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randomized control trial of Endostar in deferent time combined with DP regime for IIIB-IV stage NSCLC

Randomized contro trial of Endostar in deferent time combined with DP regime for IIIB-IV stage NSCLC

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001891
Enrollment
Unknown
Registered
2012-01-09
Start date
2011-06-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None Small Cell Lung Cancer

Interventions

3:Endostar combined with DP regime in three different times

Sponsors

Nantong Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of NSCLC according to Histopathology and/or Cytology, without antitumor therapy; 2. Advanced tumor patients by imaging, At least 1 measurable tumor mass Previously first therapy (the tumor mass Diameter>=20mm by Chest radiography or CT or MRI scanning, Spira CT Diameter>=10mm); 3. Eastern Cooperative Oncology Group status 0-2; 4. Estimate Survival period>=3monthes; 5. aged 18 to 75 years old; 6. Conform to Chemotherapy Indications and Basic requirements, for: Peripheral blood Almost normal, hart, liver and Kidney fanction. No obvious abnormality, ECG Almost normal. The body has no healing wounds; 7. Laboratory indicators must meet the following requirements:Peripheral hemogram:White blood cell>=3.5*10^9 cells/L, Platelets>=80*10^9 cells /L, Hb>=90g/L. Renal function: Cr<=2.0*UNL(upper limit of norma); Liver function: ALT <=1.5*ULN; Total Bilirubin<=1.5*ULN. if have liver metastases, ALT <=5*ULN; Total Bilirubin<=2.5*ULN; 8. The group participated in voluntary, previously signed informed consent, good compliance, can be matched with the experimental observation.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, in the period of duration but fails to take effective contraceptive measures; 2. Less measurable lesions such as pleural effusion of lung cancer, lymphatic inflammation, ascites, peritoneal cancer lesions, diffuse hepatic involvement, bone metastasis; 3. Brain metastasis (The radiation control, is not dependent on hormones of patients with brain metastases should be allowed into the group); 4. Severe, uncontrolled internal disease and infection; 5. There are severe lesions, or important organs function failure, such as decompensated heart, lung, kidney failure can lead to tolerance of chemotherapy patients; 6. Previous or simultaneous with other malignant tumors; 7. At the same time using other experimental drugs or other clinical trials; 8. The only observable effect of radiotherapy after previous had lesions; 9. Peripheral neuropathy symptoms,NCI Classification>II degree; 10. A past history of mental illness.

Design outcomes

Primary

MeasureTime frame
VEGF, ES, PDGF-C, CR, PR, SD;VEGF concentration;

Countries

China

Contacts

Public ContactXiaodong Zhang
xiaodongzhang@csco.org.cn+86 0513 86729150

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026