Recombinant endostatin (Sulijia) combined chemotherapy with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III trial

Recombinant endostatin ( Sulijia) combined chemotherapy with Vinorelbine and Cisplatin (NP) plus maintenance therapy with Sulijia for advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001539

Enrollment

Unknown

Registered

2011-08-12

Start date

2011-09-01

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

Advanced or metastatic (IV) NSCLC

Interventions

Control group:Placebo combined chemotherapy with Vinorelbine and Cisplatin (NP)

Experimental group:Sulijia combined chemotherapy with Vinorelbine and Cisplatin (NP)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 70 years old; 2. Patients with histological confirmed stage IV NSCLC; 3. According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter >=10mm by spiral CT, PET-CT, with the largest diameter >=20mm by ordinary CT and MRI; 4. general condition ECOG performance scale (PS) 0-1; 5. Life expectancy of more than 3 months; 6. No major organ dysfunction and laboratory indicators should meet the following requirements: absolute neutrophil count > 1.5*10^9/L, platelet count> 90*10^9/L, hemoglobin> 9g/dL; liver function: serum bilirubin was less than 2* maximum normal value; ALT and AST were less than 2.5*maximum normal value; BUN, Cr within 80% of normal range; 7. Patients could understand the circumstances of this study and those who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time; 2. Patients who have uncontrolled brain metastasis; 3. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer; 4. Pregnant or lactating women; 5. Severe infected patients; 6. Patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure; 7. Patients who have vein thrombus; 8. Patients who have psychiatric illness; 9. Patients who are allergic to E. coli preparation; 10. Researchers believe that those who do not fit.

Design outcomes

Primary

Measure	Time frame
progression free survival (PFS);	—

Secondary

Measure	Time frame
Overall survival (OS) and Safety of Sulijia;disease control rate(DCR) and objective response rate(ORR);	—

Countries

China

Contacts

Public ContactYuankai Shi

syuankai@yahoo.cn+86 010 67781331

Outcome results

None listed

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