Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT00813332
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years old, males or females;
2. Patients with NSCLC confirmed by histopathology or cytology who need second-line chemotherapy, including progressive disease cases during or in 3 months posterior to end of first-line chemotherapy( at least 4 cycles done) and cases with intolerant adverse effects in first-line chemotherapy( at least 4 cycles done); neo-adjuvant chemotherapy and targeted therapy(EFGR-TKIs) not to be served as first-line chemotherapy; 3 months of clearance needed for neo-adjuvant chemotherapy and 1 month for targeted and first-line chemotherapy;
3. Local advanced and metastatic cases with tumor foci that can be evaluated by CT, MRI or PET-CT; at least one diameter ≥ 1 cm (including metastatic lymph nodes) confirmed by CT scan or ≥ 1 cm by spin CT or PET-CT );
4. No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤1.0×UNL; Hepatic function: transaminase≤1.5×UNL, BIL≤×UNL;
5. Karnofsky performance scale≥60 or ECOG performance scale≤ 2; expected survival time≥3 months;
6. No allergic history to biological agents and taxane agents;
7. Patients are voluntary to participate and sign the informed contents.
Exclusion Criteria:
1. Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
2. With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
3. With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension;
4. Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
5. Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
6. Uncontrolled diabetes and contraindication to corticoid agents;
7. Obvious hemorrhage tendency;
8. Allergic to any drug in the trial;
9. Patients with a second tumor;
10. Patients participating in other clinical trials;
11. Patients treated by Endostar or Docetaxel (excluding neo-chemotherapy) included combination chemotherapy previously;
12. Foci to be evaluated for response in trial treated by radiation in 6 months.
13. Other conditions that are regarded for exclusion by the trialists.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00813332
Study Brief:
Protocol Section:
NCT00813332