Lung cancer
Conditions
Interventions
Valsartan combined with chest radiotherapy combined with immune checkpoint inhibitors:1. For the first round of chest radiotherapy combined with immunotherapy, start oral valsartan 80mg once daily. Pa
Chest radiotherapy combined with immune checkpoint inhibitors:1. Immune checkpoint inhibitor treatment is administered every 3 weeks. The dosage is calculated according to the instructions. The drugs
Sponsors
Jinan central hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age >= 18 years old, gender not restricted. 2) Pathologically confirmed lung cancer, patients in advanced stage, locally advanced stage or those who cannot undergo surgery in the early stage. 3) ECOG physical activity score 0-2. 4) Expected survival time of more than half a year. 5) Adequate organ function: expected survival period > half a year. 6) Sufficient hematopoietic function, liver and kidney function: a. Neutrophil count >= 1.5 × 10^9/L; b. White blood cell count >= 3 × 10^9/L; c. Platelet count >= 80 × 10^9/L; d. Hemoglobin >= 90 g/L; e. Creatinine <= 1.5 × ULN; f. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) <= 2.5 × ULN (for liver metastasis <= 5 × ULN); h. Total bilirubin <= 1.5 × ULN (for liver metastasis <= 3 × ULN); i. Alkaline phosphatase <= 5 × ULN. 7) Plan to receive conventional fractionated thoracic radiotherapy (single irradiation dose 1.8 - 2.2 Gy), planned irradiation dose of more than 45 Gy. 8) Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions. 9) Able to complete the study as per the trial protocol. 10) Subjects (including male subjects) have taken effective contraceptive measures within 14 days before screening and are willing to have no pregnancy plan from the time of signing the informed consent until the end of the study and voluntarily take effective contraceptive measures.y (single irradiation dose 1.8 - 2.2 Gy), planned irradiation dose of more than 45 Gy. 8) Signed the informed consent form before the trial and fully understood the trial content, process and possible adverse reactions. 9) Able to complete the study as per the trial protocol. 10) Subjects (including male subjects) have taken effective contraceptive measures within 14 days before screening and are willing to have no pregnancy plan from the time of signing the informed consent until the end of the study and voluntarily take effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1) Patients with resting blood pressure lower than 110/60 mmHg 2) Unable to take oral medications, or having conditions that, in the judgment of the investigators, severely affect gastrointestinal absorption (such as chronic diarrhea, intestinal obstruction, etc.). 3) Suffering from severe pulmonary dysfunction diseases, such as interstitial diseases, severe chronic obstructive pulmonary disease (COPD), and having contraindications for chest radiotherapy. 4) Having a history of severe cardiovascular or cerebrovascular diseases (patients with stable blood pressure control can participate, but the antihypertensive drugs must include valsartan). 5) Having contraindications for oral valsartan, such as renal artery stenosis, severe renal function impairment, etc. 6) The investigator believes that the subject has any clinical or laboratory examination abnormalities or other reasons that make them unsuitable to participate in this clinical study. 7) Has previously undergone chest radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactMeili Sun
Jinan central hospital
Outcome results
None listed