Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

August 15, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Rectal Cancer
Interventions
RADIATION

split-course hypofraction radiotherapy

After reaching a cumulative radiotherapy dose of 25Gy in the entire pelvic cavity (PTV1), the treatment field was subsequently narrowed to solely focus on the primary tumor (PTV2), with a total dose of 35Gy administered. All patients will undergo fractionated radiotherapy, following a regimen of 7Gy per fraction, delivered every 3 weeks for five cycles.

DRUG

CAPOX

Drug: Oxaliplatin,130mg/m2,ivgtt,d1,for 6 cycles. Drug: Capecitabine,1000mg/m2,po,bid,d1-14, for 6 cycles.

DRUG

Envafolimab

Envafolimab is administered by subcutaneous injection. The recommended dose is 300 mg per 3 weeks (Q3W) for 6 cycles.

PROCEDURE

Local excision

Local full-thickness resection is employed for patients with clinical complete response (cCR) or near-clinical complete response (ncCR) following TNT.

Trial Locations (1)

350001

Pan Chi, Fuzhou

All Listed Sponsors
lead

池畔

OTHER

NCT05969847 - Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer | Biotech Hunter | Biotech Hunter