564P Efficacy and safety of tislelizumab plus anlotinib in the treatment of cervical cancer resistant to standard therapy: A prospective, single-arm, open labelled phase II clinical trial

There is limited treatment options for patients with metastatic or recurrent cervical cancer who progressed after standard first-line chemotherapy. Recently, immune checkpoint inhibitor (ICI) therapy has been approved as a second-line treatment for patients with advanced cervical cancer. However, only a small subset of patients responds to ICI therapy. ICI therapy combined with anti-angiogenic drugs may enhance cancer immunity and is a promising option for advanced cervical cancer. In this open-label phase II study, a total 32 patients will be enrolled. All patients are given the intravenous infusion of tislelizumab 200 mg d1 and oral anlotinib 10 mg qd for 14 days every 3 weeks until disease progression or intolerable toxicity. The primary end point was investigator-confirmed objective response rate (ORR) per IRECIST v1.1. The secondary endpoints are disease control rate (DCR), duration of remission (DOR), median progression-free survival (PFS), median overall survival (OS), safety and tolerability. Until 31st March, 2022，seventeen patients have received at least four cycles of treatment. The ORR was 35.3% (95% CI, 17.3 to 58.7), the DCR was 94.1%(95%CI,73.0 to 98.9). The median PFS and OS was not reached. Furthermore, all patients experienced treatment-related adverse events (TRAEs). The most frequent TRAEs were hypertension (18.1%), Hand-foot syndrome (12.9%), and abdominal pain(9.3%). Grade ≥3 TRAEs occurred very rarely（0.06%）. Available evidence showed that tislelizumab plus anlotinib had therapeutic efficacy and good tolerability in the treatment of advanced cervical cancer. No overlapping toxicity has been observed. Further results are expected.