D7025C00001 Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

{ "short_title": "D7025C00001 Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)", "data_mode": "900", "data_mode_number": "000002444", "official_title": "A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": "adjuvant", "therapielinie_value": "not_applicable", "ctgov_number": "NCT06109779", "eudract_number": null, "general_contact_email": "oncostudy@ukdd.de", "general_contact_phone": "+49 351-4587666", "hauptpruefer_dd_name": "Prof. Dr. med. Gunnar Folprecht", "description_laie_de": "Eine randomisierte, doppelblinde, placebokontrollierte, multizentrische, globale Phase-III-Studie zu Rilvegostomig in Kombination mit Chemotherapie als adjuvante Behandlung nach Resektion von Gallenwegskrebs mit kurativer Absicht (ARTEMIDE-Biliary01)", "description_laie_en": "A Phase III, Randomized, Double-Blind, Placebo-Controlled, \r\nMulticenter, Global Study of Rilvegostomig in Combination With \r\nChemotherapy as Adjuvant Treatment After Resection of Biliary \r\nTract Cancer With Curative Intent (ARTEMIDE-Biliary01)", "description_expert_de": "Eine randomisierte, doppelblinde, placebokontrollierte, multizentrische, globale Phase-III-Studie zu Rilvegostomig in Kombination mit Chemotherapie als adjuvante Behandlung nach Resektion von Gallenwegskrebs mit kurativer Absicht (ARTEMIDE-Biliary01)", "description_expert_en": "A global study to assess the efficacy and tolerability of rilvegostomig compared toplacebo in combination with investigator's choice of chemotherapy in participants withBTC after surgical resection with curative intent.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 2, "sub_cat_id": 7 }