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Camrelizumab combined with preoperative chemotherapy in the treatment of locally advanced driver gene-negative non-small cell lung cancer: a single-arm, prospective and open clinical study

Camrelizumab combined with preoperative chemotherapy in the treatment of locally advanced driver gene-negative non-small cell lung cancer: a single-arm, prospective and open clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048144
Enrollment
Unknown
Registered
2021-07-04
Start date
2021-07-15
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Sponsors

Anyang Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, both male and female; 2. ECOG score 0~1 points; 3. Histologically confirmed non-small cell lung cancer patients with negative driver genes; 4. Resectable or potentially resectable stage IIIA and IIIB; 5. Expected survival period >= 12 weeks; 6. The main organs function normally, that is, they meet the following standards: (1) The standard of routine blood examination should meet: ANC >=1.5x10^9/L; PLT >=90x10^9/L; Hb >=90g/L; (2) Biochemical examination should meet the following standards: TBIL = 50 mL/min (CockcroftGault formula); (3) Heart color Doppler ultrasound and echocardiography: left ventricular ejection fraction (LVEF>=55%); (4) Women with QT interval (QTcF) corrected by Fridericia method of electrocardiogram <470 ms; 7. Females of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study; serum or urine pregnancy tests are negative within 7 days before the study is enrolled, and they must be non-lactating patients; men should agree to Patients who must use contraceptive measures during the study period and within 6 months after the end of the study period; 8. Volunteer to join this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to platinum or have metabolic disorders; 2. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid Hyperfunction; patients suffering from vitiligo; asthma has been completely relieved in childhood, and can be included in adults without any intervention; patients with asthma that require bronchodilators for medical intervention cannot be included); 3. Suffer from autoimmune diseases or other diseases that require systemic treatment with corticosteroids or immunosuppressive drugs (physiological corticosteroid replacement therapy that allows adrenal or pituitary insufficiency); 4. Past received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors; 5. At the same time receive anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 6. Severe heart disease or discomfort, including but not limited to the following diseases: (1)Confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (ie Mobitz II second degree atrioventricular block or third degree atrioventricular block) (3)Angina pectoris that requires anti-angina medication; (4)Clinically significant heart valve disease; (5)ECG shows transmural myocardial infarction; (6)Poor hypertension control (systolic blood pressure> 180 mmHg and/or diastolic blood pressure> 100 mmHg). 7. Those who are known to have a history of allergies to the drug components of this program; have a history of immunodeficiency, including positive HIV tests, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 8. Active or uncontrolled serious infection; 9. History of primary or acquired immunodeficiency (including allogeneic organ transplantation); 10. Pregnant or lactating female patients, female patients who are fertile and have a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and 7 months after the last study medication; 11. Known medical history of the following infections: (1)Human Immunodeficiency Virus (HIV); (2)A history of acute or chronic hepatitis B or C; (3)Live virus vaccine was vaccinated within 30 days of the planned start of treatment. Allow the use of seasonal influenza vaccines that do not contain live viruses. 12. Suffer from serious concomitant diseases or other comorbid diseases that will interfere with the planned treatment, or any other situation where the investigator believes that the patient is not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Pathological complete response rate;

Countries

China

Contacts

Public ContactZhang Weimin

Anyang Tumor Hospital

1765115491@qq.com+86 13837240928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026