Squamous cell lung carcinoma
Conditions
Interventions
experimental group:Immunotherapy: Cardolizumab: 6mg/kg, q2w, Intravenous infusion
Chemotherapy drugs:
Paclitaxel polymer micelles for injection: 230mg/m2 in the first cycle and 300mg/m2 in the second cycle,
Intravenous drip >= 3 hours
Carboplatin: AUC 5 mg/mL/min.
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 ~ 75 years old; 2. Histologically or cytologically confirmed squamous cell lung cancer; 3. Have not previously received local therapy (surgery or radiotherapy) against the tumor and any previous systemic anti-tumor therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, Chinese medicine therapy and any other investigational drug therapy; 4. Patients with unresectable stage III lung cancer (according to TNM stage of AJCC 9th edition, T1-4N2-3M0) after MDT evaluation; 5. Chest enhanced CT or PET/CT showing at least one measurable lesion according to RECIST v1.1; 6. ECOG score: 0 or 1; 7. The patient can tolerate conversion therapy and surgery. Radical surgical resection and systematic lymph node dissection are recommended under the condition that the surgical margin is guaranteed and the general condition of the patient is comprehensively considered. 8. Expected survival >=12 months; 9. Vital organs and bone marrow function meet the following requirements: Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors) : a) Hematological indexes: neutrophils absolute value >=1.5×10^9/L, platelets >=100×10^9/L, hemoglobin >=90g/L; b) Liver and kidney function indexes: total bilirubin =60mL/min; Urine protein is less than 2+ for routine urine examination. If the patient has urine protein >=2+ at baseline level, 24-hour urine should be collected and 24-hour urine protein quantitative detection 1.0L or FEV % > 50% b) Cardiac function index: electrocardiogram (ECG) QTc interval >480msec (QTc interval calculated by Fridericia formula); 10. Women of childbearing age must have used reliable contraception or had a pregnancy test (serum or urine) within 7 days prior to enrol, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last dose of the trial drug; 11. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. There are contraindications to immunotherapy (including long-term use of hormones, history of radiation pneumonia, etc.); 2. Have a history of severe allergy to paclitaxel or docetaxel, carboplatin or its prophylactic drugs; 3. Any unstable systemic disease, including active infection, uncontrolled high blood pressure (systolic =140 mmHg or diastolic =90 mmHg, despite best medical treatment), unstable angina, angina onset within the last 3 months, liver disease, kidney disease or metabolic disease requiring medical treatment; 4. Received live vaccination within 28 days prior to treatment; 5. Had received chemoradiotherapy, targeted therapy and immunotherapy; 6. Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.); 7. Patients with active viral hepatitis B or hepatitis C, HIV patients, active tuberculosis, etc. 8. Active infections that require antimicrobial treatment (e.g., antibiotics, antiviral drugs, antifungal drugs); 9. Known history of allogeneic organ transplantation and known history of hematopoietic stem cell transplantation; 10. Patients with interstitial lung disease or previous history of interstitial pneumonia; 11. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 12. Previous or co-existing uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer; 13. Pregnant or lactating women; A fertile patient who is unwilling or unable to take effective contraceptive measures; The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical conversion rate (SCR);event-free survival (EFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;Overall survival (OS);Time to progression;Safety; | — |
Countries
China
Contacts
Public ContactXiangzhi Zhu
Jiangsu Cancer Hospital
Outcome results
None listed