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TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Clinical Trial Summary

This is a phase II clinical trial to evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab in patients with recurrent/metastatic nasopharyngeal carcinoma. This study is divided into two parts. The first part includes the safe introduction phase and the expansion phase. The second part is a randomized controlled study design, which is divided into two groups. The two parts of research are carried out at the same time

Clinical Trial Description

This study is divided into two parts: The first part includes the safe introduction phase and the expansion phase. All the patients with advanced nasopharyngeal carcinoma who failed to be treated with platinum chemotherapy and immunocheckpoint inhibitors (anti-PD-1 monoclonal antibody/anti-PD-L1 monoclonal antibody, etc.) were enrolled. The treatment scheme is TQB2618 + Penpulimab Injection. During the safe introduction period, we explored whether the two dose groups (1200mg/1500mg) were safe and tolerable when TQB2618 was combined with Penpulimab Injection. If the two dose groups are tolerable, 18~24 patients in the second phase of the extended study were randomized to receive TQB2618 in two dose groups (1200mg/1500mg)+Penpulimab Injection (200mg) at a ratio of 1:1. If high dose (1500mg) of TQB2618 is not tolerated, all patients will receive TQB2618 (1200mg)+Penpulimab Injection (200mg). The second part is a randomized controlled study design, which is divided into two groups. All the newly treated patients with advanced nasopharyngeal carcinoma who have not received systematic treatment in the past received TQB2618+Penpulimab Injection+GP chemotherapy and paianzulimab+GP chemotherapy respectively. The dose of TQB2618 was 1200mg. The two parts of research are carried out at the same time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05563480
Study type Interventional
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Jun Ma, Doctor
Phone +86 13078892696
Email majun@sysucc.org.cn
Status Recruiting
Phase Phase 2
Start date October 27, 2022
Completion date May 2024
View Details
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