Apatinib for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment (Poetry-1)

February 14, 2023 updated by: Yuhong Li

Efficacy and Safety of Apatinib Mesylate in Recurrent/Metastatic Esophageal Squamous Cell Carcinoma After the Failure of Conventional Treatment: a Phase II Clinical Trial

We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.

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

Esophageal cancer is one of the most common malignant tumor in China. In Asian countries, esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous cell carcinoma is usually poor and surgery is the only radical treatment. Cisplatin (DDP, cisplatin), 5 - Fluorouracil (5 - Fluorouracil, 5 - FU) and taxane are the most adopted chemotherapy agents, with efficacy rates of 33%-40% as first-line treatment for metastatic or recurrent esophageal squamous carcinoma and a median overall survival of 6-10 months. New agents were needed. Apatinib Mesylate is a small molecule VEGFR tyrosine kinase inhibitor. The anti-tumor mechanism of Apatinib is inhibiting angiogenesis in malignancy by inhibiting VEGFR. Apatinib Mesylate was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer. In the previous clinical practice, we observed that part of the patients with esophageal squamous cell carcinoma were resistant to conventional treatments benefited from Apatinib Mesylate. Based on the research situation mentioned above, we decided to conduct a phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.

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.
43

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:

  1. Male or female patients, age:18-75 years old.
  2. The ECOG physical status score: 0 to 2.
  3. Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
  4. Patients who previously received at least fluorouracil, platin or taxane-based palliative chemotherapy but failed(including patients who developed disease progression within half of a year after finishing their adjuvant or neoadjuvant chemotherapy) and patients who are intolerable or refuse to receive chemotherapy of agents mentioned above and develop disease progression within 2 months.
  5. Never received treatment of apatinib or any other anti-angiogenesis agent, such as sorafenib, sunitinib, bevacizumab, endostar etc.
  6. Lesions can be measured at single diameter by thoracic or abdominal computed tomography (CT) or magnetic resonance (MRI).Conventional methods should set at least 20mm as diameter or spiral CT 10 mm. Patients with increased or new lesions in radiotherapy area can be enrolled in the trial.
  7. Expected survival ≥ 3 months.
  8. If the subject have received surgery, the operative wound should be completely healed and without bleeding tendency.

  9. Baseline of blood routine and biochemical routine should meet the following criteria:

    • ANC≥1.5×10^9/L（1500/mm3）
    • PLT≥75×10^9/L
    • Hb≥9 g/dL
    • Serum bilirubin levels no higher than 2 times the upper limit of normal value.
    • AST and ALT no higher than 2.5 times the upper limit of normal value(no higher than 5 times the upper limit of normal value when patients developed liver metastasis).
    • Serum creatinine no higher than 1.5 times the upper limit of normal value.
  10. No malabsorption or other gastrointestinal disorders that will affect drugs absorption.
  11. No severe complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever > 38 ℃.
  12. Patients should be voluntary to the trial and provide with signed informed consent.
  13. Patients should have good compliance and cooperate with the evaluation of efficacy and adverse events and follow-ups according to the research plan.

Exclusion Criteria:

  1. Evidence of gastrointestinal bleeding tendency including: local active ulcer lesions with occult blood (+ +); melena and haematemesis within 2 months; possibilities of digestive tract hemorrhage.
  2. Evidence of hypertension that could not be controlled by drugs (SBP>140 mmHg, DBP>90 mmHg), grade I coronary heart disease, grade I arrhythmia(including QT interval prolonged by 450ms in male and 470ms in female) and grade I heart failure.
  3. Evidence of severe postoperative complications including intestinal obstruction, anastomotic fistula, pancreatic fistula and anastomotic stenosis.
  4. Evidence of urine protein ≥ (++) and 24 hours urinary protein quantitation >1.0 g.
  5. Fractures unhealed for long term or incompletely healed.
  6. Evidence of immunodeficiency disease, or other acquired or congenital immunodeficiency disease, or organ transplantation.
  7. Evidence of coagulation disorders (INR>1.5, APTT>1.5 ULN), bleeding tendency(INR should be in normal value without anticoagulation 14 days before randomization), usage of anticoagulation or Vit K antagonist including warfarin, heparin or any other analogue. When INR≤ 1.5, small dosage of warfarin(1 mg p.o, qd) or Aspirin (dosage < 100mg/d) in preventive purpose is allowed.
  8. Evidence of arterial/venous thrombotic events within 1 year before inclusion, including cerebrovascular accident (including TIA), deep vein thrombosis( vein thrombosis caused by venous catheterization in previous chemotherapy is excluded) and pulmonary embolism.
  9. Known severe hypersensitivity to Apatinib or any of the excipients of this product
  10. Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
  11. CNS metastases without radiotherapy and/or surgery. Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks.
  12. psychiatric illness that would prevent the patient from giving informed consent
  13. 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
  14. Patient is concurrently using other approved or investigational antineoplastic agent
  15. 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: Apatinib Mesylate
Patients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days.
Drug: Apatinib Mesylate
Patients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days.

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
Disease control rate
Time Frame: 6 months
6 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
Quality of life using EORTC QLQ C30 - scale
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Life quality evaluation using EORTC QLQ C30 - scale，once every 1 cycle assessment
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Quality of life using esophageal special scale QLQ - OES18
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Life quality evaluation using esophageal special scale QLQ - OES18, once every 1 cycle assessment
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time to progression
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence of Treatment-Emergent Adverse Events
Time Frame: Each follow up vist, assessed up to 12 months
Safety evaluation according to the CTCAE4.0 standard, once every 1 cycle assessment
Each follow up vist, assessed up to 12 months

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li Yuhong, MD, Sun Yat-sen University

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.
August 1, 2016

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).
November 21, 2016

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.
November 28, 2016

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.
November 29, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
  • Poetry-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

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