AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 2NTNCNCT03964753

Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Nab-paclitaxel and Cisplatin and surgery in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery… 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?
Nab-paclitaxel and Cisplatin and surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
202 participants
Where
1 siteChina
Study dates
24 Apr 2019to 24 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age ranges from 18 to 75 years
  • Radiographically, histologically or/and cytologically diagnosed resectable locally advanced middle-lower esophageal squamous cell carcinoma without distant metastasis,cT1N1M0 or T2-3N0-1M0(according to UICC esophageal cancer TNM staging system 8th edition)
  • Enhanced CT showed the presence of potentially resectable lesions. Resectability features included no evidence of mediastinal infiltration, No evidence of tracheobronchial fistula or tumor entry into the airway
  • Have not previously received systemic antitumor therapy for esophageal squamous cell carcinoma (Including radiotherapy, chemotherapy, targeted therapy, immunotherapy)
  • ECOG performance status 0-1
  • Expected survival more than 6 months
Show all 13Show fewer
  • No contraindications in the organ function tests before surgery
  • The laboratory test meet the following requirements:
  • Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5x ULN；AST and ALT) ≤ 2.5x ULN Renal function：Cr ≤ 1.5x ULN，Ccr ≥ 55 ml/min Coagulation function：INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range
  • Female patients of child-bearing age agree to take effective contraceptive measures during the study period and 6 months after reseach completion；Pregnancy tests in serum or urine must be negative 7 days prior to study enrollment；Non-lactating patients；male patients agree to take effective contraceptive measures during the study period and 6 months after reseach completion
  • Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)
  • Not participating in other clinical trials 4 weeks before the treatment
  • The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form.

Who cannot join

  • Histological confirmation of esophageal adenocarcinoma
  • with distant metastasis, without radical resection (stage IV)
  • Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
  • Grade 2 or above peripheral neuropathy or hemorrhage according to NCI CTCAE 4.03
  • Combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(BP≥160/95mmHg), unstable angina, a history of myocardial infarction in the past 6 months,Congestive heart failure>NYHA grade II, severe arrhythmia, pericardial effusion, etc.
  • Combined with severe ADH abnormal secretion syndrome, poorly controlled diabetes: more than 40 units of insulin per day need to be continuously administered; or 40 units of insulin per day for continuous use or not used, but fasting blood glucose is still above 14mmol / L, HbA1c above 9.0
Show all 15Show fewer
  • Long-term use of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues for more than 6 months,small doses of warfarin (≤1mg / day) or aspirin (≤100mg / day) for prevention purposes are not included
  • Major surgery within 4 weeks prior to enrollment, or surgical wounds have not fully healed
  • Operation can not use the stomach instead of esophageal cancer to reconstruct the digestive tract due to previous operation
  • Severe infection within 1 week prior to the start of study, requiring intravenous antibiotics, antifungal or antiviral therapy
  • Known to be allergic, highly sensitive or intolerable to research-related drugs or excipient
  • In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted
  • Any indicator shows chemotherapy and surgery contraindications
  • Women who are pregnant or lactating
  • The investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Junfeng Liu, PhD contact

13931152296

liujf@hbmu.edu

China1 site, 1 recruiting

  • Jun Feng Liu

    Shijiazhuang, Hebei, 050011

    Jun Feng Liu, PhD, 13931152296

    Recruiting

Other trials in China

About this study

Official title: The Effectiveness and Safety of Neoadjuvant Therapy With Nab-paclitaxel and Cisplatin Followed by Surgery Versus Surgery Alone for Locally Advanced Esophageal Squamous Cell Carcinoma

To verify the role of nab-paclitaxel in neoadjuvant therapy for esophageal squamous cell carcinoma, the investigators designed a prospective, randomized, controlled , multicente phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as neoadjuvant therapy followed by surgery versus surgery alone for esophageal squamous cell carcinoma.

Being tested
Nab-paclitaxel and Cisplatin, surgery
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.

  • Nab-paclitaxel and CisplatinDrug

    Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.

  • surgeryProcedure or surgery

    surgery

Study groups in NCT03964753
Study groupRoleWhat they receive
Neo-adjuvant chemotherapy groupExperimentalcisplatin and nab-paclitaxel: Nab-paclitaxel, 125mg/m(2), d1,d8, Cisplatin, 75mg/m(2), d1, 3 week, 2 cycles. Surgery: 4-6weeks after Neo-adjuvant chemotherapy
Receives: Drug: Nab-paclitaxel and Cisplatin; Procedure: surgery
Surgery aloneActive comparatorSurgery alone
Receives: Procedure: surgery

What is being measured

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

  1. OS

    Overall survival，From date of randomization until death due to any cause

    Measured: up to 5 years

Secondary outcomes (6)

  1. OS rate

    Overall survival rate

    Measured: 1 year,3years,5years

  2. DFS rate

    Disease free survival rate

    Measured: 1 year,3years,5years

  3. R0 resection rate

    R0 resection rate

    Measured: within 4 weeks following the operation

  4. Down-staging rate

    Down-staging rate

    Measured: within 6 weeks following the last dose of chemotherapy

  5. Rate of Operative Complications

    Measured: within 4 weeks following the operation

  6. Rate of Adverse Event

    Incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

    Measured: up to 6 weeks after the last dose of chemotherapy

Timeline

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

  1. First posted28 May 2019
  2. Study start24 Apr 2019
  3. Primary completion24 Jun 2026 (estimated)
  4. Study completion24 Dec 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
202 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03964753
Sponsor's protocol ID
HebeiJLiu
Acronym
NTNC
Status last verified
Oct 2023
First submitted
18 May 2019
Last updated
10 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel and Cisplatin and surgery in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital 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 13 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 10 Oct 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Junfeng Liu, PhD (13931152296, liujf@hbmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (time frame: up to 5 years). 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 NCT03964753.

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 10 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in