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NCT06055816 Clinical Trial

Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06055816
Other study ID # GEE study
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 28, 2023
Est. completion date June 30, 2028

Study information
Verified date September 2023
Source Zhejiang Cancer Hospital
Contact Xiaozhong Chen
Phone 88128202
Email chenxz@zjcc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 30, 2028
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Aged =65 years with newly pathologically confirmed NPC - Karnofsky performance status =60 - Clinical stage III-IVA (Union for International Cancer Control and American Joint Committee on Cancer staging system for NPC, 8th edition) - Adequate organ function Exclusion Criteria: - Cancer history - Prior radiotherapy, cytotoxic chemotherapy, immunotherapy or target therapy - Life-expectance within 6 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Endostar and Envafolimab
Neoadjuvant therapy consisting of gemcitabine (1000mg/m2 d1,8) , endostar (150mg 3-day continuous infusion) and envafolimab (240mg d1) was given every 3 weeks for 3 cycles. Endostar, administered every 3 weeks (150mg 3-day continuous infusion), was given concurrently with intensity-modulated radiotherapy.

Locations
Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The proportion of patients with grade 3 or higher adverse events (AEs). The primary endpoint was the safety profile. AEs were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Up to 24 weeks
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