Squamous cell carcinoma of the anal canal
Conditions
Brief summary
The clinical complete response rate of patients with localized squamous cell carcinoma of the anal canal, defined as the percentage of patients who have achieved complete response, disappearance of all lesions according to RECIST 1.1 and Mandard criteria and no presence of residual disease assessed by biopsy at the end of consolidation phase. For more details, refer to the section 1.14 of the protocol.
Detailed description
Secondary efficacy endpoints: Locoregional failure rate (LFR), Secondary efficacy endpoints: Disease-free survival (DFS), Secondary efficacy endpoints: Colostomy-free survival (CFS), Secondary efficacy endpoints: Overall survival (OS), Secondary safety endpoints: Adverse events (AE), Secondary safety endpoints: Treatment-related AEs (TRAEs), Secondary safety endpoints: Patient reported outcomes through the EORTC QLQ-C30 questionnaire
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGTiragolumab
Sponsors
Grupo Espanol Multidisciplinar En Cancer Digestivo
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical complete response rate of patients with localized squamous cell carcinoma of the anal canal, defined as the percentage of patients who have achieved complete response, disappearance of all lesions according to RECIST 1.1 and Mandard criteria and no presence of residual disease assessed by biopsy at the end of consolidation phase. For more details, refer to the section 1.14 of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints: Locoregional failure rate (LFR), Secondary efficacy endpoints: Disease-free survival (DFS), Secondary efficacy endpoints: Colostomy-free survival (CFS), Secondary efficacy endpoints: Overall survival (OS), Secondary safety endpoints: Adverse events (AE), Secondary safety endpoints: Treatment-related AEs (TRAEs), Secondary safety endpoints: Patient reported outcomes through the EORTC QLQ-C30 questionnaire | — |
Countries
Spain
Outcome results
None listed