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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

NCT06872606 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-03-12

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-01
Completion
2028-04-01

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06872606 on ClinicalTrials.gov