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.
Age: 18 to 75 years old, male or female,
Histologically or cytologically confirmed rectal cancer with measurable tumour lesions (Spiral CT or MR scans ≥ 10 mm, meeting RECIST 1.1 criteria),
Clinical stage: Rectal cancer cT3-4N0M0 or cT1-4N+M0 and low rectal cancer with need for anal preservation (<5 cm from anal verge; T2N0M0),
Expected survival > 3 months,
Previous pelvic or abdominal radiotherapy,
Tumours that are expected to be unresectable after neoadjuvant therapy,
Pregnant or lactating women, or those of childbearing potential who refuse to use contraception,
History of other malignancies within the past 5 years, except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or basal cell carcinoma of the skin that has been substantially controlled,
Single group
Camrelizumab
DrugCamrelizumab IV 200mg
Chemotherapy
DrugCapecitabine PO oxaliplatin IV
Radiotherapy
RadiationRadiotherapy 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).
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.
Disease Control Rate
Determined using RECIST v1.1 criteria.
Anal preservation rate
Proportion of patients with low rectal cancer who retain their anus after surgery.
Disease-free Survival
The time from surgical resection to the first tumor recurrence and metastasis, or the patient's death due to any reason.
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