The purpose of this study is to evaluate the efficacy and safety of fruquintinib or regorafenib in combination with anti-PD-1 antibody in TKI (fruquintinib or regorafenib)-responded MSS/pMMR metastatic colorectal adenocarcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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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,…
What they're measuring
1
9-month progression-free survival (PFS) rate (in subjects receiving TKI followed by TKI in combination with anti-PD-1 antibody)