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International clinical trial demonstrates improved survival with new treatment for patients with advanced gastro-oesophageal cancer

INTEGRATE late breaking oral presentation at ASCO GI 2023
INTEGRATE Oral presentation at ASCO GI 2023

The INTEGRATE IIa  (CCTG GA3) study, a phase III trial evaluated regorafenib for the treatment of patients with advanced gastro-oesophageal cancer (AGOC), has met its primary endpoint of a statistically significant improvement in overall survival of about 30%. The study evaluated the efficacy and safety of regorafenib in patients with AGOC, whose disease has progressed after a minimum of two lines of prior anti-cancer therapy for recurrent/metastatic disease. The safety and tolerability were generally consistent with the known profile of regorafenib. Detailed efficacy and safety analyses from this study were presented at the 2023 ASCO Gastrointestinal Cancers Symposium (ASCO GI).

The AGITG is leading a study currently conducted by the NHMRC CTC, a multinational phase III study called INTEGRATE IIb, which is further investigating the combination of regorafenib and nivolumab, compared to standard chemotherapy alone.

The INTEGRATE IIa study is an international, trial that randomised 251 patients from 40 recruiting sites across six countries worldwide, including North America and Asia. Patients were randomised to receive either regorafenib 160mg or placebo, with best supportive care provided to each arm.

View study abstract