Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients
NCT Number: NCT06529718
Acronym: SEVILLA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Biliary Tract Cancer
Interventions: DRUG: Ivonescimab|DRUG: FOLFOX regimen
Sponsor: UNICANCER
Collaborators: Cancer Research UK & UCL Cancer Trials Centre|Belgian Group of Digestive Oncology|Summit Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-30
Completion Date: 2029-01-30
Locations: Cliniques universitaires Saint-Luc, Brussels, Belgium|Institute Mutualiste Montsouris, Paris, France|Centre Eugène Marquis, Rennes, France|University College London, London, United Kingdom

Summary:
The object of this trial is to test whether ivonescimab is superior to standard chemotherapy (FOLFOX regimen) for the treatment of patients with advanced biliary tract cancer after failure of a first line of chemotherapy. It is only open to patients who participated in the SAFIR-ABC10 trial (NCT05615818) but did not receive experimental treatment.

Eligible patients will be randomised (2:1) to receive either ivonescimab or FOLFOX. Treatment will be continued until disease progression, or a maximum of 34 cycles of ivonescimab (experimental arm), whichever occurs first.

Primary Outcome Measures: Progression-free survival (PFS), The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse., From randomisation to disease progression or death, up to 4 years
Secondary Outcome Measures: Overall Survival (OS), The overall survival is the length of time from randomization that patients enrolled in the study are still alive., From randomisation to death, up to 4 years|Objective response rate, The proportion of patients achieving complete response (CR) or partial response (PR) (according to RECIST v1.1). Objective response rate will be presented as the best response achieved compared to the disease assessment performed at randomisation., From randomisation, up to 4 years|Disease control rate, The proportion of randomised patients achieving CR, PR, stable disease (SD) as assessed by the investigator according to RECIST v1.1, From randomisation, up to 4 years|Duration of response, The time from first documented response (compared to baseline measurement taken at randomisation) until the date of disease progression, as assessed by the investigator according to RECIST v1.1, or death from any cause whichever occurs first., From response to disease progression or death, up to 5 years
Other Outcome Measures: Quality of life questionnaire - Core 30 (QLQ-C30), Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level., From baseline, every 2 cycles (every 4-6 weeks) until end of treatment, an average of 1 year|Quality of life Questionnaire - Biliary tract cancer module (QLQ-BIL21), This EORTC cholangiocarcinoma and gallbladder cancer specific questionnaire is intended to supplement the QLQ-C30.

The QLQ-BIL21 contains 21 items to assess symptoms. 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, and 18 items grouped into 5 scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms., From baseline, every 2 cycles (every 4-6 weeks) until end of treatment, an average of 1 year|Incidence of Adverse Events, Safety and tolerability of the treatment will be evaluated using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5). NCI-CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders., From randomisation, up to 4 years