Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence: A Randomized Controlled Phase II Trial
This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.
• age ≥ 18 years old, female and male
• pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)
• Metastatic liver lesions \<= 5
• Primary colorectal cancer under control
• Absence of evidence of extra-hepatic diseases
• Metastatic liver lesions received resection with insufficient margin (\<0.5cm) or R1/R2 resection
• Karnofsky \>= 70
• Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy
• Without previous antitumoral immunotherapy
⁃ With good compliance
⁃ Signed the inform consent