Cancer Biology Research Center (Key Laboratory of the Ministry of Education), Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Department of Gynecological Oncology, Wuhan Union Hospital, Wuhan, Hubei, China.
BMJ Open. 2022 May 24;12(5):e058132. doi: 10.1136/bmjopen-2021-058132.
Ovarian clear cell carcinoma (OCCC) has an abysmal prognosis with a median overall survival (OS) of 25.3 months because of a low response to chemotherapy. The 5-year disease-specific survival rate after recurrence is 13.2%, with more than two-thirds of the patients dying within a year. Therefore, it is urgent to explore new therapeutic options for OCCC. Based on the characteristic immune-suppressive tumour microenvironment derived from the gene expression profile of OCCC, the combination of immunoantiangiogenesis therapy might have certain efficacy in recurrent/persistent OCCC. This trial aims to evaluate the efficacy and safety of sintilimab and bevacizumab in patients who have failed platinum-containing chemotherapy with recurrent or persistent OCCC.
In this multicentre, single-arm, open-label, investigator-initiated clinical trial, 38 patients will be assigned to receive sintilimab 200 mg plus bevacizumab 15 mg/kg every 3 weeks. The eligibility criteria include histologically diagnosed patients with recurrent or persistent OCCC who have been previously treated with at least one-line platinum-containing chemotherapy; patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with an expected survival greater than 12 weeks. The exclusion criteria include patients previously treated with immune checkpoint inhibitor and patients with contraindications of bevacizumab and sintilimab. The primary endpoint is the objective response rate. The secondary endpoints are progression-free survival, time to response, duration of response, disease control rate, OS, safety and quality of life. Statistical significance was defined as p<0.05.
This trial was approved by the Research Ethics Commission of Tongji Medical College of Huazhong University of Science and Technology (2020-S337). The protocol of this study is registered at www.
gov. The trial results will be published in peer-reviewed journals and at conferences.
NCT04735861; Clinicaltrials. gov.
由于对化疗的反应较低，卵巢透明细胞癌（OCCC）的预后极差，中位总生存期（OS）为 25.3 个月。复发后 5 年疾病特异性生存率为 13.2%，超过三分之二的患者在一年内死亡。因此，迫切需要为 OCCC 探索新的治疗选择。基于 OCCC 基因表达谱得出的特征性免疫抑制肿瘤微环境，免疫抗血管生成治疗联合可能对复发性/持续性 OCCC 具有一定疗效。本试验旨在评估信迪利单抗联合贝伐珠单抗在铂类化疗失败的复发性或持续性 OCCC 患者中的疗效和安全性。
这是一项多中心、单臂、开放标签、研究者发起的临床试验，将 38 例患者分配接受信迪利单抗 200mg 联合贝伐珠单抗 15mg/kg，每 3 周 1 次。纳入标准包括组织学诊断为复发性或持续性 OCCC 患者，既往接受过至少一线含铂化疗；ECOG 体能状态 0-2 分，预期生存时间超过 12 周。排除标准包括既往接受过免疫检查点抑制剂治疗的患者和贝伐珠单抗和信迪利单抗禁忌证的患者。主要终点是客观缓解率。次要终点包括无进展生存期、反应时间、缓解持续时间、疾病控制率、OS、安全性和生活质量。有统计学意义的定义为 p<0.05。
该试验已获得华中科技大学同济医学院伦理委员会批准（2020-S337）。本研究方案在 www.clinicaltrials.gov 注册。
NCT04735861；Clinicaltrials.gov。
NCT04735861；Clinicaltrials.gov。
