Rectal adenocarcinoma
Conditions
Interventions
One:Arterial Infusion chemotherapy plus ivonescimab
Sponsors
Tianjin Union Medical Center(The First Affiliated Hospital of Nankai University)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Enrollment Criteria: 1. Signed written informed consent before enrollment; 2. Age>=18 years old; 3. Patients with histologically or pathologically confirmed rectal adenocarcinoma; Patients with high rectal cancer (the lower edge of the tumor is >=10 cm from the anus) or rectal cancer with incomplete obstruction confirmed by imaging studies 4. Patients who have been diagnosed by imaging as initially unresectable, and have the potential to be transformed into resectable patients by MDT in the opinion of MDT; 5. Have not received systemic therapy in the past; 6. Have at least one measurable lesion (non-lymph node lesion CT scan long diameter >=10 mm, lymph node lesion CT scan short diameter >=15 mm) according to RECIST 1.1 criteria); 7. ECOG PS score: 0~1; 8. Expected survival greater than 12 weeks; 9. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): 10. Blood routine: Neutrophil >=1.5×109/L Platelet count >=100×109/L Hemoglobin >=90g/L; 11. Liver and kidney function: serum creatinine (SCr) =50 ml/min (Cockcroft-Gault formula); Liver function: aspartate aminotransferase (AST) =2+, the 24-hour urine protein quantification must show that the protein must be <= 1 g; 12. Normal coagulation function, no active bleeding and thrombotic diseases 13. International standardized ratio INR<= 1.5×ULN; 14. Partial thromboplastin time APTT<= 1.5×ULN; 15. Prothrombin time PT<= 1.5×ULN; 16. Non-surgically sterile or female patients of childbearing potential who need to use one medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during study treatment and for 3 months after the end of the study treatment period; Non-surgically sterilized female patients of childbearing potential must have a negative serum or urine HCG test within 7 days prior to study enrollment; and must be non-lactating. 17.The subjects voluntarily joined this study, with good compliance and safety and survival follow-up.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Patients with any of the following cannot be enrolled in this study: 18. Subject has previous or concurrent other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 19. Known subject has been allergic to macromolecular protein preparations in the past, or known to be allergic to the drug components applied; 20. Subject has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, and those who have undergone thyroid surgery in the past cannot be included; Subjects with vitiligo or who have had complete remission of asthma in childhood and do not need any intervention after adulthood may be included; Asthma in participants requiring medical intervention with bronchodilators could not be included); 21. Subjects are using immunosuppressants, or systemic or absorbable topical hormone therapy to achieve immunosuppressive purposes (dose> 10mg/day prednisone or other efficacy hormones), and continue to use them within 2 weeks before enrollment; 22. Clinically symptomatic ascites or pleural effusion requiring therapeutic puncture or drainage; 23. Patients with uncontrolled cardiac clinical symptoms or diseases that are not well controlled, such as: (1) NYHA level 2 or above heart failure (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 24. Subject has active infection or fever of unknown cause > 38.5 degrees during the screening period and before the first dose (as judged by the investigator, the subject can be enrolled due to the fever caused by the tumor); 25. Patients with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc. 26. Subject with congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (aminotransferases do not meet the inclusion criteria, hepatitis B reference: HBV DNA= 1000 IU/ml; Hepatitis C reference: HCV RNA =1000 IU/ml); Chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml, must receive antiviral therapy at the same time during the trial to be enrolled; 27. Live vaccine received less than 4 weeks before the study administration or possibly during the study period; 28. Subject has a known history of psychotropic substance abuse, alcoholism, or drug abuse; 29. Have received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose. In the opinion of the investigator, the subject should be excluded from this study, for example, in the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 excision conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Pathologic complete response rate;Major Pathological Response;Objective response rate based on RECIST v1.1 assessment;Progression-free survival;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactMa Chunhua; Xu Jing
Tianjin Union Medical Center(The First Affiliated Hospital of Nankai University)
Outcome results
None listed