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

Last updated: April 6, 2023
Sponsor: Peking University
Overall Status: Active - Recruiting

Phase

2

Condition

Esophageal Disorders

Squamous Cell Carcinoma

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT05818982
ESCC-ALTRK
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-measurablelesion 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 ≥ 3.0×10^9/L, neutrophil ≥1.5×10^9/L, platelet ≥ 100×10^9/L; Normalliver and kidney function (within 14 days): TBIL ≤ 1.5 times the upper limit ofnormal; ALT and AST ≤ 2.5 times the upper limit of normal, and if liver metastases arepresent, ≤ 5 times the upper limit of normal; Creatinine ≤ 1.5 times the upper limitof normal;

Exclusion

Exclusion Criteria:

  1. Those who are currently receiving other effective programs;
  2. Patients who have participated in other clinical trials within 4 weeks beforeenrollment;
  3. There is no measurable tumor foci, such as fluid accumulation in the body cavity ordiffuse 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 sametime, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
  7. Clinically significant cardiovascular diseases, such as heart failure (NYHA GRADEIII-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolledhypertension or history of myocardial infarction within the past 1 year;
  8. Neurological or psychiatric abnormalities affecting cognitive ability, includingcentral nervous system metastases;
  9. Active severe clinical infection (grade >2 NCI-CTCAE version 5.0) within 14 days priorto 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, pulmonaryfibrosis, 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 liverfunction that is not suitable for the treatment of this study;

Study Design

Total Participants: 72
Study Start date:
February 09, 2023
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Beijing Cancer Hospital, Beijing, China

    Beijing,
    China

    Active - Recruiting

  • First Hospital of Xiamen University Affiliated Hospital,Xiamen,China

    Xiamen,
    China

    Site Not Available

  • Xinxiang Central Hospital of Henan Province, Xinxiang, China

    Xinxiang,
    China

    Site Not Available

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