Advanced Esophageal Squamous Cell Carcinoma
Conditions
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.
Interventions
DRUGAfatinib
Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.
DRUGIrinotecan
Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2 years | PFS is defined as the time from the first dose to the date of the disease progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 2 years | The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1. |
| Disease control rate | 2 years | Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1. |
| Overall survival | 2 years | OS is defined as the time from the first dose to the date of death due to any cause. |
| Adverse Events | 2 years | Incidence and severity of adverse events. |
Countries
China
Contacts
Primary ContactLin Shen, MD
Outcome results
None listed