To observe the clinical efficacy and safety of trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules in advanced colorectal cancer patients after progression in second-line treatment.

Advanced colorectal cancer patients who had progression after second-line treatment were divided into the control group and the treatment group according to the treatment methods. The control group received tislelizumab injection 200 mg combined with fruquintinib capsules 5 mg, and the treatment group received 25 mg·m² trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules. A 21-day period was considered as one cycle, and both groups were treated continuously for 3 cycles. Clinical efficacy, tumor marker levels, angiogenesis factor levels, safety evaluation and survival were compared between the two groups.

This study enrolled 86 patients in total. The control group consisted of 45 patients, while the treatment group had 41 patients. After treatment, the disease control rates of the control group and the treatment group were 48.89% (22 cases/45 cases) and 73.17% (30 cases/41 cases), respectively; the levels of carbohydrate antigen 125 were (51.97±6.49) and (48.17±4.55) U·mL^-1, respectively; the levels of cytokeratin 19 fragment antigen 21-1 were (24.41±4.54) and (21.53±3.56) μg·L^-1, respectively; the levels of carcinoembryonic antigen were (30.84±6.42) and (27.76±4.44) ng·mL^-1, respectively; the levels of vascular endothelial growth factor (VEGF) were (97.82±16.74) and (90.29±16.74) pg·mL^-1, respectively; the levels of angiopoietin (Ang)-1 were (11 829.14±1 367.27) and (12 612.20±1 889.47) pg·mL^-1, respectively; the levels of Ang-2 were (486.90±113.66) and (430.59±76.93) pg·mL^-1, respectively; the levels of interleukin (IL)-8 were (10.54±2.39) and (9.05±1.85) pg·mL^-1, respectively; and the median progression free survival periods were 11 and 16 months, respectively. The above indicators of the treatment group were statistically significant different compared with the control group (all P<0.05). The main adverse drug reactions in the treatment group and the control group were nausea and vomiting, leukopenia, anemia, thrombocytopenia, hematochezia, elevated alanine aminotransferase, hand-foot syndrome, hypothyroidism, oral mucositis, hypertension and proteinuria. There was no statistically significant difference in the incidence of adverse drug reactions between the treatment group and the control group (P>0.05).

Trifluridine-tipiracil hydrochloride tablets combined with tislelizumab injection and fruquintinib capsules can significantly improve the clinical efficacy in patients with advanced colorectal cancer who progressed after second-line treatment, prolong progression-free survival, reduce angiogenesis factor levels, and have a certain degree of safety.