NCT06872606

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

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）

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Adenocarcinoma

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2028-04-01
• First posted: 2025-03-12
• Last updated: 2025-03-12

Locations

1 site across 1 country: China