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Study of Endostar Combined With TP Regimen for Esophageal Cancer

Primary Purpose

Patients With Esophageal Cancer(Ⅱ-Ⅲ)

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

endostar+chemoradiotherapy

chemoradiotherapy

About this trial

This is an interventional treatment trial for Patients With Esophageal Cancer(Ⅱ-Ⅲ) focused on measuring endostar Esophageal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18 to 75 years;
Pathology confirmed as esophageal squamous cell carcinoma and Clinical stage is II-III;
Initial treatment, No surgery history;
ECOG 0~2;
Expected survival >=3 months;
All the patients should have target lesions that are measurable and evaluable;
Should be able to consume liquid diet, no esophageal perforation symptoms, no distant metastases;
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:

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

Sites / Locations

The second affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

objective response rate(ORR)

complete response(CR)+partial response(PR) according to RECIST 1.1

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

Secondary Outcome Measures

adverse event(AE)

adverse event according to NCI CTCAE V4.0

overall survival (OS)

overall survival is defined as the time from randomization to death from any cause

Full Information

NCT ID

NCT04164797

First Posted

November 13, 2019

Last Updated

November 22, 2019

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT04164797

Brief Title

Study of Endostar Combined With TP Regimen for Esophageal Cancer

Official Title

A Clinical Study of Endostar Combined With TP Regimen for Chemoradiotherapy in Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 25, 2019 (Anticipated)

Primary Completion Date

July 13, 2021 (Anticipated)

Study Completion Date

July 13, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

This study was a controlled clinical trial.A total of 402 patients with pathologically confirmed esophageal squamous cell carcinoma would be enrolled.Patients were randomly divided into two group ,with 201 in the treatment group and 201 in the control group.The treatment group was treated with endostar,chemotherapy (liposomal paclitaxel-carboplatin)and concurrent radiotherapy.The control group was treated with chemotherapy (liposomal paclitaxel-carboplatin)and concurrent radiotherapy .The efficiency and safety would be evaluated. The objective response rate and progress free survival would be analyzed.This data of this study might provide a more effective treatment for esophageal squamous cell carcinoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Esophageal Cancer(Ⅱ-Ⅲ)

Keywords

endostar Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

402 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

Arm Title

control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

endostar+chemoradiotherapy

Intervention Description

antiangiogenic drug+chemoradiotherapy

Intervention Type

Other

Intervention Name(s)

chemoradiotherapy

Intervention Description

chemoradiotherapy

Primary Outcome Measure Information:

Title

objective response rate(ORR)

Description

complete response(CR)+partial response(PR) according to RECIST 1.1

Time Frame

Time Frame: approximately 18 months

Title

progression-free survival(PFS)

Description

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

Time Frame: approximately 36 months

Secondary Outcome Measure Information:

Title

adverse event(AE)

Description

adverse event according to NCI CTCAE V4.0

Time Frame

Time Frame: approximately 36 months

Title

overall survival (OS)

Description

overall survival is defined as the time from randomization to death from any cause

Time Frame

Time Frame: approximately over 3-5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 to 75 years; Pathology confirmed as esophageal squamous cell carcinoma and Clinical stage is II-III; Initial treatment, No surgery history; ECOG 0~2; Expected survival >=3 months; All the patients should have target lesions that are measurable and evaluable; Should be able to consume liquid diet, no esophageal perforation symptoms, no distant metastases; 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: Patients who do not meet the pathological type of the inclusion criteria and the primary site; Allergic to recombinant endostar, carboplatin, paclitaxel, and contrast agents; Have a distant metastasis; The primary focal tumors or lymph node already had a surgical treatment (except for biopsy), chemoradiotherapy or targeted therapy; Patient who suffered from other malignant tumor; Subject with severe pulmonary and cardiopathic disease history; Pregnant woman or Lactating Women and Women in productive age who refuse take contraception in observation period; Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct; Received other medicine trials in past 4 weeks; Refuse or incapable to sign the informed consent form of participating this trial; The researchers judged other conditions that could affect clinical research and the results of the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hongbing Ma, Doctor tutor

Phone

13991845066

mhbxian@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

yuxing li, Master

Phone

18392067170

287012549@qq.com

Facility Information:

Facility Name

The second affiliated Hospital of Xi'an Jiaotong University

City

Xi'an,

State/Province

Shanxi

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

hongbing ma, Doctor tutor

Phone

13991845066

12. IPD Sharing Statement

Plan to Share IPD

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Study of Endostar Combined With TP Regimen for Esophageal Cancer

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