Evaluating Afatinib for Advanced Esophageal Cancer

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

This study is testing if a new drug called afatinib can help people with advanced esophageal cancer feel better compared to a standard treatment called irinotecan.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University (Academic / other)
• Drugs / interventions: immunotherapy, Afininib, afatinib
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT05818982 on ClinicalTrials.gov

What this trial studies

This phase II study aims to assess the efficacy and safety of afatinib compared to irinotecan in patients with advanced esophageal squamous cell carcinoma that is negative for ALTRK gene alterations. Participants will be randomly assigned to receive either afatinib daily or irinotecan biweekly. The study will measure treatment effectiveness based on tumor response and safety profiles. The goal is to provide a potential new treatment option for patients who have not responded to previous therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with unresectable advanced esophageal squamous cell carcinoma that is ALTRK-negative and who have failed prior treatments.

Not a fit: Patients with resectable tumors or those who have not failed previous platinum-containing or immunotherapy regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients with advanced esophageal squamous cell carcinoma.

How similar studies have performed: Other studies have shown promising results with similar targeted therapies in advanced esophageal cancer, suggesting potential for success in this approach.

Eligibility criteria

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 ≥ 3.0×10\^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:

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;

Where this trial is running

Beijing and 2 other locations

• Beijing Cancer Hospital, Beijing, China — Beijing, China (Recruiting)
• First Hospital of Xiamen University Affiliated Hospital,Xiamen,China — Xiamen, China (Not_yet_recruiting)
• Xinxiang Central Hospital of Henan Province, Xinxiang, China — Xinxiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Lin Shen, MD

Conditions Advanced Esophageal Squamous Cell Carcinoma