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Mini Oral session 1: Gynaecological cancers

522MO - Preliminary results of sintilimab (Sin)+bevacizumab (Bev) in recurrent/persistent ovarian clear cell carcinoma (INOVA): A multicenter, single-arm, phase II trial


10 Sep 2022


Mini Oral session 1: Gynaecological cancers


Clinical Research;  Immunotherapy

Tumour Site

Ovarian Cancer


Qinglei Gao


Annals of Oncology (2022) 33 (suppl_7): S235-S282. 10.1016/annonc/annonc1054


X. Liu1, B. Xia2, W. Zhang3, L. Sun4, C. Feng5, Y. Huang6, Y. Gao7, J. Jiang8, G. Li9, Q. Gao1

Author affiliations

  • 1 Department Of Gynecologic Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 - Wuhan/CN
  • 2 Division Of Life Sciences And Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei/CN
  • 3 National Clinical Research Center For Obstetrics And Gynecology, Cancer Biology Research Center (key Laboratory Of The Ministry Of Education), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 - Wuhan/CN
  • 4 National Cancer Center/national Clinical Research Center For Cancer/ Department Of Gynecology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 5 Department Of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430030 - Wuhan/CN
  • 6 Department Of Gynecological Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430074 - Wuhan/CN
  • 7 Key Laboratory Of Carcinogenesis And Translational Research (ministry Of Education), Department Of Gynecologic Oncology, Peking University Cancer Hospital and Institute, 100142 - Beijing/CN
  • 8 Department Of Obstetrics And Gynecology, Qilu Hospital of Shandong University, 250012 - Jinan/CN
  • 9 Department Of Gynecological Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 - Wuhan/CN


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Abstract 522MO


Recurrent ovarian clear cell carcinoma (OCCC) has an abysmal prognosis with only 6∼8% ORR in chemotherapy. Antiangiogenic therapy and immunotherapy might have potential efficacy in OCCC due to the unique clinicopathological characteristics, gene expression profile, and immune microenvironment. Moreover, anti-PD-1 + Bev has shown certain efficacy in renal clear cell carcinoma, which exhibits similar gene expression profiles to OCCC. Herein, we aim to investigate the potential benefit of Sintilimab (PD-1 antibody) + Bev combination therapy for recurrent/persistent OCCC patients.


This INOVA study followed Simon's 2-stage design. A total of 38 recurrent/persistent OCCC patients with at least one-line pretreated platinum-containing chemotherapy were planned to be recruited. Patients receive Sin (200mg iv. q3w) and Bev (15mg/kg iv. q3w) until disease progression or intolerable toxicity, up to 2 year and 22 cycles, respectively. The primary endpoint was investigator evaluated objective response rate (ORR) per RECIST 1.1. If more than 1 of 17 patients achieved objective response in stage 1, the study will enter stage 2.


Between April 8, 2021 and April 25, 2022 (data cutoff), 23 patients had been enrolled, with median age of 58 (range,28-67) and 73.9% were Bev naive. All patients received prior platinum-containing chemotherapy. The median lines of treatment were 3 (range, 2-8). 18 of 22 patients (81.8%) were platinum-resistant relapsed. 20 patients were evaluable with at least one radiological evaluation after base line. 8 patients achieved objective response which inferred an ORR of 40.0% (1 CR, 7 PR; 95% CI, 19.1%-63.9%) and a DCR of 75.0% (8 OR, 7 SD; 95% CI, 50.9%-91.3%). Frequently occurring adverse events were grade 1-2, including proteinuria (33.3%), hypothyroidism (27.8%) and ALT, AST elevation (16.7%). Only one (5.6%) patient had a grade 3 immune myocarditis.


Sintilimab and bevacizumab combination therapy as a chemo-free regimen exhibites promising efficacy and favorable safety for recurrent/persistent OCCC patients. The trial is still recruiting, more data would be further analyzed and reported.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

The authors.


Beijing CSCO Clinical Oncology Research Foundation.


All authors have declared no conflicts of interest.

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