Study of Endostar Combined With TP Regimen for Esophageal Cancer

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)

Study Overview

• Status: Unknown
• Conditions: Patients With Esophageal Cancer(Ⅱ-Ⅲ)
• Intervention / Treatment: Drug: endostar+chemoradiotherapy; Other: chemoradiotherapy

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

• Study Type: Interventional
• Enrollment (Anticipated): 402
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an,, Shanxi, China
      • Recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: hongbing ma, Doctor tutor
      • Contact: Phone Number: 13991845066

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: endostar+chemoradiotherapy; antiangiogenic drug+chemoradiotherapy
Active Comparator: 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	Other: chemoradiotherapy; chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective response rate(ORR)	complete response(CR)+partial response(PR) according to RECIST 1.1	Time Frame: approximately 18 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event(AE)	adverse event according to NCI CTCAE V4.0	Time Frame: approximately 36 months
overall survival (OS)	overall survival is defined as the time from randomization to death from any cause	Time Frame: approximately over 3-5 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2019
• Primary Completion (Anticipated): July 13, 2021
• Study Completion (Anticipated): July 13, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 25, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: endostar Esophageal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostar protein
• Other Study ID Numbers: SecondXianJiaotongU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No