Colorectal Cancer
Conditions
Interventions
Test group:Cetuximab + Sindilizumab + Raltitrexed
Sponsors
Anhui Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with pathologically confirmed advanced adenocarcinoma of the colon or rectum; initial tissue RAS/BRAF wild type. 2) treated with at least and only 2 standard regimens after recurrence or metastasis; received cetuximab in combination with chemotherapy in first line and produced at least partial remission with a first-line PFS of 6 months or more. RAS, BRAF and EGFR outer domain wild-type status on peripheral blood ctDNA screening after progression to the last anti-EGFR-free regimen; 3) Presence of at least one measurable lesion (non-radiotherapy field) meeting RECIST 1.1 criteria, confirmed by CT or MRI. 4) Male or female, age 18 to 75 years (including borderline values). 5) Patients with Eastern Cooperative Oncology Group (ECOG) score physical status of 0 or 1. 6) Expected survival of at least 3 months and a place of residence that facilitates follow-up. 7) Subjects with measurable lesions (at least 1 extracranial lesion) according to the solid tumor evaluation criteria (RECIST v1.1). (8) Patients with asymptomatic central nervous system (CNS) metastases or treated asymptomatic brain metastases must be free of disease by computed tomography (CT) or magnetic resonance imaging (MRI) progression, stable for at least 3 months, and not requiring steroid medication for at least 4 weeks. 9) Laboratory test results within two weeks prior to enrollment that meet the following criteria. Absolute neutrophil count (ANC) >= 1.5*109/L. absolute white blood cell count (WBC) >= 3.0*10^9/L. Platelets >= 100*109/L. Hemoglobin >= 90 g/L. Serum creatinine <= 1.5 times the upper limit of normal (ULN). AST and ALT <= 2.5 times ULN and <= 5 times ULN in patients with liver metastases. serum total bilirubin (TBIL) <= 1.5 times ULN. International normalized ratio (INR) <= 2 times ULN, or <= 1.5 times ULN with activated partial thromboplastin (APPT) (except for patients on anticoagulant therapy) 10) Voluntary signed informed consent, understanding of the study and willingness to follow and ability to complete all trial procedures. 11) Male subjects and female subjects of childbearing age should agree to use effective contraception from the time they sign the informed consent until 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1) Those who had other malignant tumors within 5 years before enrollment, except cured cervical carcinoma in situ and healed basal skin cancer cell carcinoma. 2) Failure to recover from adverse effects of previous treatment to a CTCAE v5.0 grade score 10 mg prednisone/day) or other immunosuppressive drugs within 14 days prior to the first dose or during the study period 7) Patients with active peptic ulcers, incomplete intestinal obstruction, active bleeding or perforation of the gastrointestinal tract. 8) existing interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, radiation pneumonia 9) systemic diseases not controlled and stabilized by treatment, such as cardiovascular diseases, diabetes, hypertension tuberculosis, etc. 10) history of infection with human immunodeficiency virus, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or stem cell transplantation (11) Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B carriers, hepatitis B stabilized by drug therapy (DNA titer must not be higher than 500 IU/mL or copy number grade 3). (13) Participated in another drug clinical trial within 4 weeks prior to the first dose (based on the use of the test drug) 14) Alcohol-dependent persons or a history of drug or substance abuse within the last 1 year (15) Previous history of definite neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance, or the presence of peripheral nervous system disorders. 16) Those with symptomatic brain metastases. 17) Women who are pregnant or breastfeeding. 18) Subjects who, in the opinion of the investigator, are unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHe Yifu
Anhui Cancer Hospital
Outcome results
None listed