Effect of Compound Kushen Injection Combined With Pabolizumab in the Treatment of Cervical Adenocarcinoma

Summary

In the past few decades, the incidence of endocervical adenocarcinomas (ECAs) has been on the rise both in absolute numbers and overall proportion in cervical cancers. ECAs remain a significant public health problem despite advances in treatment options. Patients with ECA have a poorer survival rate than patients with squamous cell carcinoma (SCC), especially in patients with metastatic tumors. In the newly published 2020 World Health Organization (WHO) Classification of Female Genital Tumors, ECAs are subclassified into human papillomavirus-associated (HPVA) and human papillomavirus-independent (HPVI) groups. Meanwhile, PD-1/PD-L1 immunotherapy has been approved for the treatment of advanced cervical cancer, but there are still many deficiencies. Therefore, the investigators plan to use the new classification of female genital tumors and conduct a clinical trial to explore the safety and effectiveness of compound kushen injection combined with pabolizumab in the treatment of metastatic, recurrent, persistent cervical adenocarcinoma.

Timeline

Start

2023-01-01

Primary completion

2025-12-31

Completion

2025-12-31

Publications

• Background Chen L, Niu Y, Wan X, Yu L, Zhang X, Strickland AL, Dong L, Zhou F, Lu W. Clinicopathological features and outcomes in gastric-type of HPV-independent endocervical adenocarcinomas. BMC Cancer. 2021 Oct 11;21(1):1095. doi: 10.1186/s12885-021-08792-7.
• Background Chen L, Lucas E, Zhang X, Liu Q, Zhuang Y, Lin W, Chen H, Zhou F. Programmed death-ligand 1 expression in human papillomavirus-independent cervical adenocarcinoma and its prognostic significance. Histopathology. 2022 Jan;80(2):338-347. doi: 10.1111/his.14552. Epub 2021 Oct 13.
• Background Frenel JS, Le Tourneau C, O'Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A. Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. doi: 10.1200/JCO.2017.74.5471. Epub 2017 Nov 2.
• Background Chung HC, Ros W, Delord JP, Perets R, Italiano A, Shapira-Frommer R, Manzuk L, Piha-Paul SA, Xu L, Zeigenfuss S, Pruitt SK, Leary A. Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2019 Jun 10;37(17):1470-1478. doi: 10.1200/JCO.18.01265. Epub 2019 Apr 3.

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