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

NCT05818982 | Recruiting Phase 2

• 1 other identifier: ESCC-ALTRK
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (4)

• Objective response rate

  2 years

• Disease control rate

  2 years

• Overall survival

  2 years

• Adverse Events

  2 years

Study Arms (2)

Cohort A

EXPERIMENTAL

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

Drug: Afatinib

Cohort B

ACTIVE COMPARATOR

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

Drug: Irinotecan

Interventions

Afatinib DRUG

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

Cohort A

Irinotecan DRUG

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

Cohort B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University: lead

Study Sites (3)

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

MeSH Terms

Interventions

Afatinib; Irinotecan

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Central Study Contacts

Lin Shen, MD

CONTACT

+86-10-88196561; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: February 9, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)