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Trial Title:
To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC
NCT ID:
NCT05818982
Condition:
Advanced Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Esophageal Squamous Cell Carcinoma
Irinotecan
Afatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Afatinib
Description:
Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.
Arm group label:
Cohort A
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D
Arm group label:
Cohort B
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital, Beijing, China
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen, MD
Facility:
Name:
First Hospital of Xiamen University Affiliated Hospital,Xiamen,China
Address:
City:
Xiamen
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jiayi Li
Facility:
Name:
Xinxiang Central Hospital of Henan Province, Xinxiang, China
Address:
City:
Xinxiang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yinghua Ji
Start date:
February 9, 2023
Completion date:
February 2026
Lead sponsor:
Agency:
Peking University
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05818982
