search
Back to results

Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Utidelone and anlotinib
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal Squamous Cell Carcinoma, Utidelone, Anlotinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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.

Sites / Locations

  • The First Affiliated Hospital of Xinxiang Medical University
  • Suining Central Hospital
  • Beijing Cancer Hospital, Beijing, ChinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Utidelone and Anlotinib

Arm Description

The treatment group will be treated with Utidelone and Anlotinib until the presence of progressive disease or unacceptable toxicity.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
May 7, 2023
Last Updated
May 10, 2023
Sponsor
Peking University
Collaborators
Beijing Biostar Pharmaceuticals Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05866510
Brief Title
Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University
Collaborators
Beijing Biostar Pharmaceuticals Co., Ltd., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Esophageal Squamous Cell Carcinoma, Utidelone, Anlotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Utidelone and Anlotinib
Arm Type
Experimental
Arm Description
The treatment group will be treated with Utidelone and Anlotinib until the presence of progressive disease or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Utidelone and anlotinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
progression-free survival (PFS) per RECIST 1.1 in all participants
Description
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.
Time Frame
Up to 1 year
Title
duration of response (DOR) per RECIST 1.1 in all participants who achieve partial response (PR) or complete response (CR)
Description
DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.
Time Frame
Up to 1 year
Title
Overall survival (OS) in all participants
Description
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.
Time Frame
Up to 2 years
Title
Incidence of Treatment-Related Adverse Events
Description
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.
Time Frame
Until 30 days after the last dose of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, MD
Phone
008688196561
Email
shenlin@bjmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yanshuo Cao, MD
Phone
008688196561
Email
yanshuo.cao@bjmu.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Weihui
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinghua Ji, MD
Phone
0373-4402293
Email
54234317@qq.com
Facility Name
Suining Central Hospital
City
Suining
State/Province
Sichuan
ZIP/Postal Code
629000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Li, MD
Phone
19911866118
Email
lny.yl@163.com
Facility Name
Beijing Cancer Hospital, Beijing, China
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Phone
008688196561
Email
shenlin@bjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanshuo Cao, MD
Phone
008688196561
Email
yanshuo.cao@bjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer

We'll reach out to this number within 24 hrs