Endostar Combined With Paclitaxel and Nedaplatin in Treating Patients With Recurrent or Metastatic Esophageal Cancer

February 14, 2023 updated by: Yuhong Li

A Phase II Trial of Recombinant Human Endostatin Injection (Endostar) Combined With Paclitaxel and Nedaplatin as First-line Therapy in Treating Patients With Recurrent or Metastatic Esophageal Cancer

This phase Ⅱ study was designed to evaluate the efficacy and safety of endostar combined with paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or metastatic esophageal squamous cell cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The prognosis of recurrent or metastatic esophageal squamous cell cancer is poor. However, there is still no standard chemotherapy regimen recommended for this disease because of the lack of trails. Currently, anti-angiogenesis therapy had been proved to improve the survival successfully in colorectal cancer, non-small cell lung cancer, breast cancer, glioma and kidney cancer. Recent studies showed that the high level of VEGF was negative correlated with the prognosis of esophageal cancer. Endostar, as a novel endogenous angiogenesis inhibitors, was proved to significantly inhibited the proliferation and metastasis in esophageal cell lines and animal models. A retrospective study also reported the safety and efficacy of the combination therapy of paclitaxel liposome and recombinant human endostatin. Based on the basis above, we designed this phase Ⅱ study to evaluate the efficacy and safety of endostar combined with paclitaxel and nedaplatin as first-line therapy in treating patients with recurrent or metastatic esophageal squamous cell cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients have provided a signed Informed Consent Form
  • Age: 18-75 years old
  • Histologically confirmed diagnosis of recurrent or metastatic or unresectable advanced esophageal squamous cell carcinoma
  • Patients have neither received any palliative chemotherapy nor adjuvant chemotherapy or concurrent chemotherapy with taxane based drugs or large doses cisplatin (cumulative dose ≥ 300mg/m2). The time from the last adjuvant or concurrent chemotherapy to relapse or metastasis should more than 6 months.
  • Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria; Targeted lesions should not include primary esophageal lesions
  • Life expectancy ≥ 3 months
  • Karnofsky score ≥70

  • Patient has adequate bone marrow and organ function

    • Leukocyte ≥ 3.5 x 10^9/L
    • eAbsolute Neutrophil Count (ANC) ≥ 1.8 x 10^9/L
    • Platelets ≥ 90 x 10^9/L
    • Hemoglobin ≥ 10g/L

  • Patient has adequate liver function

    • AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
    • Serum bilirubin ≤ 1.2 x ULN
    • Creatinine ≤ 1.2 times ULN
    • Alkaline phosphatase ≤ 5.0 times ULN
  • No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃.
  • Patients with effective contraceptive measures
  • Expect good compliance

Exclusion Criteria:

  • Patients have received radiotherapy in 3 months.
  • Patients with relapse recurrent or metastatic lesions in radiated area.
  • Patient has received previous treatment with VEGF inhibitors
  • Known severe hypersensitivity to the drugs in the experimental chemotherapy or any of the excipients of these products
  • Patients without measureable lesions
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases
  • Patients with chronic diarrhea
  • Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ
  • psychiatric illness including CNS metastases that would prevent the patient from giving informed consent
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Paclitaxel+Nedaplatin+Endostar
Patients will receive chemotherapy every 3 weeks: Paclitaxel 175mg/m2 IV over 3 hours on Day 4; Nedaplatin 80mg/m2 IV over 1 hours on Day 4; Endostar 3mg/day for 14 days continuous infusion from Day 1 to Day 14.
Drug: Paclitaxel+Nedaplatin+Endostar
Patients will receive chemotherapy every 3 weeks: Paclitaxel 175mg/m2 IV over 3 hours on Day 4; Nedaplatin 80mg/m2 IV over 1 hours on Day 4; Endostar 3mg/day for 14 days continuous infusion from Day 1 to Day 14
Other Names:
  • Paclitaxl
  • Nedaplatin
  • Endostar
  • Recombinant Human Endostatin Injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression free survival
Time Frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date of first drug administration until the date of death, assessed up to 36 months
From the date of first drug administration until the date of death, assessed up to 36 months
Overall response rate (ORR)
Time Frame: From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
From the date of first drug administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Number of participants with AEs and SAEs as a measure of Safety
Time Frame: Each follow up vist, assessed up to 2 years
Each follow up visit, assessed up to 3 years. Date will be assessed at each study visiting using NCI CTCAE version 4.0.
Each follow up vist, assessed up to 2 years
Quality of life
Time Frame: Time from day 1 to date of death, assessed up to 3 years
Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18
Time from day 1 to date of death, assessed up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuhong Li

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Endo-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings