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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
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
Conditions
Interventions
Pucotenlimab
Pucotenlimab (200 mg IV, q3w)
Bevacizumab
Bevacizumab (7.5 mg/kg IV, q3w)
Oxaliplatin
Oxaliplatin (130 mg/m² IV, q3w)
Trifluridine/Tipiracil Hydrochloride
TAS-102 (25 mg/m² orally, days 1-5 and 8-12).
Short-course radiotherapy
(25 Gy/5 fractions)
intracavitary brachytherapy
brachytherapy (3 Gy/3 fractions).
Locations (1)
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China