Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the total neoadjuvant therapy mode for locally advanced ultra low rectal cancer to preserve the organs. In view of the shortcomings of the current otal neoadjuvant therapy model for locally advanced ultra low rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 8 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy for the poplation who can be achieved organ preservation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Drug: Envafolimab This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW). Other Names: KN053 Drug: Oxaliplatin 130mg/m2,ivgtt,d1 Drug: Capecitabine 1000mg/m2,po,bid,d1-14 Radiation: Short-course Radiation 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. Procedure/Surgery: Biopsy, 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.
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGOrgan reservation 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 f
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
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 after short-course radiation then Envafolimab Plus CAPEOX as assessed by Clavien-Dindo classification
Time frame: Up to 3 years
QoL
Quality of life of the patients in total neoadjuvant settings of short-course radiation followed with Envafolimab 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
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