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Esophageal Squamous Cell CarcinomaPhase 2NCT02350517

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

A Phase 2 study testing Paclitaxel+Nedaplatin+Endostar in people with Esophageal Squamous Cell Carcinoma, run by Yuhong Li at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Paclitaxel+Nedaplatin+Endostar
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
Jan 2015to Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Paclitaxel+Nedaplatin+Endostar
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel+Nedaplatin+EndostarDrug

    Also called Paclitaxl, Nedaplatin, Endostar, Recombinant Human Endostatin Injection

    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

Study groups in NCT02350517
Study groupRoleWhat they receive
Paclitaxel+Nedaplatin+EndostarExperimentalPatients 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.
Receives: Drug: Paclitaxel+Nedaplatin+Endostar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Measured: 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 outcomes (4)

  1. Overall survival

    Measured: From the date of first drug administration until the date of death, assessed up to 36 months

  2. Overall response rate (ORR)

    Measured: 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

  3. Number of participants with AEs and SAEs as a measure of Safety

    Each follow up visit, assessed up to 3 years. Date will be assessed at each study visiting using NCI CTCAE version 4.0.

    Measured: Each follow up vist, assessed up to 2 years

  4. Quality of life

    Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18

    Measured: Time from day 1 to date of death, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2019
  4. Study completionDec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02350517
Sponsor's protocol ID
Endo-17
Status last verified
Feb 2023
First submitted
24 Jan 2015
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel+Nedaplatin+Endostar in people with Esophageal Squamous Cell Carcinoma, run by Yuhong Li at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02350517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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