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

Cervical Cancer Clinical Trial

Official title:
Effect of Compound Kushen Injection Combined With Pabolizumab in the Treatment of Cervical Adenocarcinoma: A Phase II Single-arm Clinical Study

Clinical Trial 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.

Clinical Trial Description

In this study, PD-1 inhibitors (pabolizumab) combined with compound kushen injection were used to treat metastatic, recurrent, persistent cervical adenocarcinoma, and the efficacy and safety of the two drugs were evaluated. Participants who meet the requirements will sign the informed consent and be enrolled voluntarily. This project is a single-arm study without a control group. Forty-two patients are expected to be enrolled. Two scoring systems, the combined positive score (CPS) and the tumor proportion score (TPS), are used for evaluation of PD-L1 expression of solid tumors. Through the measurable changes in the size of the lesions, the investigators can understand the changes of the disease. The primary endpoints were PFS and ORR. Whenever, for whatever reason, the subject does not complete the clinical trial observation, is considered to be an abscission case. When the subject falls off, the investigators must fill in the reason for the fall off in the CRF, and contact the subject as much as possible, complete the items that can be evaluated, and record the time of the last medication to prepare for the analysis of its efficacy and safety. The CRF should be kept for future reference. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05259540
Study type Interventional
Source Women's Hospital School Of Medicine Zhejiang University
Contact Lili Chen, MD
Phone 8657187061501
Email 5197004@zju.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date January 1, 2023
Completion date December 31, 2025
View Details
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