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NOT YET RECRUITING
NCT06872606
PHASE2

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

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer. This is a Non-Randomized, Single Group Assignment, Open Label, Phase: Phase II study. The Primary Objective is to assess the organ preservation rate (clinical complete response, cCR) after total neoadjuvant therapy. Secondary Objectives are Tumor regression grade (TRG), 3-year overall survival (OS) and disease-free survival (DFS), and Safety and quality of life (QoL). In this study, the investigators will perform the multi-dimensional omics study to explore the tumors microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.

Official title: The Efficacy and Safety of 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 Adenocarcinoma: an Prospective, Single Arm Clinical Trial (SCRIPBOT Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-04-01

Completion Date

2028-04-01

Last Updated

2025-03-12

Healthy Volunteers

No

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).

Locations (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China