NCT06872606View on ClinicalTrials.gov

Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2028

Conditions
Rectal Adenocarcinoma
Interventions
DRUG

Pucotenlimab

Pucotenlimab (200 mg IV, q3w)

DRUG

Bevacizumab

Bevacizumab (7.5 mg/kg IV, q3w)

DRUG

Oxaliplatin

Oxaliplatin (130 mg/m² IV, q3w)

DRUG

Trifluridine/Tipiracil Hydrochloride

TAS-102 (25 mg/m² orally, days 1-5 and 8-12).

RADIATION

Short-course radiotherapy

(25 Gy/5 fractions)

RADIATION

intracavitary brachytherapy

brachytherapy (3 Gy/3 fractions).

Trial Locations (1)

310016

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Sir Run Run Shaw Hospital

OTHER