Preoperative immunotherapy with atezolizumab (Tecentriq®) and tiragolumab in patients with colorectal liver metastases (CRLM) (the PURPLE trial)

Conditions

Colorectal liver metastases (CRLM)

Brief summary

Percentage of resected patients with complete or major pathological regression

Detailed description

Percentage of patients who underwent surgery after preoperative IO therapy, Incidence, relatedness and severity of adverse events occurring during preoperative short time immunotherapy within 90 days of surgery (Severity for all events will be graded according to NCI CTCAE v5.0), Assessment of postoperative complication rates according to the Clavien-Dindo Classification, Mortality within 90 days of surgery, Estimation of curative (R0) resection rate, Assessment of PET response (PET-CT or PET-MRI) after short term immunotherapy, Patients, who do not undergo surgery: Reasons for not having surgery, Percentage of resected patients with complete or major pathological regression as evaluated by independent central review

Related papers

No related papers found yet.

Interventions

DRUGTecentriq 840 mg concentrate for solution for infusion

DRUGTiragolumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of resected patients with complete or major pathological regression	—

Secondary

Measure	Time frame
Percentage of patients who underwent surgery after preoperative IO therapy, Incidence, relatedness and severity of adverse events occurring during preoperative short time immunotherapy within 90 days of surgery (Severity for all events will be graded according to NCI CTCAE v5.0), Assessment of postoperative complication rates according to the Clavien-Dindo Classification, Mortality within 90 days of surgery, Estimation of curative (R0) resection rate, Assessment of PET response (PET-CT or PET-MRI) after short term immunotherapy, Patients, who do not undergo surgery: Reasons for not having surgery, Percentage of resected patients with complete or major pathological regression as evaluated by independent central review	—

Measure

Time frame

Percentage of patients who underwent surgery after preoperative IO therapy, Incidence, relatedness and severity of adverse events occurring during preoperative short time immunotherapy within 90 days of surgery (Severity for all events will be graded according to NCI CTCAE v5.0), Assessment of postoperative complication rates according to the Clavien-Dindo Classification, Mortality within 90 days of surgery, Estimation of curative (R0) resection rate, Assessment of PET response (PET-CT or PET-MRI) after short term immunotherapy, Patients, who do not undergo surgery: Reasons for not having surgery, Percentage of resected patients with complete or major pathological regression as evaluated by independent central review

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Countries

Germany

Outcome results

None listed