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

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06055816
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
57.1
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Endostar and Envafolimab
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
Anticipated Study Start Date :
Sep 28, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Jun 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gemcitabine Combined With 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhejiang Cancer Hospital Hangzhou Zhejiang China 325000

Sponsors and Collaborators

  • Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Xiaozhong Chen, Department of Radiation Oncology, Zhejiang Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chen Xiaozhong, Professor, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT06055816
Other Study ID Numbers:
  • GEE study
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Carcinoma
Endostar protein

Study Results

No Results Posted as of Sep 28, 2023