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Squamous Cell Carcinoma of EsophagusPhase 2NCT02041819

Neoadjuvant Chemotherapy of Nimotuzumab Plus Nab-Paclitaxel in Squamous Cell Carcinoma of Esophagus

A Phase 2 study testing Nimotuzumab in people with Squamous Cell Carcinoma of Esophagus, run by Zhejiang University at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Squamous Cell Carcinoma of Esophagus
What is being tested?
Nimotuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Feb 2014to Jan 2017
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

  • Histologically confirmed squamous cell carcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I)
  • Locally advanced disease that is technically operable with curative intent (R0)
  • T3, N0 OR T1-3, N+ OR T4, Nx
  • No T1-2, N0
  • No inoperable T4 (unequivocal organ involvement)
  • No distant metastasis, including M1a lymph node status
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  • Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology
  • No carcinoma of the cervical esophagus
  • Obstructive tumors allowed

Who cannot join

  • Not suitable to surgery
  • cervical Esophageal Carcinoma(distance of incisor tooth<19cm)
  • early Esophageal Carcinoma(Stage I)
  • complete esophageal obstruction，Esophageal perforation or hematemesis
  • other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ
  • pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
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  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
  • History of serious allergic or castor oil allergy
  • Patients who are not suitable to participate in the trial according to researchers

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first affiliated hospital, Zhejiang University

    Zhejiang, Zhejiang, 310003

Other trials in China

About this study

Official title: A Phase II Trial of Neoadjuvant Chemotherapy With Nimotuzumab Plus Nanoparticle Albumin-bound Paclitaxel and Cisplatin Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus

Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR),has been shown to be effective and safe in some studies with head-neck cancers.Nab-paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel.However,the safety and efficacy of Nimotuzumab plus nab-paclitaxel regimen is uncertain in neoadjuvant therapy in esophageal cancer.The investigators then initiated a phase II clinical trial with Nimotuzumab plus Nab-paclitaxel/cisplatin as the neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma to observe the efficacy and safety of the combination.

Read the detailed description

In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of Nimotuzumab plus Nab-paclitaxel/cisplatin as perioperative therapy for patients with resectable esophageal squamous cell carcinoma.

Being tested
Nimotuzumab
Keywords
Neoadjuvant chemotherapy, Nimotuzumab, Nab-Paclitaxel, Carcinoma of Esophagus
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

What participants receive

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

  • NimotuzumabDrug

    Also called nimo

    Nimotuzumab: 200mg,IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).

Study groups in NCT02041819
Study groupRoleWhat they receive
Nimotuzumab nab-paclitaxel cisplatinExperimentalNimotuzumab: 200mg,IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36). Cisplatin: 75mg/m2,IV on days 1，22. Nab-paclitaxel: 125mg/m2,IV on days 1,8,22,29. patients will receive radical operation 4-6 weeks after Neoadjuvant therapy.
Receives: Drug: Nimotuzumab

What is being measured

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

  1. response rate

    pathological response rate and clinical response rate

    Measured: From date of treatment until the date of progression, assessed up to 2 months

Secondary outcomes (3)

  1. Overall survival

    Measured: Overall survival was measured from the date of treatment to the date of death, or last follow-up,assessed up to 48 months

  2. Progression-free survival

    Measured: Progression-free survival was measured from the date of treatment to the date of first evidence of relapse or death due to any cause,assessed up to 36 months

  3. Adverse events

    Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0

    Measured: During the chemotherapy,an expected average of 3 weeks

Timeline

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

  1. First posted22 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2017 (estimated)

Why it stopped: No recruitment

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02041819
Sponsor's protocol ID
ZYTOP1405
Status last verified
Mar 2015
First submitted
10 Jan 2014
Last updated
5 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab in people with Squamous Cell Carcinoma of Esophagus, run by Zhejiang University 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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 5 Mar 2015. 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 was withdrawn before enrolling participants, so there are no results.

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?

response rate (time frame: From date of treatment until the date of progression, assessed up to 2 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 NCT02041819.

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 5 Mar 2015.

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