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

NCT ID: NCT05818982

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2026-02-28

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.

Conditions

Advanced Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A

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

Group Type: EXPERIMENTAL

Afatinib

Intervention Type: DRUG

Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.

Cohort B

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

Group Type: ACTIVE_COMPARATOR

Irinotecan

Intervention Type: DRUG

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

Interventions

Afatinib

Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.

Intervention Type: DRUG

Irinotecan

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

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital, Beijing, China

Beijing, , China

Site Status: RECRUITING

First Hospital of Xiamen University Affiliated Hospital,Xiamen,China

Xiamen, , China

Site Status: NOT_YET_RECRUITING

Xinxiang Central Hospital of Henan Province, Xinxiang, China

Xinxiang, , China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Lin Shen, MD

Role: CONTACT

linshenpku@163.com

+86-10-88196561

Facility Contacts

Lin Shen, MD

Role: primary

Jiayi Li

Role: primary

Yinghua Ji

Role: primary

Other Identifiers

ESCC-ALTRK

Identifier Type: -

Identifier Source: org_study_id