Colorectal cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab Combined CAPOX
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The pathology was confirmed as rectal adenocarcinoma, with a baseline clinical stage of T3-4 and/or N+; 2.Not receiving chemotherapy or any other anti-tumor treatments (including radiotherapy, chemotherapy, surgery) before enrollment; 3.ECOG score 0-1 points; 4.Female subjects of childbearing age agree to abstain from sexual intercourse or use reliable and effective methods of contraception from the time of signing the informed consent form until at least 90 days after the last dose of the study drug. 5.All subjects must sign an informed consent form before starting the research-related procedures. 6.Expected survival period >= 12 weeks; 7.At least 1 measurable lesion (according to RECIST 1.1 criteria); 8.It was evaluated by researchers that radical resection could be performed before enrollment. 9.The distance from the tumor to the anal verge is <= 10 cm
Exclusion criteria
Exclusion criteria: 1.It is known that there is a severe allergic reaction to macromolecular protein preparations and the ingredients or excipients of QL1706, capecitabine, and oxaliplatin. 2.Having undergone major organ surgery or suffered significant trauma within the first 28 days before initial use; 3.Received an attenuated live vaccine within 28 days before the first dose of medication or is expected to receive an attenuated live vaccine during the study treatment period; 4.Received systemic corticosteroids or other immunosuppressive therapy within 14 days before the first dose of the study drug, or is expected to require such therapy during the study treatment period; 5.History of active autoimmune diseases requiring systemic treatment or a history of autoimmune diseases within 2 years before the first medication; 6.A severe systemic infection occurred within 28 days before the first dose, and an active infection that required intravenous or oral antibiotic treatment occurred within 14 days before the first dose. 7.Have previously received organ transplantation/allogeneic bone marrow transplantation or are waiting for organ transplantation/allogeneic bone marrow transplantation; 8.With a history or evidence of interstitial lung disease or active non-infectious pneumonia; 9.With bleeding tendency and high risk of bleeding; 10.Thromboembolic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., that occurred within 6 months before the start of the study treatment. 11.Patients with congenital or acquired immunodeficiency (such as HIV ); 12.Active hepatitis (for reference in hepatitis B: HBsAg positive and HBV DNA >= 2000 IU/ml; for reference in hepatitis C: HCV antibody positive and HCV virus copy number > upper limit of normal value); 13.There are poorly controlled clinical symptoms or diseases of the heart, such as: (1) Cardiac insufficiency above grade II according to the New York Heart Association (NYHA) criteria or color Doppler echocardiography showing LVEF (left ventricular ejection fraction) 450ms (male) or QTc > 470ms (female) in resting electrocardiogram examination. 14.Those who have suffered from other malignant tumors within 5 years before enrollment, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix. 15.Received other unmarketed clinical research drugs or treatments within 4 weeks before the first dose; 16.Women during pregnancy or lactation; 17.Other situations that researchers assess as inappropriate for participation in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rate of neoadjuvant therapy with TNT;pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Removal rate of R0;Rate of anal preservation;Three-year disease-free survival rate (DFS);The incidence and severity of adverse events (AE) and serious adverse events (SAE) were determined according to the NCI-CTCAE v5.0 standard.;Overall Survival (OS);Three-year event-free survival rate (EFS);TRG score;Abnormalities in vital signs, physical examination, ECOG performance status, laboratory tests, 12-lead ECG, etc.;The changes in the scores of the Cancer Patient Quality of Life Measurement Questionnaire (EORTC QLQ-C30) reported by the subjects during the study compared to the baseline values; | — |
Countries
China
Contacts
Public ContactLiu Jinbo
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed