JPRN-UMIN000023148
Recruiting
Phase 1
A phase Ib/II, multicenter study to investigate the safety, efficacy, and proof-of-concept (POC) of nivolumab monotherapy as a sequential therapy following preoperative chemoradiotherapy in patients with locally advanced resectable rectal cancer
ational Cancer CenterHospital East0 sites50 target enrollmentSeptember 1, 2016
ConditionsRectal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rectal cancer
- Sponsor
- ational Cancer CenterHospital East
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Pts who provided written consent for participation in the study
- •2\.Treatment naive pts with rectal cancer in whom the inferior margin of the tumor was at a distance of 12cm or less from the AV before CRT
- •3\.Primary rectal cancer histopathologically confirmed to be adenocarcinoma
- •4\.Stage of T3,4 N any M0 before CRT
- •5\.Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT
- •6\.Age of \>\=20 to\<80 years
- •7\.Pts with the PS 0 or 1
- •8\.CRT meeting the following conditions has been administered:
- •Radiation at a dose of 45 Gy 25 fractions to the pelvic cavity and boost radiation at a dose of 5\.4 Gy 3 fractions to the primary lesion
- •Capecitabine was started at a dose of 1650 mgm2 and administered in combination with radiation during a period equivalent to the half of 28 fractions irrespective of a dose reduction.
Exclusion Criteria
- •1\.Active multiple cancers .
- •2\.Pts with recurrent rectal cancer.
- •3\.Pts with a history of pelvic radiation.
- •4\.Pts with a history of inflammatory bowel disease.
- •5\.Pts with a history of pneumonitis or ILD.
- •6\.Pts with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
- •7\.Pts requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study.
- •8\.Pts with a history of thyroid dysfunction.
- •9\.Pts with a history or finding of cardiovascular risk falling into any of the following:
- •?left ventricular ejection rate below 50percent EF.
Outcomes
Primary Outcomes
Not specified
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