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Randomized, open clinical study for NK cells combined with chemotherapy in the treatment of NSCLC with malignant pleural effusion

Randomized, open clinical study for NK cells combined with chemotherapy in the treatment of NSCLC with malignant pleural effusion

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023235
Enrollment
Unknown
Registered
2019-05-17
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-05-27

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

Conditions

NSCLC with malignant pleural effusion

Interventions

Treatment Group:NK immune cells combined with chemotherapy
Control group:chemotherapy

Sponsors

Shanghai Sixth People Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At least one measurable lesion, the diameter of the spiral CT scan was 10mm, and the diameter of the ordinary CT scan was 20 mm. 2. ECOG PS 0 and 1; Aged 18-70 years; 3. The expected survival time is > for three months. 4. Cardiac, hepatic, renal and hematopoietic functions were normal before chemotherapy. 5. Laboratory indicators must meet the following requirements: Blood: WBC > 4.0x10^9/L, neutrophil > 1.50x10^9/L, PLT count > 100x10^9/L, Hb > 95g/L; Liver function: serum bilirubin was 1.5 times lower than the maximum normal value, ALT and AST were 1.5 times lower than the maximum normal value; Renal function: serum electrolyte, urea nitrogen and creatinine were all in the normal range.

Exclusion criteria

Exclusion criteria: 1. Pathological types and clinical stages that did not meet the inclusion criteria; 2. Previous chemotherapy or targeted therapy; 3. Receiving other cancer treatment; 4. Patients with any acute or chronic disease or mental disorder or abnormal laboratory examination may increase the risk of participating in the study or study drug use, or affect the study results, and the researchers have determined that patients are not suitable for the study. 1) Uncontrolled hypertension, unstable angina, history of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmias in the past 12 months, active ischemic mucosal disease; 2) Electrocardiogram indicated ischemic changes or clinically diagnosed heart valve disease; 3) Grade III or above peripheral neuropathy; 4) The active period of a bacterial, fungal, or viral infection; 5) Pregnant or lactating women; 6) Having a history of uncontrollable mental illness; 5. Unable to terminate the use of nsaids; 6. Patients with a history of other active malignancies other than small cell lung cancer before enrollment, except for non-melanoma skin cancer, in-situ cervical cancer and early cured prostate cancer; 7. Patients with allergy constitution and known or suspected allergy to any research drugs; 8. Patients with poor compliance; 9. Brain metastases with clinical symptoms (patients with clinically stable and asymptomatic brain metastases without treatment can be enrolled); 10. Peritoneal or pericardial effusion requiring treatment; 11. Accompanied by II degrees or higher diarrhea; 12. Participating in other clinical trials within the first month before randomization.

Design outcomes

Primary

MeasureTime frame
Measurement of target lesions;

Countries

China

Contacts

Public ContactRen Tao

Shanghai Sixth People Hospital

rentao305@163.com+86 18930177191

Outcome results

None listed

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