Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer

Not yet recruitingOBSERVATIONAL
Enrollment

38

Participants

Timeline

Start Date

January 1, 2023

Primary Completion Date

June 1, 2023

Study Completion Date

June 1, 2026

Conditions
Locally Advanced Rectal CarcinomaMSI-High
Interventions
DRUG

Envafolimab

Patients will receive single drug therapy of Envafolimab (300mg) once every two weeks. Patients who do not have tumor regression after 3 months of treatment should be judged by the investigator whether to adopt standard chemoradiotherapy plus surgery. Patients with tumor regression should continue to receive Envafolimab therapy until 6 months. For patients who do not reach complete clinical response (cCR) after 6 months of treatment, the investigator shall determine whether to perform standard chemoradiotherapy or radical surgery. For patients who reach cCR, they could receive the observation waiting or local resection which depend on the investigator. Patients should be followed up until reaching cCR or 3 years after surgery.

All Listed Sponsors
lead

Fudan University

OTHER

NCT05645094 - Neoadjuvant Envafolimab in Resectable and Locally Advanced MSI-H/dMMR Rectal Cancer | Biotech Hunter | Biotech Hunter