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EV344/#770  Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: a prospective single center, single-arm phase II clinical trial
  1. Shuang Ye,
  2. Yi Fu,
  3. Shuai Liu,
  4. Jun Wang,
  5. Lin Zhou,
  6. Wei Jiang,
  7. Xuan Pei,
  8. Wenbin Shen,
  9. Min Sun,
  10. Boer Shan and
  11. Huijuan Yang
  1. Fudan University Shanghai Cancer Center, Shanghai, China

Abstract

Introduction Ovarian clear cell carcinoma (OCCC) is a histologically aggressive subtype of epithelial ovarian cancer with limited effective treatment options, particularly for patients with 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) combined with toripalimab (an anti PD-1 antibody) for recurrent OCCC.

Methods 23 histologically confirmed recurrent OCCC patients, aged 18-75, with an ECOG PS of 0-2 will be enrolled. They should have failed first or subsequent-line therapy. Patients will receive surufatinib 250mg once daily in combination with toripalimab (240mg, day 1, q3w) until disease progression or unacceptable toxicity. Primary endpoint is progression free survival (PFS), and secondary endpoints include objective response rate (ORR), overall survival (OS), adverse event (AE), etc.

Results From Jul, 2023, to Mar, 2024, 9 patients were enrolled. The characteristic was shown in table 1. The median age was 50 years (range 44-63). 89% patients had received prior first-line treatment. Four patients had previously received bevacizumab therapy. 6 patients were evaluable. 2 patients achieved PR, and 2 SD, yielding an ORR of 33.3%, DCR of 66.7%(table 2). The median PFS was not reached. The most common treatment related AEs (TRAEs) were anaemia (66.7%), proteinuria (44.4%), hematuresis (44.4%), and hypertension (44.4%), increased TSH (thyroid stimulating hormone, 44.4%) and most of TRAEs were grade 1/2 except one patient experienced grade 3 transient hypertension.

Conclusion/Implications The combination of surufatinib and toripalimab has shown a potential clinical activity and tolerable toxicity in patients with recurrent OCCC.

Abstract EV344/#770 Table 1
Abstract EV344/#770 Table 2

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