Status:
UNKNOWN
Utidelone in Third-line and Above Treatment of Small Cell Lung Cancer
Lead Sponsor:
Henan Cancer Hospital
Conditions:
SCLC, Extensive Stage
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
SCLC has a very high degree of malignancy, and 60% to 70% of patients are diagnosed as extensive stage. The median survival of patients with limited-stage disease is about 15-20 months, and the median...
Detailed Description
Compared with paclitaxel, epothilones has higher water solubility and toxicity tolerance, and fewer side effects, these findings suggest that utidron may have better antitumor activity against small c...
Eligibility Criteria
Inclusion
- Histologically diagnosed small cell lung cancer (except for small cell lung cancer mixed with other pathological types);
- The expected survival period is not less than 3 months;
- Second-line therapy (excluding maintenance therapy) and above with disease progression or recurrence of small cell lung cancer;
- Patients who have not received chemotherapy, radiotherapy, surgery, targeted therapy and immunotherapy within 4 weeks before enrollment;
- Age 18-75 years old, physical condition score ECOG 0-1 points;
- At least one target lesion measurable by imaging within 3 weeks before enrollment, ordinary CT scan ≥ 20 mm, spiral CT scan diameter ≥ 10 mm (lymph node short diameter ≥ 15 mm);
- Asymptomatic brain metastases, or patients with stable disease for more than 4 weeks after brain metastases treatment;
- Neurological lesions should be less than grade 2 within 4 weeks before enrollment (NCI CTC4.03);
- Routine blood and blood biochemical tests were basically normal within 1 week before enrollment (based on the normal value of the research center laboratory, no blood transfusion within 14 days before screening, and no rhG-CSF was used):
- Blood routine: HGB≥9g/dL; ANC≥1.5×109/L; PLT≥80×109/L; Blood biochemistry (without ALB infusion within 14 days): bilirubin \<1.5 times the upper limit of normal, ALT and AST ≤2.5 times the upper limit of normal (if liver metastases exist, bilirubin ≤3 times the upper limit of normal, ALT and AST≤3 times the upper limit of normal) 5 times the upper limit of normal), serum Cr≤1.5 times the upper limit of normal or endogenous creatinine clearance ≥45 mL/min (Cockcroft-Gault formula);
- Those who have no major organ dysfunction and no concomitant heart disease;
- Females of childbearing age, including those who are in menopause but have not reached postmenopausal state (natural amenorrhea for 12 consecutive months) and who have not received sterilization and ovarian and/or hysterectomy, must have a blood pregnancy test within 7 days before the first
Exclusion
- Pregnancy (positive pregnancy test) or lactating patients;
- Patients with active pulmonary tuberculosis;
- Patients with high suspicion of interstitial lung disease;
- Exclusion criteria for combined diseases:
- Cancerous meningitis patients;
- patients with symptomatic central nervous system (CNS) metastasis;
- Other active malignant tumors that require concurrent treatment, but not including carcinoma in situ of the cervix or basal cell carcinoma of the skin;
- Patients with serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infection, active peptic ulcer, and those with a history of mental illness that is not easy to control;
- HIV positive test results, untreated active hepatitis patients;
- Patients with poor compliance; The investigators believe that those who are not suitable to participate in this trial.
Key Trial Info
Start Date :
September 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 5 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05299255
Start Date
September 5 2021
End Date
September 5 2023
Last Update
March 28 2022
Active Locations (1)
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1
Henan Tumor Hospital
Zhengzhou, Henan, China, 450000