Cadonilimab (AK104) in the Treatment of Nasopharyngeal Carcinoma

Status Recruiting

Clinical Trial Summary

This study is a phase II clinical study of Cadonilimab (AK104) combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma.

Clinical Trial Description

The purpose is to evaluate the safety and effectiveness of Cadonilimab combined with chemotherapy in the treatment of PD-1 inhibitor-resistant nasopharyngeal carcinoma as the second line and above. This study is a single-arm, phase II clinical study. It is planned to enroll about 30 patients with PD-1 inhibitor resistant nasopharyngeal carcinoma. PD-Ll CPS (<50% vs>50%, subjects whose PD-Ll expression could not be evaluated were classified as<50%) was used as the stratification factor. The study will set up a safety induction period. It is planned to enroll about 6 PD-1 inhibitor resistant subjects first, and the researchers will conduct a preliminary safety assessment. If the safety and tolerability are good, and the preliminary curative effect signal is observed, it will enter the extended group period. When about 15 subjects are selected, effectiveness analysis will be carried out. If 6 of the 15 subjects with severe side effects can not tolerate, the researcher may stop the group of subjects after discussion. In case of poor safety, the researcher decided to revise or stop the study after discussion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05790200
Study type	Interventional
Source	Wuhan Union Hospital, China
Contact	Yang Kunyu, Doctor
Phone	13995595360
Email	yangkunyu@hust.edu.cn
Status	Recruiting
Phase	Phase 2
Start date	April 1, 2023
Completion date	September 22, 2025

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