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A clinical study for Endostar combined with TP regimen concurrent radiotherapy for esophageal cancer: a randomized controlled trial

A clinical study for Endostar combined with TP regimen concurrent radiotherapy for esophageal cancer: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021279
Enrollment
Unknown
Registered
2019-02-10
Start date
2019-05-30
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Pathology confirmed as esophageal squamous cell carcinoma and Clinical stage is II-III; 3. Initial treatment, No surgery history; 4. ECOG 0~2; 5. Expected survival >=3 months; 6. All the patients should have target lesions that are measurable and evaluable; 7. Should be able to consume liquid diet, no esophageal perforation symptoms, no distant metastases; 8. The main organ function is normal, which meets the following criteria: (1) The standard of blood test should be met (14 days without blood transfusion and blood products, no G-CSF and other hematopoietic stimulation factor correction): Hb>=100g/L;ANC>=1.5x10^9/L;PLT>=100x10^9/L; (2) Biochemical inspection shall meet the following criteria: TBIL 50 ml/min (the Cockcroft Gault formula); (3) Pulmonary function FEV1 >=1 L or >50% of corresponding value of normal people; 9. Female during the reproductive period should be ensured contraception during the study period; 10. Participants voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients who do not meet the pathological type of the inclusion criteria and the primary site; 2. Allergic to recombinant endostar, carboplatin, paclitaxel, and contrast agents; 3. Have a distant metastasis; 4. The primary focal tumors or lymph node already had a surgical treatment (except for biopsy), chemoradiotherapy or targeted therapy; 5. Patient who suffered from other malignant tumor; 6. Subject with severe pulmonary and cardiopathic disease history; 7. Pregnant woman or Lactating Women and Women in productive age who refuse take contraception in observation period; 8. Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct; 9. Received other medicine trials in past 4 weeks; 10. Refuse or incapable to sign the informed consent form of participating this trial; 11. The researchers judged other conditions that could affect clinical research and the results of the study.

Design outcomes

Primary

MeasureTime frame
Objective response rate;Progression-free survival;

Secondary

MeasureTime frame
Disease control rate;Overall survival;drug safety;Blood routine examination;

Countries

China

Contacts

Public ContactHongbing Ma
mhbxian@126.com+86 13991845066

Outcome results

None listed

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