cancer
Conditions
Brief summary
Number of patients with clinical complete response evaluated day 93 (+/- 7 days) after one or two cycles of immunotherapy. Complete clinical response will be defined as no visible or palpable tumor examined by rectal exploration (if low tumors), endoscopy and MR-scan. Patients with definite but less than complete regression BUT with a representative biopsy without viable tumor cells will also be classified as cCR in this trial.
Detailed description
Number of patients with complete biological response after 1 or 2 cycles of immunotherapy., Number of patients without any sign of recurrence after 12 months., Response rate according to mrTRG (24)., Adverse events., Correlation between bio-markers (ctDNA and CEA) and outcome., Quality of life (EORCT QLQ-C30 and EORCT QLQ-CR29).
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with clinical complete response evaluated day 93 (+/- 7 days) after one or two cycles of immunotherapy. Complete clinical response will be defined as no visible or palpable tumor examined by rectal exploration (if low tumors), endoscopy and MR-scan. Patients with definite but less than complete regression BUT with a representative biopsy without viable tumor cells will also be classified as cCR in this trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with complete biological response after 1 or 2 cycles of immunotherapy., Number of patients without any sign of recurrence after 12 months., Response rate according to mrTRG (24)., Adverse events., Correlation between bio-markers (ctDNA and CEA) and outcome., Quality of life (EORCT QLQ-C30 and EORCT QLQ-CR29). | — |
Countries
Denmark
Outcome results
None listed