This study investigates the efficacy of neoadjuvant radiotherapy combined with QL1706 in MSS-type low-grade rectal cancer. This study is a prospective multicohort study, with cohort 1 intended to include patients with low grade early rectal cancer (cT1-3N0M0) and cohort 2 intended to include patients with low grade locally advanced rectal cancer (cT4N0M0 or cTanyN+M0). Each cohort included 30 subjects receiving neoadjuvant radiotherapy combined with QL1706 treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Using a short-course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 25 Gy (5 Gy/treatment × 5 treatments); 2 weeks of rest after the end of radiotherapy were followed by 4 cycles of Capoex combined with QL706.
Using a long course radiotherapy treatment protocol, the primary tumor and high-risk areas were irradiated with a tumor dose of 50 Gy (2 Gy/treatment x 25 treatments); a 2-week break at the end of radiotherapy was followed by 4 cycles of Capoex combined with QL706.
Complete Response Rate
Includes clinical complete response rate (cCR) and pathologic complete response rate (pCR)
Time frame: After neoadjuvant therapy 1 month or after surgery 1 month
Overall survival
Overall survival
Time frame: 3 years /5 years
Disease Free survival
Disease Free survival
Time frame: 3 years /5 years
Wexner Fecal Incontinence Score (Wexner Score)
Evaluates the severity of fecal incontinence (frequency and type). Includes frequency of solid/liquid/gas incontinence, need for pad use, and impact on daily life. Total score ranges from 0-20; higher scores indicate more severe incontinence (0 = full control, 20 = complete incontinence).
Time frame: After neoadjuvant therapy 3 months or after surgery 3 months
Low Anterior Resection Syndrome Score (LARS Score)
Assesses bowel dysfunction (LARS syndrome) in patients after low anterior resection for rectal cancer. Includes abnormal bowel frequency, urgency/incontinence, fragmented defecation, and difficulty emptying the bowel. Total score ranges from 0-42, categorized as no LARS (0-20), minor LARS (21-29), or major LARS (≥30). Higher scores indicate worse symptoms; lower scores are better.
Time frame: After neoadjuvant therapy 3 months or after surgery 3 months
Short-Form 36 Health Survey (SF-36 Score )
Broadly evaluates quality of life across eight domains: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain is scored 0-100; higher scores reflect better health in that domain. Higher total scores are better (100 = optimal health status).
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Time frame: After neoadjuvant therapy 3 months or after surgery 3 months