About this trial
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.
Eligibility criteria
Qualifiers
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,
Disqualifiers
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,
Trial design
Treatments tested in this trial
- Camrelizumab
- Chemotherapy
- Radiotherapy