locally advanced solid tumor
Conditions
Interventions
experimental group: immunotherapy combined with paclitaxel polymer micelles and platinum
Sponsors
Beidahuang Group General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1: Patients with locally advanced solid tumors (driver gene-negative non-squamous NSCLC, squamous NSCLC, cervical cancer, esophageal cancer, head and neck cancer, gastric cancer, etc.) 2: Never received immunotherapy before 3: Never used paclitaxel chemotherapy drugs before 4: Have measurable tumor lesions (spiral CT scan = 10mm, meet RECIST 1.1 standard) 5: Expected survival time = 3 months 6: Age: =18 years old, male or female 7: ECOG PS: 0-2 8: The functions of vital organs meet the following requirements: a) Absolute neutrophil count =1.5×109/L, platelet =100×109/L, hemoglobin =9g/dL;b) Bilirubin = 1.5 times ULN (patients drained by retrograde technique can be included)ALT and AST = 5 times ULN;c) Creatinine 60 mL/min 9: Women of childbearing potential must have a negative pregnancy test before starting treatment, Women and men of childbearing age must agree to uninterrupted use of effective contraception during treatment and for 6 months after the last treatment dose 10: Patients voluntarily participated in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1: Suffering from other malignant tumors in the past or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix 2: Have active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to treatment, even if treated, should be excluded. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago are also excluded, unless it is proved that they have received standard anti-tuberculosis treatment before 3: Patients with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive impairment 4: Suffering from active, known or suspected autoimmune disease. Subjects with hypothyroidism who only need hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) can be enrolled 5: Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months 6: Patients who cannot comply with the trial protocol or cannot cooperate with follow-up 7: History of psychotropic substance abuse, alcoholism or drug abuse 8: Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive 9: The researchers think that it is not suitable to participate in this experiment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression-free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactGao Feng
Beidahuang Group General Hospital
Outcome results
None listed