Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC

A Multicenter, Prospective Real World Study on Recombinant Human Endostatin (Endostar) Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III Non-small-cell Lung Cancer

NCT04161352•Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

The chemoradiotherapy (CCRT) is still a standard treatment for the unresectabl stage III NSCLC.However, prognosis following this treatment is generally poor, with 5-year survival of 15-20%. The result of published HELPER study had showed that Endostar, a kind of angiogenesis agent, in combination with CCRT could improve the efficacy and safety. In order to verify the rusults, the investigators design the current study.

Detailed Description

The current study is a observation study in the real world setting. The 500 patients in compliance with Enrollment Criteria will be as the objects of observation. The procedure of study include the period of screening, treating and follow-up. The duration of study is about two and half year. The data entrying will be done by CRC, using the EDC system. CRA will audit the quality of data regularly.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•untreated pathologically confirmed inoperable stage III NSCLC according to the 8th edition of the American Joint Committee on Cancer staging system;
•at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)1.1;
•18-75 years of age;
•Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1;
•10\) FEV1\>1.0 L;
•suitable function of bone marrow, liver, kidney and coagulation

Exclusion Criteria

•history of other malignant diseases, uncontrolled hypertension, any contraindications to chemoradiotherapy, pregnancy, breastfeeding or preexisting bleeding diatheses.
•\-

Key Dates

Start Date

November 25, 2019

Primary Completion Date

June 30, 2022

Completion Date

December 30, 2023

Last Updated

November 13, 2019

Enrollment

500

ESTIMATED participants

Conditions

Unresectable Stage III NSCLC

Contacts

Ming Chen, Doctor

CONTACT

18758875572 chenming@zjcc.org.cn

Honglian Ma, Doctor

CONTACT

18758871656 mahl@zjcc.org.cn

Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.

NCT04381494

Unresectable Stage III NSCLC

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions