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Efficacy and safety of albumin-bound paclitaxel combined with cisplatin for neoadjuvant chemotherapy in squamous non-small cell lung cancer

Efficacy and safety of albumin-bound paclitaxel combined with cisplatin for neoadjuvant chemotherapy in squamous non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024720
Enrollment
Unknown
Registered
2019-07-24
Start date
2019-08-23
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Squamous non-small cell lung cancer

Interventions

experiment group:albumin-bound paclitaxel combined with cisplatin

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Men and women, >=18 years of age; 2. Histologically or cytologically confirmed tissue type squamous cell carcinoma; 3. Surgically resectable NSCLC of IB-IIIB; 4. Patients who have not previously received initial treatment for chemotherapy or radiation therapy; 5. ECOG score = 3 months; 7. Subjects of childbearing age must agree to take effective contraceptive measures during the trial; The serum or urine pregnancy test for women of childbearing age 72 hours before the start must be negative; 8. Subjects are well compliant, able to undergo treatment and follow-up, and voluntarily comply with the study; 9. Subjects voluntarily signed informed consent.

Exclusion criteria

Exclusion criteria: 1. N3 or M1; 2. There are uncontrolled serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, uncontrolled infection, active peptic ulcer, etc.; 3. Dementia, mental state changes, or any mental illness that interferes with understanding or making informed consent or completing a questionnaire; 4. Subjects with >= 2 peripheral neuropathy according to CTCAE V5.0; 5. A history of allergies or hypersensitivity reactions to any of the therapeutic ingredients; 6. Have a malignant tumor other than NSCLC in the past 5 years, except for adequately treated basal cells or squamous cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery ; 7. Physical examination and laboratory test results are abnormal: a) Hematological dysfunction is defined as: i) Neutrophil absolute count: 1.5 times the upper limit of normal (ULN); ii) Aspartate aminotransferase and alanine aminotransferase > 2.5 times ULN; c) Renal dysfunction: serum creatinine > 1.5 times ULN, or calculated creatinine clearance < 50ml / min; 8.Combine other anti-cancer drug treatments; 9. Have received any other test drug treatment or participated in another interventional clinical trial within 30 days prior to screening; 10. The investigator believes that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Postoperative pathological complete response rate;

Secondary

MeasureTime frame
Objective response rate;Surgical complete resection rate;safety;

Countries

China

Contacts

Public ContactYue Yang

Department of Thoracic Surgery II, Beijing Cancer Hospital

zlyangyue@bjmu.edu.cn+86 010-88196568

Outcome results

None listed

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