This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation.
This study plans to recruit 48 patients with locally advanced/low anal preservation requiring rectal cancer. The study aims to observe and evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Camrelizumab IV 200mg
Capecitabine PO oxaliplatin IV
Radiotherapy 50Gy /45Gy /25 fractions
Pathological Complete Response rate
After neoadjuvant therapy and surgery, postoperative specimens showed no residual surviving tumor cells in the tumor bed (%RVT=0).
Time frame: up to 24 months
Objective Response Rate
Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Time frame: up to 24 months
Disease Control Rate
Determined using RECIST v1.1 criteria.
Time frame: up to 24 months
Anal preservation rate
Proportion of patients with low rectal cancer who retain their anus after surgery.
Time frame: up to 24 months
Disease-free Survival
The time from surgical resection to the first tumor recurrence and metastasis, or the patient's death due to any reason.
Time frame: up to 24 months
Overall Survival
Defined as the time from randomizstion to death from any cause.
Time frame: up to 36 months
AEs
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to 24 months
3-years Overall Survival rate
Proportion of death from randomization to 3 years of treatment.
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Time frame: up to 36 months