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

Sponsor
Peking University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05818982
Collaborator
(none)
72
Enrollment
3
Locations
2
Arms
35.7
Anticipated Duration (Months)
24
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 9, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort A

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

Drug: Afatinib
Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.
Active Comparator: Cohort B

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

Drug: Irinotecan
Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [2 years]

    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

  1. Objective response rate [2 years]

    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.

  2. Disease control rate [2 years]

    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.

  3. Overall survival [2 years]

    OS is defined as the time from the first dose to the date of death due to any cause.

  4. Adverse Events [2 years]

    Incidence and severity of adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Agree to participate and sign the informed consent form in writing;

  2. Age: 18-75 years old;

  3. No gender limit;

  4. Esophageal squamous cell carcinoma diagnosed by pathology;

  5. The results of 3-gene RNA sequencing (ALTRK) in tumor tissue were negative;

  6. Imagingly confirmed unresectable advanced esophageal squamous cell carcinoma;

  7. Failure of previous platinum-containing regimens and immunotherapy regimens (PD-1/PD-L1 monoclonal antibody);

  8. 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;

  9. Estimated survival≥ 3 months;

  10. General Physical Condition (ECOG) 0-1;

  11. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥ 9 g/dL, white blood cell ≥ 3.0×109/L, neutrophil ≥1.5×109/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:

  1. Those who are currently receiving other effective programs;

  2. Patients who have participated in other clinical trials within 4 weeks before enrollment;

  3. There is no measurable tumor foci, such as fluid accumulation in the body cavity or diffuse infiltration of organs;

  4. Those who have received radiotherapy for measurable lesions;

  5. Previous anti-EGFR monoclonal antibody or EGFR-TKI treatment;

  6. 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;

  7. 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;

  8. Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastases;

  9. Active severe clinical infection (grade >2 NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active TB;

  10. Known or reported HIV infection or active hepatitis B or C;

  11. Uncontrolled systemic diseases, such as poorly controlled diabetes;

  12. History of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest x-ray/CT;

  13. Keratitis, ulcerative keratitis or severe dry eye;

  14. Known hypersensitivity or anaphylaxis to any component of the investigational drug;

  15. Pregnancy (determined by serum β-chorionic gonadotropin test) or breastfeeding;

  16. 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital, Beijing, China Beijing China
2 First Hospital of Xiamen University Affiliated Hospital,Xiamen,China Xiamen China
3 Xinxiang Central Hospital of Henan Province, Xinxiang, China Xinxiang China

Sponsors and Collaborators

  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shen Lin, Professor, Peking University
ClinicalTrials.gov Identifier:
NCT05818982
Other Study ID Numbers:
  • ESCC-ALTRK
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Esophageal Squamous Cell Carcinoma
Irinotecan
Afatinib

Study Results

No Results Posted as of Apr 19, 2023