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A multi-center, randomized, open label, controlled, trial for locally advanced inoperable lung squamous cell carcinoma with radiotherapy combined with EP regimen and EP combined with glycididazole sodium (Shimena)

A multi-center, randomized, open label, controlled, trial for locally advanced inoperable lung squamous cell carcinoma with radiotherapy combined with EP regimen and EP combined with glycididazole sodium (Shimena)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027354
Enrollment
Unknown
Registered
2019-11-10
Start date
2020-09-01
Completion date
Unknown
Last updated
2019-11-11

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

Conditions

Local advanced lung squamous cell carcinoma

Interventions

experimental group:radiotherapy, EP regimen combined with glycididazole sodium (Shimena)
control group: radiotherapy combined with EP regimen

Sponsors

Liaoning Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Locally advanced SCC that is pathologically confirmed (bronchoscopy, mediastinoscopy, CT-guided puncture or supraclavicular lymph nodes) surgically inoperable or patient refused surgery; 2. There are measurable lesions, aged 18 to 75 years, gender is not limited, weight loss is less than 10% within 6 months, can tolerate radiotherapy; 3. The expected life expectancy is 12 months; 4. The subject has no major organ dysfunction, blood routine, liver, kidney function and cardiac function are basically normal; 5. Physical condition WHO score 0~2 points; 6. Laboratory test indicators must meet the following requirements: blood: leukocytes > 4.0 x 10^9 / L, neutrophils more than 5 x 10^9 / L, PLT > 100 x 10^9 / L, hemoglobin > 95g / L. Liver function: TB = 1L and > 40% of normal people corresponding values; 8. The number of cycles of chemotherapy has not exceeded 4; 9. Can understand the situation of this study and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who received systemic chemotherapy for more than 5 cycles before enrollment (4 cycles are still eligible for enrollment). 2. History of malignant tumors in other areas, excluding curable non-melanoma skin cancer and cervical carcinoma in situ. 3. Pregnancy and lactation patients. 4. There is currently an infection, but the infection can be controlled after admission. 5. Uncontrollable diabetes - an optional blood glucose > 200mg% (mmmol / L), but if the patient's blood glucose > 200mg%, fasting blood glucose < 140mg% (9.17mmol / L), the patient can be included; 6. Liver and kidney dysfunction; 7. Other serious diseases, such as myocardial infarction within 6 months; 8. People with a history of mental illness that is difficult to control; 9. The investigator believes that it is not appropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Tumor SUVmax;Hypoxic zone;Radiotherapy dose;

Secondary

MeasureTime frame
Tumor volume;Tumor withdrawal rate;

Countries

China

Contacts

Public ContactTianlu Wang

Liaoning Cancer Hospital

wangtianlu126@126.com+86 18900917511

Outcome results

None listed

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