Non-small-cell lung cancer
Conditions
Interventions
combined heat therapy group:Deep Thermal Therapy for Tumours+chemotherapy+Immune checkpoint inhibitors
control group:chemotherapy+Immune checkpoint inhibitors
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Subjects volunteered to participate and signed an informed consent form (ICF) and were able to comply with the study procedures; (2) Age =18 years old at the time of enrolment, both male and female; (3) Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC that cannot be completely resected surgically and cannot be treated with radical synchronous/sequential radiotherapy (American Cancer Consortium [AJCC] 8th edition); (4) No EGFR-sensitive mutations or ALK gene translocation alterations. For non-squamous NSCLC subjects, a report of prior histological biopsy-based testing for EGFR and ALK must be available. For squamous NSCLC subjects, if prior EGFR and ALK status is unknown, appropriate testing prior to enrolment in this study is not required and is considered negative; (5) Tissue PD-L1 expression level can be detected; (6) Expected survival time = 3 months; detectable tissue PD-L1 expression level; (7) At least one measurable lesion according to RECIST v1.1 in the opinion of the investigator; (8) Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1; (9) No prior systemic therapy for advanced or metastatic NSCLC; inclusion is permitted if: (i) in subjects with prior adjuvant or neoadjuvant chemotherapy, the last dose of prior chemotherapy was administered at least 6 months prior to signing the ICF; (ii) in subjects with locally advanced NSCLC who have received prior radical radiotherapy, the last use of chemotherapy or radiotherapy, whichever occurs, occurred at least 6 months prior to signing the ICF; and (iii) if the patient's disease has not progressed to the next stage of treatment, the patient must have been treated at least 6 months prior to signing the ICF. ICF at least 6 months prior to signing the ICF; (10) Adequate organ function prior to the first dose of study treatment (no blood components, leukocyte-boosting drugs, or platelet-boosting drugs are allowed within 14 days prior to randomisation): ? Absolute neutrophil count = 1.5 × 109 /L; ? Platelet count =100×109 /L; ? Haemoglobin =90 g/L; Serum creatinine =1.5 × upper limit of normal (ULN) or creatinine clearance (CLcr) =50 mL/min calculated by Cockcroft-Gault formula (see Appendix 3); ? Total bilirubin = 1.5 x ULN (= 3 x ULN in patients with Gilbert's syndrome); (6) AST and ALT =2.5×ULN (=5×ULN for patients with liver metastases); (vii) International Normalised Ratio (INR) or Activated Partial Thromboplastin Time (APTT) = 1.5 x ULN, unless the subject is receiving anticoagulant therapy; (8) Cardiac left ventricular ejection fraction (LVEF) = 50%; (11) Subjects (both female and male) agree to use effective contraception from the time of signing the ICF until 180 days after the last dose. Female patients of childbearing age must have a negative blood or urine pregnancy test within 14 days prior to enrolment, and must not be pregnant within 6 months of signing the ICF and the last dose of the drug.
Exclusion criteria
Exclusion criteria: (1) Contraindications to thermotherapy: cardiovascular insufficiency, patients with implanted pacemakers and metal prostheses, bleeding disorders and bleeding tendency, neurogenic bladder dysregulation, patients with perceptual disorders, patients with a body temperature of more than 38 ?, pregnant women, patients with tuberculosis in the active stage, and diseases caused by various types of stones (cholelithiasis, bladder stones, etc.). (2) Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Notes: (i) Subjects with reduced thyroid function that can be controlled only by hormone replacement therapy may be included; (ii) Subjects with dermatological conditions that do not require systemic therapy such as vitiligo, psoriasis, alopecia areata, type 1 diabetes mellitus, or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; (iii) Asthmatics requiring medical intervention with bronchodilators cannot be included. (3) Active central nervous system (CNS) metastases or carcinomatous meningitis known or symptomatic in the screening period; Notes: (i) Symptomatic CNS metastases prior to the first dose may be included if they have been treated and stable for =4 weeks and have been off systemic hormone (any dose) therapy for >3 days. (ii) Asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroids, and no lesions >1.5 cm) may be enrolled, but will require regular brain imaging as a disease site. (4) Any other form of anti-tumour therapy is expected to be required during the study period; (5) Received a proprietary medicine with an anti-tumour indication or an immunomodulatory drug (including, but not limited to, thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first dose; (6) Human immunodeficiency virus (HIV) antibody-positive patients; syphilis spirochete antibody-positive patients (syphilis spirochete-specific antibody-positive need to add non-specific antibodies, non-specific antibody-negative subjects can be included in the screening); (7) Uncontrolled active hepatitis B (defined as a positive hepatitis B surface antigen [HBsAg] test result during the screening period and an HBV-DNA test value higher than the upper limit of the normal value in the laboratory; an HBV-DNA level of less than 500 IU/mL measured within 28 days prior to randomisation; and subjects who have been receiving antiviral treatment for at least 4 weeks according to the local standard and who are willing to continue to receive antiviral treatment for the duration of the study). (Subjects on treatment may be enrolled); subjects with active hepatitis C (defined as a positive hepatitis C virus surface antibody [HCsAb] test result and HCV-RNA positivity during the screening period). (8) Currently participating in treatment in an interventional clinical study or receiving any other experimental drug or investigational device within 4 weeks prior to the first treatment (those who have failed to participate in a screening clinical trial may be included in this study); (9) Patients with a known history of psychotropic substance abuse, alcoholism, or drug addiction; previous history of definite neurological or psychiatric disorders,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;objective response rate;disease control rate;safety; | — |
Countries
China
Contacts
Public ContactZhuchen Yan
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed