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To evaluate the efficacy and safety of albumin paclitaxel in first-line and maintenance therapy in patients with advanced lung squamous cell carcinoma

To evaluate the efficacy and safety of albumin paclitaxel in first-line and maintenance therapy in patients with advanced lung squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034444
Enrollment
Unknown
Registered
2020-07-05
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-07-06

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:Albumin-bound paclitaxel maintenance therapy

Sponsors

Yunnan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged >=18 years; 2) Patients with stage IIIB, IIIC and IV lung squamous cell carcinoma diagnosed by histology or cytology; 3) At least one objective lesion (CT, MRI or X-ray, etc.) can be measured or evaluated by imaging examination; 4) Did not receive chemotherapy; 5) Expected survival time >=3 months; 6)ECOG physical condition score 0~1; 7) Peripheral blood was basically normal: Absolute count of neutrophils (ANC) : >=1.5x10^9/L; Platelet count (PLT): >=100x10^9/L; Hemoglobin (Hb) level >=90g/L; 8) No obvious abnormalities in cardiac, hepatic and renal function: Total bilirubin (TBil) level: <=1.5 ULN; The levels of AST and ALT were <=2.5 ULN, and <=5 ULN in the presence of liver metastasis.Serum creatinine <=1.5 ULN; Electrocardiogram was basically normal without contraindications of chemotherapy; 9) Subjects have good compliance, can conduct treatment and follow-up, and voluntarily comply with the provisions of this study; 10) Subjects of childbearing age must agree to use effective contraception during the study period;Serum or urine pregnancy tests must be negative in women of childbearing age 72 hours before chemotherapy begins;The female must be non-lactating; 11) Sign the informed consent; 12) Patients with advanced lung squamous cell carcinoma who have been denied genetic testing or who have been genetically negative. Maintain chemotherapy inclusion criteria: 1) Remission (CR+PR) was achieved 12 weeks after first-line chemotherapy without progression; 2)Physical condition can tolerate subsequent treatment, ECOG physical condition score 0~1;

Exclusion criteria

Exclusion criteria: 1) There is brain metastasis; 2) Uncontrolled severe medical conditions that the investigator believes will affect the subject's treatment with the study protocol;Dementia, change of mental state or any mental illness that would prevent understanding or informed consent or the completion of a questionnaire; 3) A history of allergy or hypersensitivity to any therapeutic ingredient; 4) Malignant tumors other than NSCLC within 5 years, except basal cell or squamous cell skin cancer that is adequately treated, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; 5) Subjects with >=2 grade peripheral neuropathy according to CTCAE V 4.03; 6) HBsAg positive subjects with peripheral blood HBV DNA titer >=1x10^3 IU/mL; 7) Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive; 8) Need to be combined with other anti-tumor drugs; 9) Has been treated with any other experimental drug or participated in another interventional clinical trial within 30 days of the screening period; 10) The researcher thinks it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Countries

China

Contacts

Public ContactLi Gaofeng

Yunnan Cancer Hospital

ligaofenghl@126.com+86 13987123539

Outcome results

None listed

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