This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5\*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
Radiotherapy protocol: 5 × 5Gy short-term radiotherapy (D1-5 in the first week) Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ~ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme.
Radiotherapy regimen: long-term radiotherapy 1.8 × 25-28Gy, oral capecitabine in the same period: the standard dose is 825mg/m2, twice a day \[total dose 1650mg/(M2 · d)\], oral radiotherapy day, 5 days a week. Immunotherapy regimen: Adebrelimab 1200 mg or 20 mg/kg, IV., administered on the first day of each chemotherapy cycle. Chemotherapy regimen: capox regimen: Oxaliplatin 130 mg/m2 IV D1 Capecitabine 1000 mg/m2 Po bid D1 ~ 14 Repeat every 3 weeks for 6 cycles The curative effect was evaluated 2-3 weeks after the completion of 6 cycles of chemotherapy. According to whether the CCR (clinical complete remission) was achieved, TME surgery was required if the CCR was not achieved; If CCR is achieved, TME operation can be performed according to the wishes of the patients. Local resection or observation through anal surgery requires close follow-up to explore the effectiveness and safety of the scheme.
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
RECRUITINGCR rate
pathological complete remission rate (PCR) and clinical complete remission rate (CCR)
Time frame: From enrollment to the end of surgery,assessed up to 6 months
partial remission rate (PR)
the total diameter of all measurable target lesions is ≥ 30% lower than the baseline
Time frame: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Objective response rate (ORR)
Proportion of subjects defined as complete remission (CR) and partial remission (PR) in total subjects
Time frame: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Major Pathological Response Rate (MPR)
Major Pathological Response Rate (MPR)
Time frame: From enrollment to the end of surgery,assessed up to 6 months
R0 resection rate
There is no visible tumor residue in the body, and no residual tumor cells are found under the pathological microscope
Time frame: From enrollment to the end of surgery,assessed up to 6 months
2-year DFS rate
2-year progression free survival rate
Time frame: The longest follow-up time was 2 years from enrollment to disease progression
3-year OS rate
3-year OS rate
Time frame: The longest follow-up time was 3 years from enrollment to death from any cause
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