A pilot study targeting lower rectal and anal adenocarcinoma for preliminary efficacy and safety of OBP-301 in combination with chemoradiation therapy

Not provided0 sites10 target enrollmentStarted: TBD

Conditions

Trial Snapshot

No summary available.

•Patients whose tumor is located primarily either in the lower rectum (Rb) or the anal canal (P).
•Histologically confirmed adenocarcinoma by endoscopic biopsy of lower rectal or anal canal.
•Eligible for curative surgery and neoadjuvant chemoradiation therapy.
•Patients who request capecitabine treatment as a part of neoadjuvant therapy.
•Patients whose tumor size can be covered 3-dimensionally by a total of 1 mL of OBP-301 injection..
•Other protocol-defined Inclusion criteria may apply.

•Patients with other active tumors that require treatment with higher priority than that for lower rectal or anal adenocarcinoma.
•Patients with active infection at baseline that require systemic therapy.
•Patients with prior rectal resection (excluding endoscopic resection) or treatment history, including those for other tumors, of radiotherapy to pelvis and fluoropyrimidine-based therapy.
•Patients with uncontrollable concurrent disease of important organs that principle investigator considers inappropriate for study participation.
•Other protocol-defined Exclusion criteria may apply.

Sponsor

Not provided