Esophageal squamous cell carcinoma with locally advanced middle and lower segment long lesions
Conditions
Interventions
Intervention group:Fuzheng Tongge prescription of traditional Chinese medicine decoction+Chemotherapy combined with immunotherapy
Control group:Chemotherapy combined with immunotherapy
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Between 18 and 80 years old, male or female; 2.Histologically confirmed locally advanced esophageal squamous cell carcinoma with clinical stages of cT1b-cT2N+M0 or cT3-cT4aNanyM0, and suspected involvement of surrounding organs without definite cT4b; 3.The esophageal lesion was located in the middle and lower thoracic segment; 4.Electronic gastroscopy or chest CT indicated that the length of esophageal lesion was =3cm; 5.ECOG performance status of 0 or 1; 6.Have measurable lesions that meet the RECIST1.1 criteria and are suitable for surgery; 7.Expected survival =3 months; 8.The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases.Laboratory tests meet the following requirements: a.hemoglobin (HGB)=90g/L; b. White blood cell (WBC)=3.0×10^9/L, neutrophil count (NEUT)=1.5x10^9/L; c. Platelet count (PLT)=100x10^9/L; d. Serum creatinine (SCr)=1.5x normal upper limit (ULN) or creatinine clearance=50ml/min (Cockcroft-Gault formula); e. Total bilirubin (TBIL)=1.5×ULN; f. The level of glutamic oxaloacetic transaminase (AST) or glutamic pyruvic transaminase (ALT)=2.5×ULN; g. Urinary protein 60%, FEV1 > 1.2L, FEV1% > 40%, DLco > 40%) can tolerate esophagectomy; 11.Fertile female subjects are required to undergo a blood pregnancy test within 72 hours before the first use of the drug, and the results are negative, and they voluntarily use appropriate methods of contraception during the observation period and within 120 days after the last administration of the trial drug; for males, appropriate methods of contraception should be sterilized or agreed to use appropriate methods of contraception during the observation period and within 120 days after the last administration of the trial drug. 12.The subjects voluntarily joined the study and signed the informed consent form (ICF). 13.Those with good compliance were expected to be able to follow up the efficacy and adverse reactions according to the requirements of the regimen.
Exclusion criteria
Exclusion criteria: 1.Subjects who have received or are receiving chemotherapy, radiotherapy, targeting or immunotherapy; 2.Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, etc.). The exceptions are as follows: vitiligo and psoriasis that do not require systematic treatment in the past 2 years, hypothyroidism who only need thyroid hormone replacement therapy and type I diabetes patients who only need insulin replacement therapy can be included; 3.Subjects are treated with bronchodilators and other systematic treatment, asthma control is not satisfactory, can not be included (asthma has been completely relieved in childhood, adults can be included without any intervention); 4.Suffer from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500IU / ml), hepatitis C (hepatitis C antibody positive and HCV-RNA is higher than the lower limit of detection by analytical method) or co-infection of hepatitis B and hepatitis C; 5.Immunosuppressive drugs were used within 14 days before the first use of research drugs, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., corticosteroids not exceeding the physiological dose of 10mg/ or other corticosteroids of the same physiological dose); 6.Live attenuated vaccines were given within 4 weeks before the first administration or during the study period; 7.Patients with hypertension who could not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure = 140mmHg/ diastolic blood pressure = 90 mmHg); 8.Subjects with uncontrolled cardiac clinical symptoms or diseases, such as: a.NYHAII and above heart failure; b.Unstable angina pectoris; c.Had a myocardial infarction within 1 year; d.Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention 9.Severe infection within 4 weeks before the first administration (e.g., intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5 ? during screening / before first administration; 10.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11.Pregnant or lactating women; fertile subjects unwilling or unable to use effective contraceptive measures. 12.Complicated with active second primary malignant tumor other than esophageal cancer (except skin malignant tumor); 13.Subjects with brain metastasis; 14.Those who are known to have a history of allergy to the drug components of this regimen; 15.Other conditions that the researchers believe are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mPR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR rate;pT0 mate;1-year recurrence-free survival rate;1-year survival rate;Incidence of perioperative complications;Incidence of treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactYanni Lou
China-Japan Friendship Hospital
Outcome results
None listed