Esophageal squamous cell carcinoma
Conditions
Interventions
Treatment group:Bortezomib 1.0mg/m^2 is administered subcutaneously, four times every two weeks (on days 1, 4, 8, and 11), followed by a one-week break as one treatment cycle, with two cycles before t
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age >=18 years old and <=75 years old, gender not limited; 2) Diagnosed with esophageal squamous cell carcinoma and meeting the following conditions a) Thoracic esophageal cancer with local advanced clinical stage: cT1 to cT2N+ or cT3 to cT4a of any N, M0 (AJCC 8th Edition); b) There is a potential opportunity for surgical resection treatment; c) Tissue immunofluorescence detection confirmed positive SOX2 condensates; 3) The performance status score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 to 1 point. 4) The research participants voluntarily joined this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Combined with other malignant tumors (excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc., with no evidence of recurrence within 5 years). 2) Intestinal obstruction, toxic megacolon or active stage of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis). 3) Severe diarrhea (more than 3 watery stools per day, lasting for more than one week, and unable to be controlled by medication). 4) Severe cardiopulmonary insufficiency (NYHA cardiac function grade III-IV, COPD requires continuous oxygen therapy). 5) Pregnant or lactating women (women of childbearing age must have a negative blood test for pregnancy within 7 days before enrollment). 6) Patients with moderate to severe liver function impairment 6) Those with allergic diseases, a history of severe drug allergies, or known allergies to any component in the prescription (Note: Severe allergy guidance leads to hospitalization); 7) There are contraindications for the use of bortezomib 8) Having undergone major surgery or suffered severe trauma within 4 weeks before the first administration; 9) A history of interstitial pneumonia, a history of non-infectious pneumonia, or a high suspicion of interstitial pneumonia, etc., may interfere 10) There is an active infection, or an unexplained fever occurs during the screening period or 48 hours before the first administration, or systemic antibiotics are used within one week before signing the informed consent. 11) The study participants had active hepatitis B (HBVDNA>=2000IU/ml or 104 copies /ml) or hepatitis C (positive hepatitis C antibody and HCVRNA above the detection limit of the analytical method). Or have a known history of positive human immunodeficiency virus (HIV) test or have known acquired immunodeficiency syndrome (AIDS); 12) There is a clear history of neurological or mental disorders in the past, such as epilepsy or dementia; 13) Have a clear history of drug abuse or alcohol abuse within three months; 14) Pregnant or lactating women; The study participants (and their partners) had plans to have children, had sexual behavior without contraceptive measures, or were unwilling to take appropriate contraceptive measures (such as using condoms, intrauterine devices, or partner sterilization, etc.) from the screening period to 3 months after the end of their study. 15) Having received any investigational drug within 4 weeks prior to the first use of the investigational drug, or having been enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or follow-up of an interventional clinical study; 16) Situations where the researcher deems participation unsuitable (such as mental disorders preventing the signing of informed consent, poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-related adverse events, TRAE;Main pathological remission rate, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response, pCR;R0 resection;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactYong Yuan
West China Hospital, Sichuan University
Outcome results
None listed