Lung adenocarcinoma
Conditions
Interventions
Treatment group :Gossypol acetate tablets combined with docetaxel and cisplatin
Control group : Docetaxel combined with cisplatin
Sponsors
Tangshan People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged above 50 and below 75; 2. Patients with histologically or cytologically confirmed lung adenocarcinoma (ns-nsclc) (according to the American joint commission on cancer); 3. At least one evaluable lung or metastatic lesion (RECIST1.1, CT scan 10 mm; WHO standard); 4. Immunohistochemical LRPPRC staining ++ or +++; 5. At the time of diagnosis, it is locally advanced and inoperable or distant metastasis has occurred; 6. For relapsed patients who have received previous treatment (including surgery, chemoradiotherapy, etc.), the time from the last treatment should be more than 6 months; 7. Patients in the study must not be suitable for radical treatment, such as surgery, radical radiotherapy and chemotherapy; Gene test indicated that targeted therapy was not suitable for patients. 8. Biopsy tissue and blood samples can be provided for LRPPRC testing before and after treatment; 9. Life expectancy should be at least 3 months; 10. ECOG score: 0-2; 11. When the main organs are functioning normally, they meet the following criteria: (1) blood routine examination standards should be met (no blood transfusion and blood products within 14 days, no correction with g-csf and other hematopoietic stimulating factors) : A. HB 90 g/L or higher; B. the ANC acuity 1.5×10^9 / L; C. PLT acuity 80×10^9 / L; (2) biochemical examination shall meet the following standards: A.TBIL 45ml/min(Cockcroft-Gault) 12. Women of child-bearing age must have taken reliable contraceptive measures or have had a pregnancy test (serum or urine) within 7 days of enrollment, which was negative, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, consent is required to use appropriate methods of contraception or to have been surgically sterilized during the trial and 8 weeks after the last administration of the test drug; 13. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Allergy to gossypol acetate, docetaxel and platinum has been confirmed; 2. People with high blood pressure and antihypertensive drug treatment can not drop to normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with II magnitude coronary heart disease, arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and III - IV cardiac insufficiency; 3. Multiple factors affecting oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction); 4. Patients with a clear tendency of gastrointestinal bleeding include the following cases: patients with local active ulcer lesions and fecal occult blood (++) cannot be enrolled; History of black stool or hematemesis within 2 months; For patients with fecal occult blood (+) and unresected primary lesions of gastric tumors, gastroscopy is required, such as ulcerative gastric cancer, and major researchers believe that massive gastrointestinal bleeding may occur. 5. Abnormal coagulation function (INR>1.5, APTT> 1.5uln), with bleeding tendency; 6. Patients with central nervous system metastasis accompanied by symptoms; 7. Pregnant or lactating women or men with fertility requirements; 8. Have a history of psychotropic substance abuse and cannot quit or have a mental disorder; 9. Patients who have participated in clinical trials of other drugs within 4 weeks; 10. Clinical manifestations of brain metastasis; 11. Female or male patients with pregnancy requirements; 12. The inestigators considered the inclusion inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease control rate;SREs; | — |
Countries
China
Contacts
Public ContactSun Guogui, Fang Xiaohong
Second Department of Radiotherapy, Tangshan People's Hospital
Outcome results
None listed