UnknownPhase 1/2

Study to Nivolumab Following Preoperative Chemoradiotherapy

Japan90 participantsStarted 2016-10

Plain-language summary

This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety, efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.

Who can participate

Age range20 Years – 80 Years

SexALL

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Exclusion criteria

✕. Patients diagnosed with active double cancer (synchronous double cancer and double cancer with disease-free period within five years from enrollment).
✕. Patients with a history of pelvic irradiation prior to this rectal cancer treatment.
✕. Patients who have not given consent through the informed consent form.
✕. Patients deemed by the investigator to be ineligible for the trial.

What they're measuring

Pathological complete response

Timeframe: 1 year

Trial details

NCT IDNCT02948348

SponsorTakayuki Yoshino

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

Contact for this trial

Hideaki Bando, Dr

+81-52-762-6111 voltage_core@east.ncc.go.jp

View on ClinicalTrials.gov More Cancer of Rectum trials