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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06429397
Other study ID # 2023-FXY-304
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 15, 2024
Est. completion date May 28, 2026

Study information

Verified date May 2024
Source Sun Yat-sen University
Contact Fangjian Zhou, Doctor
Phone 13922735659
Email zhoufj@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is currently no standard first-line treatment for stage PPGL, and the 5-year survival rate of patients with advanced pheochromocytoma/paraganglioma (PPGL) is low, ranging from 30% to 60%. At present, several domestic teams have carried out clinical studies on the treatment of advanced PPGL with good efficacy. In the early stage, our center used anrotinib to treat advanced PPGL, and the overall effective rate reached 44%. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat advanced PPGL patients. The effective rate reached 66% (2/3). Therefore, the investigators plan to further conduct prospective studies to explore the efficacy and safety of anlotinib combined with PD-1 monoclonal antibody in the treatment of advanced PPGL, so as to bring benefits to patients with advanced PPGL.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Anlotinib and Penpulimab
Enrolled patients received a treatment cycle every 21 days: 200mg of piamprizumab was given intravenously on the first day of treatment, and 12mg of anrotinib hydrochloride capsule was given continuously for 14 days and suspended for 7 days.

Locations

Country Name City State
China Cancer Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Sun Yat-sen University Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate The sum of the maximum tumor diameter decreased by =30% 2years
Secondary progression-free survival The time before tumor diameters increased by less than 20% 2years
Secondary Overall survival The time before the patient died 2years
Secondary Duration of remission The duration of tumor remission 2years
Secondary Clinical response rate the number of patient with PR SD and CR 2years
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