Clinical trial · Interventional
Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
A Phase II Study of Endostatin in Combination With Oxaliplatin and Radiotherapy in Esophageal Cancer Patients.
NCT02745561CI-TRIAL-00021839unknownPhase 2ClinicalTrials.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)
Endostatin inhibits the pro-angiogenic action of basic fibroblast growth factor and vascular endothelial growth factor in esophageal cancer.This study aims at assessing the efficacy and safety of endostatin combined with concurrent chemoradiotherapy with Oxaliplatin in esophageal cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endostatin | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostatins | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy Arm
- description
- Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy. Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.
- interventionNames
- Drug: Endostatins
- Drug: Oxaliplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- response rate
- timeFrame
- week 3-4
- description
- Response rate will be done after 3-4 weeks following the last radiotherapy session.
Secondary outcomes (3)
- measure
- Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cytologically or histologically confirmed esophageal carcinoma 2. Age of 18 -80 3. ECOG performance status: 0-1; 4. No treatments prior to enrollment; 5. At least one measurable lesion on CT, MRI or esophageal barium exam; 6. Normal functions of heart, lung, liver, kidney and bone marrow Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL 7. Informed consent signed Exclusion Criteria: 1. Prior treatments of chemotherapy or irradiation; 2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable; 3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis; 4. Participating in other clinical trials; 5. Pregnancy, breast feeding, or not adopting birth control; 6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities 7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
References
Publications (1)
- DERIVEDLi W, Chen P, Zhang N, Song T, Wu S. Endostatin and Oxaliplatin-Based Chemoradiotherapy for Inoperable Esophageal Squamous Cell Carcinoma: Results of a Phase II Study. Oncologist. 2019 Apr;24(4):461-e136. doi: 10.1634/theoncologist.2019-0119. Epub 2019 Mar 8. PMID 30850562