Back to resultsGemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostar and Envafolimab
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
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
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine Combined With Endostar and Envafolimab
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06055816
First Posted
August 14, 2023
Last Updated
September 24, 2023
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06055816
Brief Title
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Official Title
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine Combined With Endostar and Envafolimab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Endostar and Envafolimab
Intervention Description
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 Measure Information:
Title
The proportion of patients with grade 3 or higher adverse events (AEs).
Description
The primary endpoint was the safety profile. AEs were scored according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaozhong Chen
Phone
88128202
Ext
571
Email
chenxz@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen
Organizational Affiliation
Department of Radiation Oncology, Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, Doctor
Phone
0571-88128202
Email
chenxz@zjcc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
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