Rectal Cancer
Conditions
Interventions
Test group:Camrelizumab + XELOXIRI Chemotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 75 years old, male or female; 2) Histologically or cytologically confirmed rectal cancer with a measurable tumour lesion (=10mm on spiral CT or MR scan, meeting RECIST 1.1 criteria); 3) Patients with MRI assessment of stage II (T3-4N0M0) or stage III (T1-4N1-2M0) rectal cancer with distal margin <12 cm from the anal verge ); 4) ECOG PS score: 0-1; 5) No peritoneal metastasis or other distant metastasis; Note: the presence of distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, PET-CT should be performed or laparoscopy should be performed. If brain metastases are suspected, CT or MR should be performed; 6) Primary patients who have not received prior systemic chemotherapy, radiotherapy, local excision, or immune checkpoint inhibitor therapy for colorectal cancer; 7) Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors during the screening period) a) Absolute neutrophil count = 1.5 x 10*9/L; platelets = 100 x 10*9/L; haemoglobin = 8.5 g/dL; b) Thyrotropin (TSH) =1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be enrolled); c) Bilirubin =1.5 times ULN; ALT and AST =2.5 times ULN; d) Serum creatinine =1.5 times ULN. 8) Women of childbearing potential must have a negative pregnancy test (ßHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months following administration of the last therapeutic dose; 9) Subjects voluntarily enter the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding women, or those of childbearing potential who refuse to use contraception; 2) A history of other malignant tumours in the last 5 years 3) Tumours that are expected to be unresectable after neoadjuvant therapy; 4) Patients who have undergone major surgery within the last 6 months and have not recovered from the side effects of that surgery; 5) Uneffectively controlled, symptomatic brain metastases or those with a history of psychosis that cannot be easily controlled or severe intellectual or cognitive dysfunction; 6) Pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis and severely impaired lung function 7) Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, and skin disorders (e.g., vitiligo, psoriasis, or alopecia areata) that do not require systemic therapy may be eligible for enrolment; 8) Patients with congestive heart failure, difficult-to-control arrhythmias, myocardial infarction within 6 months, unstable angina, stroke or transient ischaemic attack, or otherwise unable to tolerate surgery; 9) Known peripheral neuropathy; 10) Severe active infections requiring intravenous antibiotic therapy occurring during the screening period; 11) Allergy to the test drug; 12) Have received or will receive a live vaccine within 30 days prior to karelizumab administration; 13) Known history of HIV infection; 14) Patients who cannot tolerate chemotherapy; 15) Patients who are unable to comply with the trial protocol or cooperate with follow-up visits; 16) Patients who, in the opinion of the investigator, should not participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neoadjuvant Rectal Score;objective response rate;tumor regression grade;Disease-free survival;overall survival;safety;Quality of life assessed by EORTC QLQ-CR29 ; | — |
Countries
China
Contacts
Public ContactBinbin Cui
Harbin Medical University Cancer Hospital
Outcome results
None listed