Patients With Esophageal Cancer(?-?) Clinical Trial
Official title:
A Clinical Study of Endostar Combined With TP Regimen for Chemoradiotherapy in Esophageal Cancer
a randomized controlled trial of endostar combined with TP regimen(liposomal paclitaxel-carboplatin) for chemoradiotherapy in esophageal squamous cell carcinoma(Ⅱ-Ⅲ)
| Status | Recruiting |
| Enrollment | 402 |
| Est. completion date | July 13, 2021 |
| Est. primary completion date | July 13, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | The second affiliated Hospital of Xi'an Jiaotong University | Xi'an, | Shanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Second Affiliated Hospital of Xi'an Jiaotong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | objective response rate(ORR) | complete response(CR)+partial response(PR) according to RECIST 1.1 | Time Frame: approximately 18 months | |
| Primary | progression-free survival(PFS) | progression-free survival is defined as the time from enrollment to the date of first document disease progression or death from any cause | Time Frame: approximately 36 months | |
| Secondary | adverse event(AE) | adverse event according to NCI CTCAE V4.0 | Time Frame: approximately 36 months | |
| Secondary | overall survival (OS) | overall survival is defined as the time from randomization to death from any cause | Time Frame: approximately over 3-5 years |