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To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC

Primary Purpose

Advanced Esophageal Squamous Cell Carcinoma

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

About this trial

This is an interventional treatment trial for Advanced Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

Inclusion Criteria: Agree to participate and sign the informed consent form in writing; Age: 18-75 years old; No gender limit; Esophageal squamous cell carcinoma diagnosed by pathology; The results of 3-gene RNA sequencing (ALTRK) in tumor tissue were negative; Imagingly confirmed unresectable advanced esophageal squamous cell carcinoma; Failure of previous platinum-containing regimens and immunotherapy regimens (PD-1/PD-L1 monoclonal antibody); At least one measurable lesion (according to RECIST1.1 criteria) or non-measurable lesion that can be evaluated, with imaging diagnosis ≤ 21 days from enrollment; Estimated survival≥ 3 months; General Physical Condition (ECOG) 0-1; Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥ 9 g/dL, white blood cell ≥ 3.0×10^9/L, neutrophil ≥1.5×10^9/L, platelet ≥ 100×10^9/L; Normal liver and kidney function (within 14 days): TBIL ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal, and if liver metastases are present, ≤ 5 times the upper limit of normal; Creatinine ≤ 1.5 times the upper limit of normal; Exclusion Criteria: Those who are currently receiving other effective programs; Patients who have participated in other clinical trials within 4 weeks before enrollment; There is no measurable tumor foci, such as fluid accumulation in the body cavity or diffuse infiltration of organs; Those who have received radiotherapy for measurable lesions; Previous anti-EGFR monoclonal antibody or EGFR-TKI treatment; Patients with other primary malignant tumors other than esophageal cancer at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; Clinically significant cardiovascular diseases, such as heart failure (NYHA GRADE III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or history of myocardial infarction within the past 1 year; Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastases; Active severe clinical infection (grade >2 NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active TB; Known or reported HIV infection or active hepatitis B or C; Uncontrolled systemic diseases, such as poorly controlled diabetes; History of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest x-ray/CT; Keratitis, ulcerative keratitis or severe dry eye; Known hypersensitivity or anaphylaxis to any component of the investigational drug; Pregnancy (determined by serum β-chorionic gonadotropin test) or breastfeeding; The investigator determines that there are abnormal heart or lung or kidney or liver function that is not suitable for the treatment of this study;

Sites / Locations

  • Beijing Cancer Hospital, Beijing, ChinaRecruiting
  • First Hospital of Xiamen University Affiliated Hospital,Xiamen,China
  • Xinxiang Central Hospital of Henan Province, Xinxiang, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cohort A

Cohort B

Arm Description

Group A received afatinib (40 mg oral/day) every 6 weeks

Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks

Outcomes

Primary Outcome Measures

Progression-free survival
PFS is defined as the time from the first dose to the date of the disease progression or death from any cause.

Secondary Outcome Measures

Objective response rate
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Disease control rate
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Overall survival
OS is defined as the time from the first dose to the date of death due to any cause.
Adverse Events
Incidence and severity of adverse events.

Full Information

First Posted
April 6, 2023
Last Updated
April 6, 2023
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT05818982
Brief Title
To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC
Official Title
A Multicenter, Open-label, Randomized, Controlled Phase II Study to Evaluate the Efficacy and Safety of Afatinib Versus Irinotecan as a Second-line and Above Treatment for Advanced ALTRK-negative ESCC
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

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
This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.
Detailed Description
Participants were assigned to either group A or group B at 2:1 randomization (block randomization). Group A received afatinib (40 mg orally/day) every 6 weeks; Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Group A received afatinib (40 mg oral/day) every 6 weeks
Arm Title
Cohort B
Arm Type
Active Comparator
Arm Description
Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Afatinib
Intervention Description
Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D
Primary Outcome Measure Information:
Title
Progression-free survival
Description
PFS is defined as the time from the first dose to the date of the disease progression or death from any cause.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective response rate
Description
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time Frame
2 years
Title
Disease control rate
Description
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Time Frame
2 years
Title
Overall survival
Description
OS is defined as the time from the first dose to the date of death due to any cause.
Time Frame
2 years
Title
Adverse Events
Description
Incidence and severity of adverse events.
Time Frame
2 years

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: Agree to participate and sign the informed consent form in writing; Age: 18-75 years old; No gender limit; Esophageal squamous cell carcinoma diagnosed by pathology; The results of 3-gene RNA sequencing (ALTRK) in tumor tissue were negative; Imagingly confirmed unresectable advanced esophageal squamous cell carcinoma; Failure of previous platinum-containing regimens and immunotherapy regimens (PD-1/PD-L1 monoclonal antibody); At least one measurable lesion (according to RECIST1.1 criteria) or non-measurable lesion that can be evaluated, with imaging diagnosis ≤ 21 days from enrollment; Estimated survival≥ 3 months; General Physical Condition (ECOG) 0-1; Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥ 9 g/dL, white blood cell ≥ 3.0×10^9/L, neutrophil ≥1.5×10^9/L, platelet ≥ 100×10^9/L; Normal liver and kidney function (within 14 days): TBIL ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal, and if liver metastases are present, ≤ 5 times the upper limit of normal; Creatinine ≤ 1.5 times the upper limit of normal; Exclusion Criteria: Those who are currently receiving other effective programs; Patients who have participated in other clinical trials within 4 weeks before enrollment; There is no measurable tumor foci, such as fluid accumulation in the body cavity or diffuse infiltration of organs; Those who have received radiotherapy for measurable lesions; Previous anti-EGFR monoclonal antibody or EGFR-TKI treatment; Patients with other primary malignant tumors other than esophageal cancer at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; Clinically significant cardiovascular diseases, such as heart failure (NYHA GRADE III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or history of myocardial infarction within the past 1 year; Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastases; Active severe clinical infection (grade >2 NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active TB; Known or reported HIV infection or active hepatitis B or C; Uncontrolled systemic diseases, such as poorly controlled diabetes; History of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest x-ray/CT; Keratitis, ulcerative keratitis or severe dry eye; Known hypersensitivity or anaphylaxis to any component of the investigational drug; Pregnancy (determined by serum β-chorionic gonadotropin test) or breastfeeding; The investigator determines that there are abnormal heart or lung or kidney or liver function that is not suitable for the treatment of this study;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, MD
Phone
+86-10-88196561
Email
linshenpku@163.com
Facility Information:
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
Facility Name
First Hospital of Xiamen University Affiliated Hospital,Xiamen,China
City
Xiamen
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayi Li
Facility Name
Xinxiang Central Hospital of Henan Province, Xinxiang, China
City
Xinxiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yinghua Ji

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC

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