locally advanced rectal adenocarcinoma
Conditions
Interventions
Research group:Short-term radiotherapy+evoximab +CAPOX regimen chemotherapy
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form, and be able to abide by the visit arrangements and related procedures stipulated in the plan. 2. Age >=18 and =90g/L Absolute count of neutrophils (ANC) >=1.5×10^9/L Platelet Count >=100×10^9/L White blood cell count >= 3.0×10^9/L Serum biochemical examination at baseline meets the following requirements : total bilirubin = 45ml / MIn, Cockcroft-Gault formula is used to calculate ccr (using actual body weight); albumin >= 30g /L. Coagulation examination at baseline meets the following requirements : International Normarized RATIO (InR) =50%; 11. Female subjects with fertility need to have a serum pregnancy test within 14 days before starting the drug administration, and the results are negative, and take effective contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the trial period and at least 6 months after the last drug administration; For male subjects whose partners are fertile women, effective contraceptive measures should be taken during the trial and within 6 months after the last administration.
Exclusion criteria
Exclusion criteria: 1. Previous allergic history to any anti-angiogenesis targeted drugs, any component of monoclonal antibodies, capecitabine, oxaliplatin or other platinum drugs; 2. Have received or are receiving any of the following treatments in the past: (1) being treated with immunosuppressive drugs or systemic hormone drugs within 2 weeks before using the study drug for the first time to achieve the purpose of immunosuppression (dosage > 10mg/ day of prednisone or equivalent dosage); In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and prednisone with a dose of > 10mg/ day or adrenocortical hormone with an equivalent dose; (2) Received live attenuated vaccine within 4 weeks before the first use of the study drug; (3) Undergoing major surgery or serious trauma within 4 weeks before the first use of the study drug; 3. Suffering from any active autoimmune disease or autoimmune disease history, including but not limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism (after hormone replacement therapy, it can be considered); Patients with psoriasis or childhood asthma/allergy who have been completely relieved and do not need any intervention after adulthood can be considered for inclusion, but patients who need medical intervention with bronchodilators cannot be included; 4. Have a history of immunodeficiency disease, including HIV positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation; 5. There are cardiac clinical symptoms or diseases that are not well controlled, including but not limited to: (1) heart failure above NYHA II, (2) unstable angina pectoris, (3) myocardial infarction within one year, (4) clinically significant supraventricular or ventricular arrhythmia that is still not well controlled without clinical intervention or clinical intervention; (5) Patients with hypertension who cannot be well controlled by single antihypertensive drug treatment (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100mmHg), or patients who use two or more antihypertensive drugs to control their blood pressure; 6. Serious infection occurred within 4 weeks before the first use of the study drug (CT CAE > grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization; Baseline chest imaging examination indicates active lung inflammation, symptoms and signs of infection within 14 days before the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for preventive use of antibiotics; 7. Those who have found active pulmonary tuberculosis infection through medical history or CT examination, or those who have had a history of active pulmonary tuberculosis infection within one year before joining the group, or those who have had a history of active pulmonary tuberculosis infection more than one year ago without formal treatment; 8. Active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL) and hepatitis C (hepatitis C antibody is positive and HCV RNA is higher than the detection limit of analytical method) exist; 9. The patient has a second primary malignant tumor; 10. Pregnant or lactating women; 11. Arterial/venous thrombosis events have occurred within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep venous throm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life score;safety;3-year event-free survival rate;adverse event;R0 resection rate;surgical safety;overall survival; | — |
Countries
China
Contacts
Public ContactTao Zhang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed