5586 Background: Ovarian clear cell carcinoma (OCCC) is a histologically aggressive subtype of epithelial ovarian cancer with limited effective treatment options, particularly for recurrent disease. This study aims to evaluate the efficacy and safety of surufatinib (a kinase inhibitor targeting VEGFR 1, 2, 3, FGFR 1, and CSF-1R) in combination with toripalimab (an anti PD-1 antibody) for recurrent OCCC. Here, we present the latest efficacy and safety data. Methods: 23 patients aged 18-75 with histologically confirmed recurrent OCCC, ECOG performance status of 0-2, and failed first or subsequent-line therapy was enrolled (If the patient only had first line chemotherapy, platinum-free interval should be less than 12 months or disease progression occurred during chemotherapy). Patients received orally surufatinib 250 mg once daily in combination with toripalimab 240 mg on day 1 every 3 weeks until disease progression or unacceptable toxicity. Primary endpoint is progression-free survival (PFS), and secondary endpoints include objective response rate (ORR), overall survival (OS), and safety. Results: From Jul. 2023 to Dec. 2025, 19 patients (median age 51) were enrolled, with 52.6% (10/19) had an ECOG PS of 0, 73.7% (14/19) were classified as clinical stage of I-II. 57.9% (11/19) had received prior first-line treatment, while the remaining 8 patients had received twice or more. Eight patients had previously received bevacizumab. Among the 19 patients, 10 were platinum-resistant while 9 were platinum-sensitive. The primary metastatic sites were lymph nodes (8/19, 42.1%), lungs (6/19, 31.6%), pelvic cavity (6/19, 31.6%) and peritoneum (5/19, 26.3%). With a median follow-up of 7.1 months, the median PFS was 4.4 months (95% CI: 2.6-8.8). Tumor response was evaluable in 19 patients, with 1 complete response, 4 partial response and 11 had stable disease, resulting in an ORR of 26.3% (95% CI: 9.2-51.2%), and a disease control rate of 84.2% (95% CI: 60.4-96.6%). The most common (≥20%) treatment related adverse events (TRAEs) were hyperthyroidism (42.1%), proteinuria (36.8%), hypertension (36.8%), diarrhea (36.8%), anaemia (31.6%), rash (31.6%), increased TSH (26.3%), hypoalbuminaemia (21.1%), increased AST (21.1%) and increased ALT (21.1%). Grade 3 TRAEs (≥10%) were mainly hypertension (15.8%), increased AST (15.8%), increased ALT (10.5%). All of AEs were effectively controlled after temporarily discontinuing surufatinib or toripalimab, or reducing the dose of surufatinib, or receiving symptomatic treatment. There were no cases with fatal outcome. Conclusions: The combination of surufatinib and toripalimab exhibited potential clinical activity and tolerable toxicity in patients with recurrent OCCC. Clinical trial information: ChiCTR2400083672.
Yang et al. (Wed,) studied this question.