Endostar Combined With Concurrent Radiochemotherapy for Treatment of Unresectable Stage III NSCLC (R-helper)

University of Chinese Academy Sciences

Status: Unknown

Conditions: Unresectable Stage III NSCLC

Study type: Observational

Funder types: Other

Identifiers

NCT04161352

Endo-CCRT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.