Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
40
1 country
1
Brief Summary
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2023
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
ExpectedSeptember 28, 2023
September 1, 2023
1 year
August 14, 2023
September 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Gemcitabine Combined With Endostar and Envafolimab
EXPERIMENTALNeoadjuvant 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cancer history
- Prior radiotherapy, cytotoxic chemotherapy, immunotherapy or target therapy
- Life-expectance within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaozhong Chen
Department of Radiation Oncology, Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 14, 2023
First Posted
September 28, 2023
Study Start
September 28, 2023
Primary Completion
September 30, 2024
Study Completion (Estimated)
June 30, 2028
Last Updated
September 28, 2023
Record last verified: 2023-09