Clinical trial · Interventional
Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer
Recombinant Human Endostatin (Endostar) Combined With Concurrent Chemoradiotherapy for Advanced Non-small Cell Lung Cancer: A Multicenter, Randomized, Controlled Trial
NCT03588494CI-TRIAL-00033791unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent chemoradiotherapy (CCRT) | Combination Product | — | UNRESOLVED |
| Endostar for one cycle | Drug | — | UNRESOLVED |
| Endostar for two cycles | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- concurrent chemoradiotherapy (CCRT)
- description
- Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
- interventionNames
- Combination Product: concurrent chemoradiotherapy (CCRT)
- type
- EXPERIMENTAL
- label
- W1-CCRT
- description
- Endostar(15 mg/m2) was durative transfused every 24 hours for 5 days during the normalization window of the first chemoradiotherapy cycle(days -5～-1). Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33. Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Male or female patients, age: 18-70 years of age * 2\. Pathology was diagnosed as non-small cell lung cancer. According to the Tumor Node Metastasis（TNM）stage of the 8th edition of the International Association for the Study of Lung Cancer in 2017, And the pathological stage was identified as stage IIIa-b. * 3\. No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy. * 4\. Eastern Cooperative Oncology Group (ECOG) test scored 0-1. * 5\. Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L. * 6\. Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min. * 7\. Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL. * 8\. Forced vital capacity rate of one second（FEV1）\>0.8 litre. * 9\. Coagulation function is normal * 10\. lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard * 11\. Sign the inform consent form with good compliance Exclusion Criteria: * 1\. Carcinoid or small cell lung cancer * 2\. Patients with any distant metastasis * 3\. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix * 4\. Any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy). * 5\. Pregnancy or breastfeeding women * 6\. Women who may be pregnant but are unwilling to take appropriate contraception * 7\. Hereditary bleeding or coagulopathy
References
Publications (0)
Data not yet available
No reference posted for this study.