Clinical trial · Interventional
Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial
NCT02749526CI-TRIAL-00059970terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual rate
Summary
Brief summary (as posted)
Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.
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 |
|---|---|---|---|
| Esophageal | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| "Endostar" | Drug | — | UNRESOLVED |
| Gimeracil and Oteracil Potassium (Tegafur) | Drug | — | UNRESOLVED |
| Liposo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostar combined with MPFC
- description
- Chemotherapy regimens (er degree + mPFC) : Endostar: degrees 30 mg civ24h d0-6; Liposo: 135 mg/m2 D1; cisplatin: D1-3, 25 mg/m2 Gimeracil and Oteracil Potassium (Tegafur): (40 mg bid Tegafur), D1-14. A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
- interventionNames
- Drug: "Endostar"
- Drug: Liposo
- Drug: cisplatin
- Drug: Gimeracil and Oteracil Potassium (Tegafur)
Primary outcomes (1)
- measure
- R0 Resection rate
- timeFrame
- up to 8 months
Secondary outcomes (1)
- measure
- pCR rate
- timeFrame
- up to 10 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * patients with esophageal cancer confirmed by histology or cytology; * according to TNM staging for Ⅲ period, previous untreated can be removed and potentially resectable esophageal cancer patients; * can eat more than liquid diet;No signs before esophageal perforation;No distant metastasis; * male or female, age 18 and 75 years old or less or more; * ECOG PS 0 \~ 1 minute; * is expected to survive period for 3 months or more, * enough blood function: absolute neutrophil count (ANC) or 2 x 109 / L and the • platelet count 100 x 109 / L or higher acuity 9 g/dL and hemoglobin;Liver function * enough: upper limit of total bilirubin acuities were normal (ULN);AST and ALT acuities were 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal or less (ULN); * enough renal function, serum creatinine or less normal limit (ULN) or calculated creatinine clearance or 60 mL/min. * basic normal ecg, no healing trauma; * always not received anti-tumor drug treatment; * ever had had surgery patients, request to study treatment began to have more than 4 weeks, and the patient has recovered; * a complete uterus of female in the group within 28 days before the study must have a negative pregnancy test results (except amenorrhea has 24 months).If the pregnancy test from the first time for more than 7 days, is the need for urine pregnancy test validation (within 7 days before the first delivery). * prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions; Exclusion Criteria: * there is a clear taxol allergy history; * pregnancy, nursing mothers, or have fertility but not women using contraception; * the existing serious acute infection, and not be controlled;Or fester sex and chronic infection, wound in delay no more; * the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension; * is not easy to control nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment;Primary brain tumors or CNS metastases illness did not get a control, has obvious symptoms in cranial hypertension or nerve spirit; * with bleeding tendency;
References
Publications (0)
Data not yet available
No reference posted for this study.