This is a phase III, multi-center, double-blind randomized controlled trial assessing the efficacy and safety of concurrent mitomycin C/5-Fu chemotherapy and long-course IMRT combined with PD-1 antibody Sintilimab for locally advanced anal canal squamous carcinoma patients, by comparing an experiment group (traditional chemoradiotherapy with PD-1 antibody Sintilimab) with a control group (traditional treatment without Sintilimab).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Two cycles of concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil and IMRT, followed by adjuvant sintilimab for six months
Two cycles of concurrent mytomicin C and 5-fluorouracil combined with IMRT
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression free survival
progression free survival
Time frame: from the end of treatment to 3 years after treatment
Overall survival
overall survival
Time frame: from the end of treatment to 3 years after treatment
cCR rate
cCR rate 6 months after treatment
Time frame: 6 months after treatment
Acute toxicities
acute toxicities according to the NCI CTCAE (version 4.0)
Time frame: from the start of treatment to 3 months after treatment
cCR rate
cCR rate 3 months after treatment
Time frame: 3 months after treatment
The rate of late toxicity according to the RTOG/EORTC scale
The rate of late toxicity according to the RTOG/EORTC scale
Time frame: 3 years
Colostomy rate
colostomy rate
Time frame: 2 year
Local recurrence rate
local recurrence rate
Time frame: from the end of treatment to 3 years after treatment
Distant metastasis rate
distant metastasis rate
Time frame: from the end of treatment to 3 years after treatment
Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events
Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events
Time frame: 1 year
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