Study of Endostar Combined With TP Regimen for Esophageal Cancer

• Status: Unknown status
• Trial end date: 2021-07-13
• Target enrollment: 0
• Participant gender: All

Summary

a randomized controlled trial of endostar combined with TP regimen(liposomal paclitaxel-carboplatin) for chemoradiotherapy in esophageal squamous cell carcinoma(Ⅱ-Ⅲ)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
• Treatments: Endostar protein

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 < 1.5 ULN; ALT and AST < 2.0 ULN.Serum Cr is less than 1.5 ULN or endogenous creatinine clearance rate > 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:

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.