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Multicenter, postoperative, randomized controlled, open label, phase II clinical trial of recombinant human endostatin on vascular normalization for esophageal squamous cell carcinoma

Multicenter, postoperative, randomized controlled, open label, phase II clinical trial of recombinant human endostatin on vascular normalization for esophageal squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003908
Enrollment
Unknown
Registered
2013-11-25
Start date
2013-12-20
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

esophageal squamous cell carcinoma

Interventions

1:IMRT is administered with chemotherapy from week 1 to week 8, PGTV-T 66-70Gy/33-35f, PGTV-N 60-66Gy/30-33f, PCTV-T 50-56Gy/25-28f, 50-56Gy/25-28f, docetaxel 60-75mg/m2 day 1 and cisplatin 25mg/m2 da
2:IMRT is administered with chemotherapy from week 1 to week 8, PGTV-T 66-70Gy/33-35f, PGTV-N 60-66Gy/30-33f, PCTV-T 50-56Gy/25-28f, 50-56Gy/25-28f. docetaxel 60-75mg/m2 day 1 and cisplatin 25mg/m2 da

Sponsors

Sichuan Cancer Hospital & Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age18-80 years old, male or female; 2. Karnofsky score>=70; 3. Histologically confirmed diagnosis of esophageal squamous cell carcinoma; 4. Measurable Primary tumors; 5. Estimated life expectancy of at least 12 weeks; 6. Women in productive age should guarantee use contraceptives during study period; 7. WBC >=4.0*10^9/L, Absolute neutrophil count (ANC) >=2.0*10^9/L, Platelets >=100*10^9/L, Hemoglobin >=90g/L(without blood transfusion); 8. Liver function: AST (SGOT)/ALT (SGPT) <=2.5*upper limit of normal, Bilirubin <=1.5*upper limit of normal; 9. Renal function: Creatinine <=1.5*upper limit of normal; 10. This treatment is First treatment process; 11. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Have a distant metastasis; 2. The primary focal tumors or lymph node already had a surgical treatment (except for biopsy); 3. Already had a radiotherapy for primary focal or lymph node; 4. Patient who received the the epidermal growth factor targeted therapy; 5. The primary focal had received chemoradiotherapy or immunotherapy; 6.Patient who suffered from other malignant tumor (except for cured basal cell carcinoma or carcinoma in situ of cervix); 7. Subject who have taken other drug test in 1 month; 8. Pregnant woman or Lactating Women and Women in productive age who refuse take contraception in observation period; 9. Subject with a severe allergic history or idiosyncratic; 10. Subject with severe pulmonary and cardiopathic disease history; 11. Refuse or incapable to sign the informed consent form of participating this trial; 12. Drug abuse or alcohol addicted; 13. Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
Serum VEGF;CT perfusion parameters: BV, BF, MTT, PS;Microvessel density (MVD) detection with endothel;Microvessel density (MVD) detection with endothel;Short term effective rate (RR);median survival time;overall survival;Quality of life(QoL);

Countries

China

Contacts

Public ContactTao Li

Sichuan Cancer Hospital & Institute

litaoxmf@126.com+86 18908178818

Outcome results

None listed

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