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

Phase 2

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Endostar and Envafolimab

• Registration Number: NCT06055816
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-14
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-24
• Last Update Submitted: 2023-09-24
• Study Start: 2023-09-28
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-09-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine Combined With Endostar and Envafolimab	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.

Primary Outcome Measures

Name	Time	Method
The proportion of patients with grade 3 or higher adverse events (AEs).	Up to 24 weeks	The primary endpoint was the safety profile. AEs were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China