Unresectable metastatic colorectal cancer with wild-type RAS/BRAF
Conditions
Interventions
Intervention group:The patient will receive 8 cycles of Cetuximab ß injection combined with the FOLFIRI regimen for induction therapy, followed by maintenance therapy with Cetuximab ß injection combin
Sponsors
Zhongshan Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participates in this study, has good compliance, is able to cooperate with the trial requirements to complete observations and follow-ups, and has signed the informed consent form. 2. Aged >=18 years at the time of signing the informed consent form. 3. Histologically confirmed diagnosis of colon or rectal adenocarcinoma. 4. Presence of metastatic lesions (not amenable to radical resection). 5. Genetically confirmed wild-type RAS/BRAF genes. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1. 7. Estimated survival time >=12 weeks. 8. Has recovered from relevant toxicities of prior therapy before study enrollment. 9. At least one measurable lesion meeting the RECIST 1.1 criteria (outside the radiation field) confirmed by CT or MRI. 10. Fertile subjects must use appropriate contraceptive methods during the study period and within 120 days after study completion, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1.Received radiotherapy or surgery within 30 days prior to initiation of treatment (excluding previous diagnostic biopsies); 2.Organ function meets any of the following criteria: Bone marrow: White blood cell (WBC) count 1.5 × upper limit of normal reference range; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 × upper limit of normal reference range (for patients without liver metastasis) or > 5 × upper limit of normal reference range (for patients with liver metastasis); Kidney: Serum creatinine (Cr) > 1.5 × upper limit of normal reference range or creatinine clearance 10³ copies/mL); 18.Pregnancy or lactation; 19.Subjects with known alcohol or drug addiction, or other poor medical or psychiatric conditions that, in the investigator’s judgment, may affect protocol compliance and assessment of trial endpoints and render the subject ineligible for study participation; 20.Lack of legal capacity or limited legal capacity;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum exosomes; | — |
Countries
China
Contacts
Public ContactLi Xiao
Zhongshan Hospital Affiliated to Xiamen University
Outcome results
None listed