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Camrelizumab combined with chemotherapy neoadjuvant treatment of lung cancer: an exploring, single arm phase II study

Camrelizumab combined with chemotherapy neoadjuvant treatment of lung cancer: an exploring, single arm phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054697
Enrollment
Unknown
Registered
2021-12-24
Start date
2021-12-24
Completion date
Unknown
Last updated
2022-12-05

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

Conditions

Lung cancer

Interventions

Experimental group:Camrelizumab Pearl combined with platinum double drug 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. Immissible non-small cell lung cancer diagnosed by pathogenesis or clinical diagnosis, imaging is stage IIIA-IIIB (IIIB only T3N2M0); 2. Previous surgery, radiotherapy, systematic treatment, immunotherapy; 3. With measurable tumor lesions (spiral CT scan >=10mm to meet the RECIST 1.1 standard); 4. Expected Survival> 3 months; 5. Aged 18 to 70 years, male or female; 6. ECOG PS: 0-2 points; 7. The function of important organs meets the following requirements: a) Neutral granulocytes absolute count >= 1.5x10^9 / L, platelet >= 100 x 10^9 / L, hemoglobin >=9g / dl; b) Bilirubin 35 g / ml, prothrombin prolonged period of 60 mL / min; 8. Urinary routine: Urinary routine detection showed that patients with uterin (UPRO) (UPRO) (UPRO) <2+ or 24-hour urine protein can be incorporated. 9. Women in childbearing age must carry out negative pregnancy tests (ßHCG), children's women and men (sexual relationship with childbearing age) must be agreed 6 months after treatment during treatment and last treatment dose. Contraceptive measures; 10.Patient voluntarily joined the study and signed an informed consent.

Exclusion criteria

Exclusion criteria: 1. EGFR gene mutation positive and ALK positive; 2. Conventional or other malignant tumors, but except for skin substrate cells and cervical in situ cancers; 3. Patients with bone marrow inhibit patients or patients with coagulation mechanisms and have renal dysfunction; 4. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year before the medication, even if it has been treated, it is also necessary to exclude. Patients with a history of active tuberculosis infection in more than one year have also been excluded unless it is proven to have a normative anti-tuberculosis treatment; 5. Patients with chronic infection of virus-type or hepatitis C, viral load of less than 2000 IU / mL, is allowed to participate in the study, but during research Continue or start standardize antiviral treatment. 6. Subjects that have active, known or suspicious autoimmune diseases, only the thyroid dysfunction of hormone replacement treatment, no need for skin diseases (such as vitiligo, psoriasis or hair loss) without systemic treatment Can be selected; 7. Congestive heart failure, difficult arrhythmia, myocardial infarction, unstable angina, stroke or historional ischemic attack within 6 months; 8. Patients who accept hematopoietic stem cells or organ transplantation; 9. Inoculated or subjected to vaccines within 30 days before Carrieli gabit. 10. Pregnancy or lactation women; 11. Patients who cannot follow the test scheme or cannot be followed; 12. There is a historic drug abuse, alcoholism or drug abuse; 13. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 14.Researchers believe that it is not advisable to participate in this test.

Design outcomes

Primary

MeasureTime frame
major pathological response rate;

Secondary

MeasureTime frame
pathological complete response rate;disease-free survival;objective response rate;overall survival;

Countries

China

Contacts

Public ContactXu Shidong

Affiliated Cancer Hospital of Harbin Medical University

xusd163@163.com+86 13903611962

Outcome results

None listed

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