Clinical trial · Interventional
Curative Effect Study of Endostatin Combined With Chemoradiotherapy to Non-small-cell Lung Cancer
Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
NCT01218594CI-TRIAL-00008283DP-EN-RTunknownPhase 2Results postedClinicalTrials.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 evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III 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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostatin combine CCRT
- description
- 7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
- interventionNames
- Drug: Endostatin
Primary outcomes (1)
- measure
- Response Rate (RR)
- timeFrame
- 4 weeks after CCRT
- description
- Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age * untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC * weight loss of less than 10% in the past 6 months * performance status (PS) of 0 to 1 * forced vital capacity in 1 second (FEV1) higher than 0.8 L * measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST). * absolute neutrophil count (ANC) of ≥ 1500/μL * hemoglobin ≥ 10 mg/dL * platelet ≥ 100,000/μL * serum creatinine ≤ 1.25 times of upper limit of normal (ULN) * calculated creatinine clearance (CrCl) of ≥ 60 ml/min * bilirubin 1.5×ULN * AST and ALT less than 2.5×ULN * alkaline phosphatase less than 5×ULN. Exclusion Criteria: * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * malnutrition (loss of ≥ 20% of the original body weight) * sensor or motor neuropathy \> grade I * second primary malignancy, except for non-melanoma skin cancer * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women * preexisting bleeding diatheses or coagulopathy * Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway
References
Publications (1)
- DERIVEDBao Y, Peng F, Zhou QC, Yu ZH, Li JC, Cheng ZB, Chen L, Hu X, Chen YY, Wang J, Wang Y, Ma HL, Xu ZM, Lu RB, Deng XW, Chen M. Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer. Radiother Oncol. 2015 Feb;114(2):161-6. doi: 10.1016/j.radonc.2014.11.039. Epub 2014 Dec 9. PMID 25497558