Patients with colorectal cancer
Conditions
Interventions
control group:Trifluridine and Tipiracil Hydrochloride Tablets
Bevacizumab Injection
treatment group:Iparomlimab and Tuvonralimab Injection?Trifluridine and Tipiracil Hydrochloride Tablets?Bevacizumab Injection
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance; 2.Age: 18 years or above, gender not limited; 3.It has been confirmed by histopathological examination that the patient has inoperable colorectal adenocarcinoma; 4.Has received at least one line of systemic treatment for advanced colorectal cancer in the past; 5.Screening patients with enriched pro-inflammatory macrophage subpopulations: Firstly, using RNAseq technology, the expression levels of genes related to pro-inflammatory panTAMs in the tumor microenvironment of patients ("WARS1", "CXCL10", "CXCL9", "GBP1", "GBP4", "GBP5", "IFIT3", "LAP3", "MX1", "PARP14", "PSMB9", "RSAD2", "SAMD9L", "STAT1", "TAP1") and genes related to pro-tumor panTAMs in the tumor microenvironment ("APOC1", "APOE", "CD63", "CTSB", "CTSD", "DBI", "FN1", "GSN", "LPL", "RGCC", "SDC2", "TREM2", "VIM", "SPP1") were detected; then, the gene expression data were transformed by Z-score, and the RandomForestClassifier analysis method (based on scikit-learn 1.3.0 in python) was used to calculate the respective panTAMs scores of these subpopulations, and the panTAMs score of the patient was obtained. 9 The above method was applied to calculate the panTAMs score of each patient in a large sample colorectal cancer dataset TCGA-COAD. The cutoff value was determined as 2.79 by the median (Median). The panTAMs score of the patient was compared with the cutoff value of 2.79 in the TCGA-COAD dataset to determine the position of the patient in the large sample. If the panTAMs score of the patient was greater than the cutoff value of 2.79, it was defined as a high score, and it was considered that the patient potentially benefited from immunotherapy; 6.ECOG:0~2; 7.According to the RECIST v1.1 standard, the subjects had at least one measurable tumor lesion; 8.The main organ functions are normal, which meets the following criteria: (1) Blood routine examination: a. HB >= 90g/L; b. ANC >= 1.5×10^9/L; c. PLT >= 80×10^9/L; (2) Biochemical examination: a. ALB >= 30g/L; b. ALT and AST = 60ml/min; 9.Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= lower limit of normal value (50%); 10.Fertile subjects: Must agree to abstain from sexual activity or use a reliable and effective contraceptive method from the time of signing the informed consent form until at least 90 days after the last administration of the study drug. And the serum or urine HCG test results of female subjects must be negative.
Exclusion criteria
Exclusion criteria: 1.Patients who are currently participating in other interventional clinical studies; 2.Pregnant and lactating women; 3.The patient has any active autoimmune disease or has a history of autoimmune disease; 4.The patient is currently undergoing immunosuppressive therapy, either with immunosuppressants or systemic hormones, with the aim of achieving immunosuppression (dose > 10mg/day of prednisone or other equivalent efficacy hormones), and has continued to use these medications within the previous 2 weeks before enrollment; 5.Patients with any severe and/or uncontrolled diseases are included, such as those with unsatisfactory blood pressure control (systolic blood pressure >= 170 mmHg or diastolic blood pressure >= 100 mmHg); patients with grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval >= 480 ms), and grade I cardiac insufficiency. 6.Active or uncontrolled severe infections; 7.Women who are pregnant or breastfeeding; 8.Patients who have suffered from other malignant tumors within the past 5 years (excluding cured cases of skin basal cell cancer and cervical carcinoma in situ); 9.Patients who have participated in other clinical trials of intervention drugs within the past four weeks; 10.During the 30-day period before the treatment began, the live virus vaccine was administered. Seasonal influenza vaccines without live viruses were permitted to be used; 11.Have a history of immunodeficiency, including a positive HIV test result, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 12.Having severe concomitant diseases or other coexisting conditions that would interfere with the planned treatment, or any other circumstances where the researcher deems the patient unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progression-Free Survival);DCR (Disease Control Rate);Overall survival (OS);DoR (Duration of Relief);Safety; | — |
Countries
China
Contacts
Public ContactLi Ning
Henan Cancer Hospital
Outcome results
None listed