Last updated: April 6, 2023
Sponsor: Peking University
Overall Status: Active - Recruiting
Phase
2
Condition
Esophageal Disorders
Squamous Cell Carcinoma
Esophageal Cancer
Treatment
N/AClinical Study ID
NCT05818982
ESCC-ALTRK
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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-measurablelesion 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; 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:
- Those who are currently receiving other effective programs;
- Patients who have participated in other clinical trials within 4 weeks beforeenrollment;
- There is no measurable tumor foci, such as fluid accumulation in the body cavity ordiffuse 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 sametime, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- 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;
- Neurological or psychiatric abnormalities affecting cognitive ability, includingcentral nervous system metastases;
- Active severe clinical infection (grade >2 NCI-CTCAE version 5.0) within 14 days priorto 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, pulmonaryfibrosis, 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;
- 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
Connect with a study center
Beijing Cancer Hospital, Beijing, China
Beijing,
ChinaActive - Recruiting
First Hospital of Xiamen University Affiliated Hospital,Xiamen,China
Xiamen,
ChinaSite Not Available
Xinxiang Central Hospital of Henan Province, Xinxiang, China
Xinxiang,
ChinaSite Not Available
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