rectal cancer
Conditions
Interventions
Case series:Sintilimab + Radiation therapy + Oxaliplatin + capecitabine
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent prior to the implementation of any procedure related to the test; 2. Male or female, age =18 years old; 3. ECOG score 0-1; 4. Primary rectal adenocarcinoma confirmed by histopathology; 5. In patients with clinical stages t3/4 or N+M0, the lower edge of the tumor was = 10cm from the anal edge in combination with endoscopic ultrasonography/rectal MR scan diagnosis, and the lesion was evaluated to be resectable surgically; 6. According to the therapeutic efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one lesion can be measured by imaging; 7. The patient has not received any previous anti-tumor therapy, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc 8. Subjects shall meet the following laboratory indicators for adequate organ function: 1) When granulocyte colony stimulating factor was not used for the last 14 days, the absolute value of neutrophil (ANC) was =1.5x109/L. 2) Platelets =100×109/L in the last 14 days without blood transfusion. 3) Hemoglobin & GT in the absence of blood transfusion or erythropoietin in the last 14 days;9 g/dL. 4) Total bilirubin =1.5× upper limit of normal value (ULN); 5) Aspartate transaminase (AST) and alanine transaminase (ALT) were =2.5×ULN; 6) Serum creatinine =1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) =60 ml/min; 7) Good coagulation function, defined as international standard ratio (INR) or prothrombin time (PT) =1.5 times ULN; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range.If baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled. 9) The myocardial enzyme spectrum is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality with no clinical significance is also allowed to be included). 9. For female subjects of childbearing age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required.Women of non-reproductive age were defined as having at least 1 year after menopause, or had undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (male or female) are required to use a contraceptive with an annual failure rate of less than 1% throughout the treatment period up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of distant metastasis by CT /MR/ EUS; 2. Has other malignant neoplasms (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ) in the past 5 years; Severe ileus; 3. 4. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration; 5. Have received the following therapies previously: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting another type of stimulation or synergistic inhibition of T cell receptors (for example, CTLA-4, Ox-40, CD137); 6. Received Chinese patent medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukinin, except for local use to control pleural effusions) systemic treatment within 2 weeks before the first administration; 7. An active autoimmune disease requiring systemic treatment (such as the use of disease-alleviating drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration.Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic; 8. Was receiving systemic glucocorticoid therapy (excluding nasal spray, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days of the first administration; Note: A physiological dose of glucocorticoid (prednisone or its equivalent =10 mg/ d) is allowed; 9. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known; 10. Allergic to the active ingredient or excipient of xidilizumab, the drug in this study; 11. Having multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 12. Has not fully recovered from toxicity and/or complications due to any intervention prior to initiation of treatment (i.e., = grade 1 or baseline, excluding fatigue or hair loss); 13. A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg positive detected with more copies of HBV-DNA than the upper limit of normal value in the laboratory of the research center); Note: Hepatitis B subjects who meet the following criteria may also be enrolled: 15. HBV viral load before first administration & LT;1000 copies /ml (200 IU/ml), subjects should receive anti-HBV treatment to avoid reactivation of the virus throughout the study chemotherapy drug treatment; 16. For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-), and HBV viral load (-), prophylactics of anti-HBV therapy is not required, but virus reactivation needs to be closely monitored. 17. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 18. Live vaccine was administered within 30 days prior to the first administration (cycle 1, day 1); Note: Inactivated vaccine for seasonal influenza is allowed within 30 days of initial administration;But live attenuated intranasal flu vaccines are not allowed. 19. Pregnant or lactating women; 20. The presence of any serious or uncontrolled systemic disease, such as: 1) resting electrocardiogram (ecg) in rhythm, conduction, or form of significant and severe symptoms are difficult to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| cCR;MPR;DFS;OS; Sphincter-preserving rate;R0 resection rate;AEs; | — |
Countries
China
Contacts
Public ContactHaitao.Yin
xuzhou central hospital
Outcome results
None listed