Study of Endostar Combined With TP Regimen for Esophageal Cancer
NCT ID: NCT04164797
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
402 participants
INTERVENTIONAL
2019-11-25
2021-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment group
endostar : 7.5mg/m2/d,continuous infusion for 5 days in week 1、3、5、7, chemotherapy：paclitaxel liposomes 50mg / m2, ivgtt, d8, 15, 22, 29, 36, carboplatin AUC 2, ivgtt d8, 15, 22, 29, 36 radiotherapy：EBRT，61.2 Gy，1.8Gy/d
endostar+chemoradiotherapy
antiangiogenic drug+chemoradiotherapy
control group
chemotherapy：paclitaxel liposomes 50mg / m2, ivgtt, d8, 15, 22, 29, 36, carboplatin AUC 2, ivgtt d8, 15, 22, 29, 36 radiotherapy：EBRT，61.2 Gy，1.8Gy/d
chemoradiotherapy
chemoradiotherapy
Interventions
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endostar+chemoradiotherapy
antiangiogenic drug+chemoradiotherapy
chemoradiotherapy
chemoradiotherapy
Eligibility Criteria
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Inclusion Criteria
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.
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.
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Responsible Party
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Locations
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The second affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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hongbing ma, Doctor tutor
Role: primary
Role: backup
Other Identifiers
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SecondXianJiaotongU
Identifier Type: -
Identifier Source: org_study_id
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