Rectal cancer
Conditions
Interventions
Experimental Group:Before surgery, each subject received 1 cycle of CAPOX regimen ?2 cycles of QL1706 (5 mg/kg, i.v. q3w) combined with CAPOX regimen ? short-course radiotherapy (25Gy/5f)? 3 cycles of
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender not limited; 2. Subjects with rectal cancer confirmed by histopathology (cT3-4N0M0 or cTxN+M0, stage II-III, AJCC 8th Edition); 3. Immunohistochemical (IHC) biopsy tissues indicated complete mismatch repair function (pMMR), that is, all four proteins, MSH1, MSH2, MSH6, and PMS2, were positive, or genetic testing suggested MSS/MSI-L; 4. Has not received systemic treatment in the past; 5. Measurable or evaluable lesions as defined by the RECIST v1.1 standard; 6. The ECOG performance status score is 0 or 1; 7. The distance between the lower edge of the tumor and the anal margin is no more than 12cm. 8. No symptoms of intestinal obstruction, or the intestinal obstruction is alleviated after proximal colostomy. 9. No rectal surgery was performed except for preventive stoma. 10. It has adequate organ and bone marrow functions, defined as follows: hemoglobin > = 9.0 g/dL; Absolute neutrophil count > = 1.5 ×10^9/L; Platelet count > =100×10^9/L; INR 60 mL/min or creatinine clearance > 60 mL/min calculated according to the Cockcroft-Gault formula (using actual weight) : Male: Creatinine clearance = (weight × (140- age))/(72× serum creatinine) Female: Creatinine clearance rate = (body weight × (140-age))/(72× serum creatinine) ×0.85, where CL = mL/min; Serum creatinine = mg/dL; 11. Patients with active HBV infection should receive antiviral treatment for more than two weeks in accordance with local antiviral treatment guidelines before enrollment, and should continue treatment for six months after the study drug treatment. 12. Expected survival period >=3 months; 13. Voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. IHC biopsy showed mismatch repair deficiency (dMMR), that is, at least one of the four proteins MSH1, MSH2, MSH6, PMS2 was missing, or genetic testing showed MSI-H; 2. Patients with a history of HIV infection; 3. Patients with a history of organ transplantation; 4. Active or documented autoimmune or inflammatory diseases (including inflammatory bowel disease [e.g., "Colitis or Crohn's disease], diverticulitis (except diverticulosis), systemic lupus erythematosus, sarcoidosis syndrome, or Wegener's syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, among others])." The following are exceptions to this standard: (a) patients with vitiligo or alopecia; (b) patients with hypothyroidism (e.g., after Hashimoto syndrome) receiving stable hormone replacement therapy; (c) any chronic skin condition requiring systemic treatment; (d) Patients who had been free of active disease in the previous 5 years could be enrolled, but only after consultation with a study physician; (e) people with celiac disease that can be controlled with diet alone; 5. Active infection, including tuberculosis (clinical evaluation includes clinical history, physical examination, imaging findings, and tuberculosis examination in accordance with local treatment principles); 6. Uncontrolled complications including, but not limited to, persistent or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled cardiac arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease with diarrhea; Or a mental illness/social condition that limits adherence to study requirements, significantly increases the risk of developing an AE, or impairs the patient's ability to provide written informed consent; 7. Had abnormal thyroid function in the past, and the thyroid function could not be maintained in the normal range despite drug treatment; 8. Current or previous use of immunosuppressive drugs within 14 days before the first dose. The following are exceptions to this standard: (a) an intranasal, inhaled, topical steroid or a topical injected steroid (e.g., an intra-articular injection); (b) a systemic glucocorticoid not exceeding a physiological dose, equivalent to 10 mg/ day of prednisone or its equivalent; (c) steroid hormones as a pretreatment for hypersensitivity (e.g., CT scan pretreatment); 9. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 10. Live attenuated vaccine administered within 30 days before the first dose of study drug. Note: If enrolled, patients were not allowed to receive live vaccine while receiving the study drug and for 30 days after the last dose of the study drug. 11. Known to have an allergic or hypersensitive reaction to any study drug or any excipients thereof; 12. Other conditions deemed by the investigator to be ineligible for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor regression grading by MRI;Objective response rate, ORR;MPR;Safety;Overall survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWu Xiaojin
Xuzhou Central Hospital
Outcome results
None listed