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

NCT ID: NCT06055816

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2028-06-30

Brief Summary

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

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Endostar and Envafolimab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Xiaozhong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaozhong Chen

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaozhong Chen

Role: CONTACT

88128202 ext. 571

Facility Contacts

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Xiaozhong Chen, Doctor

Role: primary

0571-88128202

Other Identifiers

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GEE study

Identifier Type: -

Identifier Source: org_study_id

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