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

Section NCT
Category Gastrointestinal tumors
Subcategory Hepatobiliary tumors
Trial Type Adjuvant Therapy
Description for experts 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.
Description for laymen 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)
JSON Data { "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 }
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Short name 900-000002444