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Neoadjuvant Tislelizumab plus chemotherapy in resectable non-small-cell lung cancer: an single-center, single-arm, phase 2 trial

Neoadjuvant Tislelizumab plus chemotherapy in resectable non-small-cell lung cancer: an single-center, single-arm, phase 2 trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062945
Enrollment
Unknown
Registered
2022-08-24
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

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

Neoadjuvant Tislelizumab plus chemotherapy group:Nil

Sponsors

Lanzhou University Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Male or female, 18 years old or above, 75 years old or below; 3. Patients who have been diagnosed with non-small cell lung cancer after biopsy of the primary tumor; 4. Patients deemed operable and requiring neoadjuvant therapy by imaging and electronic bronchoscopy, stage II - III B (according to AJCC Version 8 / International Union against Cancer NSCLC Staging System definition); 5. Cardiopulmonary function was good, and surgical resection was confirmed for radical treatment purposes; 6. According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one imaging measurable lesion; 7. The patient has not received any anti-tumor therapy in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.; 8. ECOG score 0-1 points; 9. Sufficient organ function

Exclusion criteria

Exclusion criteria: 1.Patients who have been diagnosed with other malignant tumors and have not been cured within 5 years before the first administration; 2. Patients with ALK rearrangement and EGFR mutations; 3. Currently participating in interventional clinical research and treatment; 4. Received Chinese patent medicine with anti-tumor indications or systemic systemic treatment with immunomodulatory drugs within 2 weeks before the first administration; 5. An active autoimmune disease requiring systemic treatment occurred within 2 years before the first administration. 6. Are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the study; 7. Known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Those who are known to be allergic to the active ingredients or excipients of Tirelizumab; 9. Before starting treatment, have not fully recovered from the toxicity and/or complications caused by any intervention; 10. Known infectious diseases and family medical history; 11. Pregnant or lactating women; 12. There are any serious or uncontrollable systemic diseases; 13. The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subject from participating in the study, or the investigator believes that it is not suitable for inclusion in the group. The investigator believes that there are other potential risks and is not suitable for participation this research

Design outcomes

Primary

MeasureTime frame
Pathologic complete response rate;Main pathological remission rate;

Secondary

MeasureTime frame
Relapse free survival;Overall survival;

Countries

China

Contacts

Public ContactLi Bin
dr.leebin@outlook.com13893112658

Outcome results

None listed

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