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Esophageal CancerPhase 2NCT05866510

Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer

A Phase 2 study testing Utidelone and anlotinib in people with Esophageal Cancer, run by Peking University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the safety, tolerance and efficacy of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who failed Standard first line therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Utidelone and anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
3 sitesChina
Study dates
15 May 2023to 30 Apr 2024
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

  • Histological and/or cytology confirmed advanced or unresectable recurrent esophageal carcinoma
  • All patients had failed first-line chemotherapy (disease progression or unacceptable toxicity occurs).
  • Patients may also be included if they receive standard neoadjuvant/adjuvant chemotherapy and relapse within 6 months of completion.
  • All patients were not accepted any treatment(chemotherapy, radiotherapy, surgery, etc.) within 4 weeks before enrollment.
  • The subject has at least one evaluable lesion (measurable or non-measurable) by the RECIST 1.1.
  • Male or female, ≥ 18 years of age, ≤ 75 years of age.
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  • ECOG performance status 0-1.
  • Patients with a life expectancy of more than 3 months.
  • Baseline routine blood tests within 1 week prior to enrollment is normal. No rhG-CSF use and no blood transfusion/EPO etc. within 14 days prior to enrollment.
  • Neutrophil count (ANC) ≥ 1.5 × 109/L.
  • Hemoglobin ≥9.0 g/dL.
  • platelet count (PLT) ≥ 80 × 109/L
  • Blood biochemistry test result is normal within 1 week prior to enrollment (based on normal values at each site's laboratory).
  • Total bilirubin (TBIL) ≤ 1.5× the upper limit of normal value (ULN)
  • Serum Glutamic Pyruvic Transaminase/Alanine Amino transferase (SGPT /ALT) ≤ 3× ULN (in the case of liver metastases ≤ 5 × ULN)
  • Serum Glutamic-oxaloacetic Transaminase/Aspartate Aminotransferase (SGOT /AST) ≤ 3× ULN (in the case of liver metastases ≤ 5 × ULN)
  • Creatinine clearance (Ccr) ≥50 ml/min.
  • Fertile males and females of childbearing potential must agree to use effective contraception during the study and within 90 days after the last dose. The blood or urine pregnancy test for female patients of childbearing age prior to enrollment must be negative.
  • Patients must sign the informed consent form and commit to complying with the requirements of this study.

Who cannot join

  • Patients who have received antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or antitumor herbal therapy, within 4 weeks. With the exception of the following:
  • Nitrosoureas or mitomycin C within 6 weeks prior to the first use of the study drug;
  • Oral fluorouracil and small molecule targeted drugs for 2 weeks prior to the first use of the study drug or within the drug's 5 half-life (whichever is longer);
  • Chinese medicines with antitumor indications within 2 weeks before the first use of the study drug.
  • Major organ surgery (excluding puncture biopsy) within 4 weeks prior to the first dose of study drug had major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose of study drug, or required elective surgery during the trial.
  • Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥2
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  • Previous grade 3 or higher neurological related adverse reactions with anti-microtubule drugs.
  • Severe allergy to castor oil, or serious adverse effects from previous use of anti-microtubule drugs Those with severe allergy to castor oil or those who have experienced serious adverse reactions to previous anti-microtubule drugs.
  • Patients who are pregnant (positive result from the pregnancy test) or lactating.
  • Patients whose prior adverse reactions to anti-tumor therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicity such as alopecia which poses no safety risk in the judgment of the investigator).
  • Patients with symptomatic CNS metastases or meningeal metastases, or uncontrollable metastases.
  • Patients with an active infection that currently requires systemic anti-infective therapy, including but not limited to: HIV, active hepatitis B/C infection.
  • Patients with history of severe cardiovascular disease
  • Patients with mental disorders or poor compliance.
  • Subjects who, in the opinion of the investigator, have a history of other serious systemic diseases, or other reasons that make participation in this trial inadvisable.

Trial locations and contacts

3 sites in 1 country.

Lin Shen, MD contact

008688196561

shenlin@bjmu.edu.cn

Yanshuo Cao, MD contact

008688196561

yanshuo.cao@bjmu.edu.cn

China3 sites, 3 recruiting

  • Beijing Cancer Hospital, Beijing, China

    Beijing

    Lin Shen, MD, 008688196561, shenlin@bjmu.edu.cn

    Yanshuo Cao, MD, 008688196561, yanshuo.cao@bjmu.edu.cn

    Recruiting

  • Suining Central Hospital

    Suining, Sichuan, 629000

    Na Li, MD, 19911866118, lny.yl@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Weihui, Henan, 453100

    Yinghua Ji, MD, 0373-4402293, 54234317@qq.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Multicenter, Single-arm, Exploratory Clinical Study of Utidelone Combined With Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer That Has Failed Standard First-line Therapy

The goal of this clinical trial is to evaluate the safety, tolerance and efficacy of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who failed Standard first line therapy.

Read the detailed description

Patients with advanced or recurrent esophageal carcinoma who failed standard first-line therapy have a low survival prognosis. There are few treatment options available and the clinical need is great.

The aim of this study is to evaluate the efficacy and safety of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who fail first line therapy.

The trial is a single arm design. Patient in the treatment group will accept Utidelone at 30 mg/m2/d administered intravenously on days 1-5 and Anlotinib 8mg/d administered orally on days 1-14, 21 days as one cycle.

Before the use of utidelone, all patients will accept pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle.

Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after enrollment and will continue until disease progression according to RECIST v1.1 criteria. For patients with no disease progression, tumor evaluation will continue regardless of treatment discontinuation unless the patient begins new antitumor therapy or withdraws informed consent.

Being tested
Utidelone and anlotinib
Keywords
Esophageal Squamous Cell Carcinoma, Utidelone, Anlotinib
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Utidelone and anlotinibDrug

    Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle.

    Utidelone will be given at 30 mg/m2/d administered intravenously on days 1-5 and Anlotinib 8mg/d took orally on days 1-14 every 21 days.

Study groups in NCT05866510
Study groupRoleWhat they receive
Utidelone and AnlotinibExperimentalThe treatment group will be treated with Utidelone and Anlotinib until the presence of progressive disease or unacceptable toxicity.
Receives: Drug: Utidelone and anlotinib

What is being measured

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

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this analysis, ORR will be assessed in all participants who receive at least 1 dose of utidelone and/or anlotinib.

    Measured: Up to 1 year

Secondary outcomes (4)

  1. progression-free survival (PFS) per RECIST 1.1 in all participants

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. For this analysis, PFS will be assessed in all participants who receive at least 1 dose of utidelone and/or anlotinib.

    Measured: Up to 1 year

  2. duration of response (DOR) per RECIST 1.1 in all participants who achieve partial response (PR) or complete response (CR)

    DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.

    Measured: Up to 1 year

  3. Overall survival (OS) in all participants

    OS is defined as the time from randomization to death due to any cause. For this analysis, OS will be assessed in all participants who receive at least 1 dose of utidelone and/or anlotinib.

    Measured: Up to 2 years

  4. Incidence of Treatment-Related Adverse Events

    An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.

    Measured: Until 30 days after the last dose of treatment

Timeline

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

  1. First posted19 May 2023
  2. Study start15 May 2023 (estimated)
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Apr 2024 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05866510
Sponsor's protocol ID
2022YJZ92
Status last verified
May 2023
First submitted
7 May 2023
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Utidelone and anlotinib in people with Esophageal Cancer, run by Peking University at 3 sites 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 19 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: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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

Contact Lin Shen, MD (008688196561, shenlin@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants (time frame: Up to 1 year). 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 NCT05866510.

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 19 May 2023.

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