Neoadjuvant Safety of Sintilimab + XELOX + Bevacizumab in PMMR/MSS CRLM Patients (NCT04940546) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Neoadjuvant Safety of Sintilimab + XELOX + Bevacizumab in PMMR/MSS CRLM Patients
China36 participantsStarted 2021-06-16
Plain-language summary
This prospective, single arm study aims to evaluate the preoperative neoadjuvant safety of Sintilimab combined with XELOX plus bevacizumab in colorectal patients with liver metastasis and pMMR/MSS status.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Age ≥18 years old and ≤75 years old
* Histologically confirmed colorectal adenocarcinoma
* Radiologically and/or pathologically confirmed liver metastasis
* Immunohistochemistry and/or genetic testing confirmed pMMR/MSS
* Absence of extrahepatic metastasis confirmed by CT, MRI or PET/CT (if necessary)
* Primary lesion has been or can be removed by radical surgery
* Liver metastases can be resected (or using intraoperative radiofrequency) and is expected to achieve tumor-free status (NED) after surgery. Resectable liver metastases are defined explicitly as ①less than 5 metastatic lesions; ② R0 resection is achievable by resection or intraoperative radiofrequency; ③ Remaining liver volume is expected to be sufficient after surgery; ④ The following can be retained after resection: One hepatic vein, preserve blood flow in and out of the remaining liver, the bile duct, and at least 2 adjacent livers segments ⑤ There is no extrahepatic metastasis.
* Apart from surgical resection of the primary lesion, he/she has not received any anti-tumor treatment for liver metastasis (including chemotherapy, targeted drugs, interventional therapy, immunotherapy, radiotherapy, etc.)
* Normal hematological function (platelets\>90×109/L; white blood cells\>3×109/L; neutrophils\>1.5×109/L)
* Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), transaminase ≤ 5 times ULN, alkaline phosphatase ≤2.5 ULN, No ascites, normal coagulation function, albumin ≥35g/L
* Child-Pug…