132P Efficacy and safety of tislelizumab plus surufatinib in later-line treatment of metastatic colorectal cancer: A single-arm, phase ii trial with a negative result

Methods: Thirty patients with mCRC were expected to be enrolled.All the patients had received second-or later-line treatment for mCRC and had at least 1 measurable lesion per RECIST version 1.1.SBRT would be conducted as appropriate.One week later, fruquintinib would be administered with an oral daily dose of 3-5 mg on days 1-14 in combination with sintilimab 200 mg intravenously once for day 1 using a 21-day cycle.The treatment would continue until progressive disease or intolerable toxicity.The primary endpoint was PFS.Results: To date, 30 patients had been enrolled, of whom 19 patients were male.The median age was 61 (range: 32-77) years.With a median follow-up of 18.06 months, all pts underwent post-baseline tumor assessment once at least.Two (6.67%) patients achieved partial response, twelve (85.71%) patients kept stable disease.The objective response rate was 6.67% and the disease control rate was 96.67%.Median PFS and Median OS were 5.8 months and 18.8 months, while the 6-month PFS rate were 50%, 9-month PFS rate were 36.67%,12-month OS rate were 63.33%,18-month OS rate were 26.67%.Any grade TRAEs included fatigue (56.7%), hypoalbuminemia (50%), hypertension (36.7%),Platelet count decreased (36.7%),Pneumonia (30%).Grade 3/4 TEAEs were mainly Pneumoni(n=2), fatigue(n=1), Hypoalbuminemia (n=1).Conclusions: SBRT followed by fruquintinib in combination with immunotherapy yielded a promising efficacy and acceptable safety as third-and later-line treatment in mCRC, which warrants further large-scale studies.Clinical trial identification: ChiCTR2300071037.