| Eligibility |
Inclusion Criteria:
1. Age ranged from 18 to 75 years old (inclusive), regardless of gender;
2. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF
wild-type and non-dMMR/MSI-H;
3. Tumor tissue available for central laboratory testing;
4. Metastatic colorectal cancer with disease progression after 2nd line treatment;
previously received standard chemotherapy based on fluorouracil, oxaliplatin,
irinotecan; patients are allowed to previously receive EGFR and/or VEGF inhibitors,
but not allowed to previously receive regorafenib, fruquintinib, or TAS-102;
5. Measurable disease according to RECIST1.1;
6. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
7. Life expectancy =3 months
8. Adequate main organs and bone marrow function.
9. Patients must give informed consent to this study before the experiment and
voluntarily sign a written informed consent form.
Exclusion Criteria:
1. Previously used anti PD-1, anti PD-L1, anti CTLA-4, or cellular immunotherapy;
2. Central nervous system metastasis or meningeal metastasis;
3. Patients with high risk of bleeding due to tumor invasion of important arteries;
4. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion,
or abdominal effusion;
5. Patients who require continuous use of morphine-based drugs to control pain;
6. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have
not yet recovered to CTCAE 5.0 evaluation = level 1;
7. Diagnosed as a second primary malignant tumor within 5 years prior to the first
administration of the study drug;
8. Have received anti-tumor treatments such as chemotherapy, biological therapy, targeted
therapy, etc. within 21 days before the first dose of the study drug; radiotherapy
within 2 weeks before the first dose of the study drug; Chinese medicine or Chinese
patent medicine with anti-tumor effect within 1 week before the first dose of the
study drug;
9. Have received a live viral vaccine or live-attenuated vaccine within 28 days before
the first dose of study drug or plan to receive it during the study;
10. Use of immunosuppressive medications within 14 days prior to the first dose of study
drug;
11. Those who use strong CYP3A4 inducers within 14 days before the first administration of
the study drug, or those who use strong CYP3A4 inhibitors or strong UGT1A1 inhibitors
within 1 week, or those who cannot suspend the use of the above drugs during the
study;
12. Have received radiation therapy or other localized palliative treatment within 14 days
before the first dose of study drug;
13. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic
injury within 28 days before the first dose of study drug;
14. Have a history of serious cardiovascular disease;
15. Previous or current presence of interstitial pneumonia/lung disease;
16. History of autoimmune diseases;
17. A history of immunodeficiency, including HIV testing positive, or having other
acquired or congenital immunodeficiency diseases, or having a history of organ
transplantation;
18. Have infectious diseases requiring systemic anti-infective treatment;
19. Active hepatitis B; hepatitis C infection; syphilis infection, active tuberculosis;
20. Known presence of hypersensitivity or intolerance to any component of EGFR monoclonal
antibody, PD-1 monoclonal antibody, irinotecan hydrochloride injection, regorafenib
and its excipients;
21. Women during lactation or pregnancy; women with fertility tested positive for blood
pregnancy within 7 days prior to enrollment in the trial;
22. Any male and female patients with fertility who refuse to use effective contraceptive
methods throughout the entire trial period and within six months after the last
administration;
23. Other conditions that, in the opinion of the investigator, may affect the safety or
compliance of drug treatment in this study, including but not limited to: psychiatric
disorders, any severe or uncontrollable diseases, etc.
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