To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma.
At present, neoadjuvant chemoradiotherapy (nCRT) combined with total mesorectal excision (TME) is the main standard treatment, and the choice of treatment modalities is limited. The emergence of immunotherapy has provided a new direction for the exploration of neoadjuvant therapy for rectal adenocarcinoma. At the same time, a number of studies have also shown that appropriate radiotherapy intensity can promote immune response. Therefore, the investigators intend to conduct the clinical trail to explore the effect of short-course radiotherapy combined with PD-L1 combined and chemotherapy as TNT (total neoadjuvant therapy) on organ retention rate in patients with With MSS/pMMR Ultra Low Rectal Adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
130mg/m2, ivgtt, d1, Q3W
1000mg/m2, po, bid, d1-14, Q3W
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGOrgan retention rate
population who achieve complete clinical response after total neoadjuvant therapy
Time frame: After 2 weeks (once biopsy or local excision is done)
Total mesorectal excision rate
population who not achieve complete clinical response 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: from primary evaluation at 2 weeks after total neoadjuvant therapy finished
Tumor regression grade
Tumor regression grade following short-course radiation then Envafolimab Plus CAPEOX as assessed by 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
Disease free survival
The time from randomization to the first event of either recurrent disease or death
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
QoL
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Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.
local excision or TME surgery (total mesorectal excision) Biopsy can choose endoscopic or needle biopsy, colcal excision refers to excison of the local lession after total neoadjuvant therapy. The total mesorectal excision can choose open, laparoscopic or robotic according to the specific condition of the patient.
Quality of life of the patients in total neoadjuvant settings of short-course radiation followed with Adebrelimab Plus CAPEOX 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