Gemcitabine Combined With Endostar and… | Clinical Trial

Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Xiaozhong Chen, Doctor

CONTACT

[email protected]

0571-88128202

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endostar and Envafolimab

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.

Primary outcomes

The proportion of patients with grade 3 or higher adverse events (AEs).

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaozhong Chen

CONTACT

[email protected]

88128202 ext. 571

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2028
First posted: Sep 28, 2023
Registry last updated: Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting