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Fruquintinib or regorafenib (Tyrosine Kinase Inhibitor (TKI)) in combination with anti-PD-1 antibody. The TKI is determined according to response.

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Inclusion Criteria

Inclusion Criteria:

Subjects who voluntarily participated in the study, signed the written informed consent form, and could comply with the protocol of study.
Male or female of age 18-75 years.
Subjects with colorectal adenocarcinoma who were histopathologically confirmed, and with locally advanced (unresectable) or mCRC.
Subjects who underwent standard antitumor therapies (fluorouracil, oxaliplatin, irinotecan were used, with or without administration of bevacizumab and/or cetuximab).
Patients with MSS/pMMR mCRC (immunohistochemistry, polymerase chain reaction or next-generation sequencing can be used).
All adverse reactions associated with drug use or surgery were reduced to grade 0-1 (according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0) or to a level required by the protocol criteria.
The presence of at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
Subjects with life expectancy ≥ 12 weeks.
Adequate important organs functions: bone marrow function (neutrophil count ≥ 1.5×10^9/L; platelet ≥ 80×10^9/L; hemoglobin ≥ 90 g/L), liver function (serum albumin ≥ 28 g/L; total bilirubin ≤ 1.5×upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤ 3×ULN, or ≤ 5×ULN if liver metastases are present), renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance (CrCl) ≥ 40 mL/min, using the Cockcroft-Gault formula; urine protein < 2+; 24h urinary protein content < 1.0 g/24h if urinary protein ≥ 2+ ), coagulation function (international normalized ratio or activated partial thromboplastin time ≤ 2×ULN), thyroid function (thyrotropin ≤ 1×ULN).

Exclusion Criteria

Exclusion Criteria:

Known microsatellite instability high (MSI-H) mCRC.
Participation in another study with intervention or drugs within the past 4 weeks.
Performing surgery and incomplete recovery within the past 4 weeks.
Subjects with active autoimmune diseases or with related history. Subjects with controlled type I diabetes or hypothyroidism with substitution therapy may be included for further screening.
Any conditions requiring corticosteroids (> 10 mg per day of prednisone or equivalent) or immunosuppressive drugs as systemic treatment within the past 1 week.
Other active malignancy within the past 5 years, except for the cured limited cancer (such as basal cell carcinoma, carcinoma in situ of the prostate or cervix, etc.).
Subjects with history of hepatic encephalopathy or confirmed metastases to central nervous system.
Subjects with non-infectious pneumonia under steroid treatment within the past 6 months.
Suffering from chronic or active infections, fever (≥ 38.5℃) within the past 1 week, or white blood cell count > 15×10^9/L), requiring systemic anti-infective treatment at the screening period, except for viral hepatitis.
Subjects with any other abnormal condition that is inconsistent with the study medication, or may increase the risk of the subject，according to investigators' judgment.
Congenital or acquired immunodeficiency (such as human immunodeficiency virus).
Subjects with active hepatitis B virus (HBV) (HBV surface antigen positive and HBV-DNA > 2000 IU/ml) or hepatitis C virus (HCV) (HCV antibody and HCV-RNA positive).
Subject who received a live attenuated vaccine within the past 4 weeks, or vaccination is planned during anti-PD-1 antibody treatment or within 5 months after the last treatment.
More than mild pericardial effusion, massive pleural or/and peritoneal effusions need puncture and drainage at the screening period.
Subjects with symptomatic heart and cerebrovascular diseases: heart failure (New York Heart Association class III or IV, left ventricular ejection fraction < 50%), uncontrolled hypertension or arrhythmias, serious cardiovascular and cerebrovascular events (acute coronary syndrome, stroke, thromboembolism, etc.) within the past 6 months.
Known allergy to targeted drugs.
Women being pregnant, or during lactation, or planning to get pregnant during the trial.
Subjects with any other conditions judged by investigators would be excluded.