Colorectal cancer
Conditions
Interventions
dMMR/APC-WT group and dMMR/APC-Mut group:Iparomlimab and Tuvonralimab Injection: 5.0mg/kg, intravenous infusion on day 1, repeated every 21 days, for a maximum of 2 years
pMMR/APC-WT group and pMMR/APC-Mut group:(1) Iparomlimab and Tuvonralimab Injection: 5.0mg/kg, intravenous infusion on day 1, repeated every 21 days, for a maximum of 2 years
(2) Bevacizumab: 7.5mg/kg, intravenous infusion on day 1, repeated every 21 days
(3) CAPOX regimen (Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 bid d1-14), repeated every 21 days.
Sponsors
Southern Hospital Ganzhou Hospital (Ganzhou People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, age must be >= 18 and = 3.0 10^9/L, PLT>= 50*10^9/L, Hgb>= 80*10^9/L; ALT= 28g/L; CCr>= 80ml/min; 6.At least one measurable lesion according to the mRECIST criteria; 7.ECOG score of 0-1; 8.Expected survival time of more than 3 months; 9.Willing and able to accept follow-up until death or the end of the study or the study is terminated; 10.Willing and able to undergo follow-up until death or study completion or study termination;
Exclusion criteria
Exclusion criteria: 1.ECOG score >= 2 points; 2.Lesions located in the left-sided colorectum with RAS wild-type; 3.Patients with severe functional impairment of vital organs (heart, liver, kidney); 4.Known hypersensitivity or allergic reactions to any component of the study treatment; 5.History of organ transplantation, autologous/allogeneic stem cell transplantation; 6.Receiving chronic systemic immunotherapy or physiological replacement therapy other than hormone therapy; 7.Any unstable systemic disease: active infection, uncontrolled severe hypertension, unstable angina, angina that has begun to occur within the last 3 months, congestive heart failure (New York Heart Association [NYHA] >= grade II), myocardial infarction within 6 months prior to enrollment, severe arrhythmias requiring medication, gastrointestinal bleeding or active bleeding tendency within the last month; 8.Patients with other untreated malignant tumors, excluding carcinoma in situ at other sites; 9.Any disease, metabolic disorder, or suspicion from physical examination or laboratory tests that the patient has contraindications to the study drug or has high-risk factors for treatment complications; 10.Pregnancy or lactation; 11.Other adverse health conditions or mental states that the researcher believes may affect the compliance with the protocol and the assessment of trial endpoints, making the subject unsuitable for the study; 12.Lack of legal capacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Countries
China
Contacts
Public ContactChen Tao
Southern Hospital Ganzhou Hospital (Ganzhou People's Hospital)
Outcome results
None listed