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An exploratory clinical study of camrelizumab combined with platinum-containing chemotherapy for neoadjuvant therapy in patients with non-small cell lung cancer

An exploratory clinical study of camrelizumab combined with platinum-containing chemotherapy for neoadjuvant therapy in patients with non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050246
Enrollment
Unknown
Registered
2021-08-24
Start date
2021-08-27
Completion date
Unknown
Last updated
2022-04-25

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

experimental group:camrelizumab combined with platinum-containing chemotherapy

Sponsors

Affiliated Cancer Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Potentially resectable non-small cell lung cancer diagnosed by pathology or clinical diagnosis, and the staging is IIB-IIIB (IIIB is only T3N2M0); 2. Have not received systemic treatment in the past; 3. With measurable tumor lesions (spiral CT scan >=10mm, meet the RECIST 1.1 standard); 4. Expected survival time> 3 months; 5. Aged from 18 to 70 years, no gender limit; 6. ECOG PS: 0-2 points; 7. The functions of vital organs meet the following requirements: (1) Absolute neutrophil count >=1.5x10^9/L, platelet >=100x10^9/L, hemoglobin >=9g/dL. (2) Bilirubin 60 mL/min; 8. Women of childbearing age must have a negative pregnancy test before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraception during treatment and 6 months after the last treatment dose; 9. The patient voluntarily joined the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. EGFR gene mutation positive and ALK positive; 2. Suffered from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 3. Patients with bone marrow suppression or coagulation disorders and patients with renal impairment; 4. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before the medication should be excluded even if they have been treated. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 5. Patients with active hepatitis B or C, and chronically infected patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 2000 IU/mL are allowed to participate in the study, but are required during the study period Continue or start the full course of standardized antiviral therapy; 6. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) can be selected; 7. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; 8. Patients receiving hematopoietic stem cell or organ transplantation; 9. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of camrelizumab; 10. Pregnant or lactating women; 11. Patients who cannot comply with the trial protocol or cannot cooperate with the follow-up; 12. Have a history of psychotropic drug abuse, alcohol or drug abuse; 13. Human immunodeficiency virus positive; 14. Researchers believe that it is inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Major pathological response rate;

Secondary

MeasureTime frame
pathologic complete response;disease free survival;objective remission rate;

Countries

China

Contacts

Public ContactMa Jianqun

Affiliated Cancer Hospital of Harbin Medical University

jianqunma@aliyun.com+86 13359990466

Outcome results

None listed

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