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A single-arm, prospective, exploratory clinical study of carrelizumab combined with platinum-containing dual-drug chemotherapy in neoadjuvant treatment of stage II-IIIA resectable squamous non-small cell lung cancer

A single-arm, prospective, exploratory clinical study of carrelizumab combined with platinum-containing dual-drug chemotherapy in neoadjuvant treatment of stage II-IIIA resectable squamous non-small cell lung cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045698
Enrollment
Unknown
Registered
2021-04-23
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-12-06

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: carrelizumab combined with platinum-containing dual-drug chemotherapy

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. Stage II-IIIA resectable squamous non-small cell lung cancer diagnosed by histopathology or cytology; 3. EGFR / ALK and other driver genes are negative; 4. Squamous non-small cell lung cancer has not received any treatment in the past; 5. The subject must have sufficient lung function to tolerate lung resection; 6. According to the RECIST 1.1 standard, the subject must have a measurable target lesion that can be examined by CT or MRI; 7. The World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) physical performance score (PS) was 0 or 1 when the patient was enrolled; 8. Life expectancy >= 3 months; 9. The patient signs an informed consent form and voluntarily joins the study; 10. There is no serious liver and kidney function damage, and the function level of the organs must meet the following requirements: ANC >= 1.5x10^9/L; PLT >= 90x10^9/L; Hb >= 90 g/L; TBIL = 50 mL/min (Cockcroft-Gault formula); LVEF >= 50%; QT interval adjusted by Fridericia method (QTcF) Male <450 ms, female <470 ms; INR <= 1.5xULN, ACTT <= 1.5xULN.

Exclusion criteria

Exclusion criteria: 1. Patients with allergies or hypersensitivity to treatment drugs, patients with autoimmune diseases; 2. There is fluid in the third space that cannot be controlled by drainage or other methods (such as large amounts of pleural fluid and ascites); 3. Use steroids for more than 50 days, or need to use steroids for a long time; 4. Uncontrolled symptomatic brain metastases or mental disorders that cannot correctly express subjective symptoms; 5. Receive any other anti-tumor treatments at the same time, including anti-tumor Chinese patent medicines and immune preparations; 6. Other malignant tumors occurred within 5 years before enrollment, except for cervical carcinoma in situ or skin squamous or basal cell carcinoma that was previously treated for the purpose of radical treatment; 7. Women who are pregnant or breastfeeding, have fertility but refuse to take contraceptive measures; 8. Have received allogeneic tissue/solid organ transplantation; 9. According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.); 10. The investigator judges other situations that are not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Main pathological remission rate;

Secondary

MeasureTime frame
Objective response rate;Pathological complete remission rate;Adverse events;

Countries

china

Contacts

Public ContactLuo Tao

Affiliated Hospital of Xuzhou Medical University

1571819567@qq.com+86 13813289319

Outcome results

None listed

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