locally advanced rectal adenocarcinoma
Conditions
Interventions
Test group:Treatment regimen: AK112 combined with mFOLFOX6.
Patients with locally advanced rectal cancer were treated with AK112 combined with mFOLFOX6 neoadjuvant therapy for 4 cycles. Imaging evalua
patients with ineffective neoadjuvant therapy (progressive or stable) were directly treated with simultaneous chemoradiotherapy. Neoadjuvant treatment regimen: AK112 20 mg/kg intravenous infusion on t
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent and join the study voluntarily; 2. Histological diagnosis of rectal adenocarcinoma; 3. CT and laparoscopy confirmed the clinical stage as cT4a/bN+M0 (according to AJCC 8th edition staging) colorectal adenocarcinoma; 4. Have not received anti-tumor therapy before; 5. Plan to undergo surgical treatment after the completion of neoadjuvant therapy; 6. Age 18-75 years old, male or female; 7. ECOG-PS score 0-1; 8. Expected survival =3 months; 9. Women of childbearing age must have a serum pregnancy study done within 7 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must consent to contraception within 24 weeks from the date of signing the informed consent to the last administration of the study drug; 10. Before the first dose of the investigational drug, the laboratory test value meets the following conditions: (1) blood routine (no blood transfusion within 14 days before screening, no hematopoietic stimulating drug correction) : white blood cell count (WBC) >=3.0 × 10^9/L; absolute neutrophil count (ANC) >=1.5 × 10^9/L; platelet (PLT) >=100 × 10^9/L; hemoglobin content (hemoglobin, HGB) >=9.0 g/dL; (2) Liver function: aspartate transferase (AST) =50 mL/minute (using Cockcroft/Gault formula); (4) Coagulation function: international normalized ratio (INR) 1.5 x ULN without clinical or imaging evidence of pancreatitis can be included in the group); Amylase 1.5 x ULN has no clinical or imaging evidence of pancreatitis, it can be included in the group); alkaline phosphatase (ALP) <=2.5ULN.
Exclusion criteria
Exclusion criteria: 1. Concurrent with other malignant tumors =5 years before the first dose; 2. Active, known or suspected autoimmune diseases include, but are not limited to, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus rheumatoid arthritis, inflammatory bowel disease, etc. 3. Prior treatment with any T cell co-stimulation or immune checkpoint, including but not limited to cytotoxic T lymphocyte-associated antigen-4, CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs that target T cells; 4. Use of corticosteroids (> 10 mg/ day prednisone or equivalent dose) or other immunosuppressants within =14 days prior to the first dose of the study drug. Allowing inhaled or topical use of steroids and adrenal replacement steroids in the absence of active autoimmune disease; 5.HBsAg positive and HBV DNA copy number greater than the upper limit of normal value in the laboratory of the research center (1000 copy number /ml or 500IU/ml), or HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection); Known HIV positive history or known Acquired Immune Deficiency Syndrome (AIDS); 6. Severe infection at enrollment, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 7. Had undergone major surgery within 28 days prior to enrollment or planned to undergo other major surgery during the study period; 8. Use of live attenuated influenza vaccine within 28 days prior to enrollment, or anticipated use of such live attenuated influenza vaccine during the study period (patients are not allowed to receive live attenuated influenza vaccine 4 weeks prior to enrollment, during treatment, and within 5 months after the final administration of the study drug); 9. Severe cardiovascular disease, such as New York Heart Association (NYHA) grade 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months prior to enrollment; 10. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; 11. Known allergy to the investigational drug or excipient, known severe allergic reaction to any monoclonal antibody; 12. Received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF; 13. In the investigator's judgment, the subjects had other factors that might have led to the forced termination of the study, such as non-adherence to the protocol, other serious medical conditions (including mental illness) requiring combined treatment, serious laboratory abnormalities, family or social factors that would have affected the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response (MPR);Objective response rate (ORR) ;R0 resection rate; | — |
Countries
China
Contacts
Public ContactRen yixing
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed