Condition: Squamous Cell Carcinoma of the Anal Canal · Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo
The peculiarity of anal cancers, with well-established radical chemoradiotherapy that allows tumor-neoantigen formation with platinum-based chemotherapy and radiotherapy with radio-sensitizing chemotherapy could create the perfect environment for immunotherapy in this setting, not only to increase the probability of pathological complete response (CCR) but also creating neoantigen exposure and immune-prevention to reduce the relapse after surgery. TIRANUS trial is a Phase II, single-arm, open-label, non randomized, non controlled recruiting treatment-naive localized squamous cell carcinoma of the anal canal and are candidates for radical chemoradiotherapy. The trial hypothesizes that the addition of immunotherapy (atezolizumab and tiragolumab) to standard chemoradiotherapy in localized squamous cell carcinoma of the anal canal may improve the CCR at the end of consolidation phase. The study will assess, as the primary endpoint, the CCR, defined as the percentage of patients who have achieved complete response (CR), disappearance of all target lesions and no presence of residual disease assessed by biopsy at the end of consolidation phase. Secondary objectives include survival, safety of the combination, patient reported quality of life, and a substudy of molecular biomarkers determined in tumor biopsy and blood samples. The main question\[s\] it aims to answer are: 1. To determine the efficacy of atezolizumab plus tiragolumab concomitantly with chemoradiotherapy in patient…
This description comes directly from the study's public registry record.
A responsible person Designated by the Sponsor · +34 93 434 44 12 · investigacion@mfar.net
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| Hospital Universitario Son Espases | Palma de Mallorca, Balearic Islands, Spain | Recruiting |
| Institut Català d'Oncologia (ICO) Hospitalet | L'Hospitalet de Llobregat, Barcelona, Spain | Recruiting |
| Hospital Arnau de Vilanova | Lleida, Barcelona, Spain | Recruiting |
| Hospital Sant Joan Despí | Martorell, Barcelona, Spain | Recruiting |
| Consorcio Corporación Sanitaria Parc Taulí | Sabadell, Barcelona, Spain | Recruiting |
| Hospital General Universitario de Toledo | Toledo, Castille-La Mancha, Spain | Recruiting |
| HU Puerta de Hierro Majadahonda | Majadahonda, Madrid, Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona, Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona, Spain | Recruiting |
| Hospital General de Ciudad Real | Ciudad Real, Spain | Recruiting |
| Complejo Asistencial Universitario de León | León, Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid, Spain | Recruiting |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05661188