Fruquitinib Combined With Camrelizumab in Non MSI-H/dMMR Refractory Colorectal Cancer

This is an interventional treatment trial for Colorectal Neoplasm focused on measuring colorectal cancer, non MSI-H/dMMR, Camrelizumab, Fruquintinib Read More

Inclusion Criteria:

• Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
• Subjects with non MSI-H / dMMR metastatic colorectal cancer(CRC) (Stage IV)
• Subjects must have failed at least two lines of prior treatment, which must include a fluoropyrimidine, oxaliplatin and irinotecan.
• Subjects must not have been treated with Fruquitinib or any anti-PD-1 inhibitors.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.is necessary.
• Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.
• Assigned informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• Life expectancy of at least 3 months.
• Subjects must complete the treatment and follow-up on schedule according to the research plan.
• No brain metastasis, no spinal cord compression.
• Subjects agree to use blood samples for study analysis.
• Women of childbearing age must be negative in pregnancy test and willing to take effective contraceptive measures during the study period.

Exclusion Criteria:

• Subjects are severe malnutrition or need tube feeding.
• Radiotherapy or surgery has been performed within 30 days before treatment.
• Previous treatment with anti-PD-1 / PD-L1 inhibitor and / or fruquitinib.
• Other malignant tumors within 2 years and without cure (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix);
• Subjects have active autoimmune system diseases、systemic hormone therapy or anti autoimmune drug therapy.
• Subjects with immunodeficiency or receiving systemic steroid therapy (prednisone > 10 mg / day or other equivalent drugs) or other forms of immunosuppressive therapy 7 days before the first dose of combination therapy in this study;
• Subjects with active infection and still need systemic treatment 7 days before the first dose of therapy in this study.
• Subjects with uncontrollable systemic diabetes.
• Subjects with interstitial lung disease, non infectious pneumonia or pulmonary fibrosis;
• Subjects who have received allogeneic organ or stem cell transplantation in the past.
• Subjects allergic to the drugs or related components involved in this study.
• Are participating in other interventional clinical studies.
• The previous anti-tumor related adverses do not return to grade 1 in CTCAE before the first combination therapy.
• Subjects who have uncontrolled hypertension by drugs, that is, systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg.
• Thrombotic or hemorrhagic tendency or history within 60 days before the first medication, regardless of the severity.
• Any serious or unstable medical condition、mental illness or known active alcohol or drug abuse or dependence.