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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Pucotenlimab (200 mg IV, q3w)
Bevacizumab (7.5 mg/kg IV, q3w)
Oxaliplatin (130 mg/m² IV, q3w)
TAS-102 (25 mg/m² orally, days 1-5 and 8-12).
(25 Gy/5 fractions)
brachytherapy (3 Gy/3 fractions).
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Organ preservation rate
The organ preservation rate was calculated as the percentage of participants who achieved cCR and were spared from total mesorectal excision (TME) surgery relative to the total study cohort. Clinical complete response (cCR) requires both histopathological confirmation (no viable tumor cells in biopsy specimens) and radiographic confirmation (absence of tumor on CT, MRI, or PET-CT).
Time frame: Up to 2 weeks (once evaluation or biopsy is done)
Total mesorectal excision rate
Population who not achieve complete clinical response and have TME surgery after total neoadjuvant therapy
Time frame: After 2 weeks (once biopsy or local excision is done)
Total mesorectal excision rate after recurrence
Population who recurrent and have Salvage total mesorectal excision after achieving complete clinical response after total neoadjuvant therapy
Time frame: Through study completion, an average of 3 year
Tumor regression grade
Tumor Regression Grade(TRG)will be done via pathologic assessment on the surgical specimen with AJCC/CAP TRG system
Time frame: After 2 weeks (once biopsy or local excision is done)
Overall survival
The proportion of participants who remain survival at 3 years
Time frame: Up to 3 years
Progression free survival
The proportion of participants who remain progression free at 3 years
Time frame: Up to 3 years
TRAEs
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Time frame: Up to 3 years
Surgical Complications
Surgical Complications of biopsy, local excision or total mesorectal resection procedure for patients as assessed by Clavien-Dindo classification.
Time frame: Up to 3 years
QoL
Quality of life of the patients in total neoadjuvant settings as assessed by Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire liscenced from The Functional Assessment of Chronic Illness Therapy System ("FACIT System"). By using the Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores. The higher the score, the better the QOL.
Time frame: Up to 3 years
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