Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Using concurrent chemoradiotherapy combined with nimotuzumab followed by sequential camrelizumab treatment
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, any gender; 2. Cytologically or histologically confirmed esophageal squamous cell carcinoma; 3. No prior local treatment for the primary esophageal tumor, including surgery and radiotherapy; 4. Clinical stage: cT2-4a, N0-3, M0 (AJCC/UICC Esophageal Cancer Staging, 8th edition); 5. Primary tumor evaluable; 6. No distant organ metastasis; 7. PS score 0-1; 8. Expected survival >= 6 months; 9. Major organ functions are normal, meeting the following criteria: (1) Blood routine examination: 1) HGB >= 90 g/L; 2) ANC >= 1.5 × 10^9/L; 3) PLT >= 80 × 10^9/L; (2) Biochemical tests: 1) ALB >= 30 g/L; 2) ALT and AST = 60 ml/min; 10. Pulmonary function: FEV1/FVC >= 70%, FEV1 >= 50% of the normal value, DLCO (lung diffusion function) measured value as a percentage of the predicted value > 80%. 11. Women of childbearing age must undergo a pregnancy test within 7 days before starting treatment, and the result must be negative; 12. All enrolled patients must use adequate contraception during the entire treatment period and for 4 weeks after the end of treatment; 13. No severe hematopoietic dysfunction, cardiac dysfunction, or immune deficiency; 14. No esophageal perforation and active esophageal bleeding, no invasion of trachea or major thoracic vessels.
Exclusion criteria
Exclusion criteria: 1. Patients with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that fully resolved in childhood and does not require any intervention in adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included); 2. Patients currently using immunosuppressants or systemic corticosteroid therapy to achieve immunosuppression (dose >10 mg/day prednisone or equivalent corticosteroid), and still using them within 2 weeks prior to enrollment; 3. Patients who have previously received EGFR monoclonal antibody or EGFR tyrosine kinase inhibitor treatment; 4. Patients with any severe and/or uncontrolled diseases, including: patients with poorly controlled blood pressure (systolic >=150 mmHg or diastolic >=100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmias (including QT interval >=480 ms), and grade I heart failure; active or uncontrolled severe infections; liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >=10^4 copies/ml or 2000 IU/ml) or hepatitis C (HCV antibody positive, and HCV-RNA above the detection limit of the assay); 5. Patients whose imaging shows tumor invasion into major blood vessels, or who are judged by the investigator to have tumor highly likely to invade major blood vessels and cause fatal hemorrhage during subsequent study period; 6. Pregnant or breastfeeding women; 7. Patients with other malignancies within the past 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 8. Patients with a history of substance abuse of psychotropic drugs who cannot quit or patients with mental disorders; 9. Patients who have participated in other drug clinical trials within the past four weeks; 10. Patients with concomitant diseases that, in the investigator's judgment, pose a serious risk to patient safety or affect the completion of the study; 11. Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (progression-free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Incidence of Treatment-Related Adverse Events (TRAEs);Quality of Life (QoL); | — |
Countries
China
Contacts
Public ContactMingxia Zhang
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed