer or adenocarcinoma of the gastroesophageal junction

DANTE / FLOT8

Coordinating investigator

Dr. med.
Alexander
Siebenhüner
Kantonsspital Schaffhausen
+ 41 52 634 33 80

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 plans to investigate FLOT chemotherapy (currently the standard treatment) in combination with the checkpoint inhibitor atezolizumab.

On enrolment in the trial, the patients will be randomized on a 1:1 basis: Patients in Arm A will receive atezolizumab in combination with FLOT for four two-week cycles. Following surgery, the patients will then be treated again with the combination therapy for four two-week cycles, followed by maintenance treatment with 8 cycles of atezolizumab alone. Patients in Arm B will receive pre- and postoperative treatment with FLOT alone for four two-week cycles.

The aim of the trial is to investigate the efficacy, safety and toxicity of the treatment with FLOT plus atezolizumab versus chemotherapy with FLOT alone. 295 patients are to be enrolled in total.

The combination therapy of FLOT and atezolizumab to be investigated in the DANTE trial may prove to be a valuable therapeutic option for patients with locally advanced, operable gastric cancer or carcinoma of the gastroesophageal junction. The combination therapy might lead to a better prognosis for these patients in future.

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