Therapy with FZQXF to prevent the relapse of postoperative patients with stage IB-IIB lung adenocarcinoma after surgery and adjuvant chemotherapy:a prospective, cohort, two-center clinical study
- Conditions
- Stage IB-IIB lung adenocarcinoma
- Registration Number
- ITMCTR2000003597
- Lead Sponsor
- Department of Oncology of Shanghai Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients conforming to lung adenocarcinoma, whose clinical stage was stage IB-IIB radical surgery and completed postoperative adjuvant therapy, and patients within 3 months after adjuvant chemotherapy;
(2) Patients aged 18 to 80 years;
(3) Blood routine and biochemical indexes are basically normal, and there is no serious virus or bacterial infection;Patients without organ failure or severe heart disease (hemobilirubin <68 umol/L, aspartic acid aminotransferase <90 IU/L, creatinine <350 umol/L, white blood cell count >3.5x10^9/L and lower than 12x10^9/L, platelet count>80x10^9/L, hematocrit >0.20);
(4) No other serious complications;
(5) I agree to participate in the study and sign the informed consent with good compliance.
(6) Non-pregnant or lactating patients;
(7) No allergic reaction to the compatible ingredients in the prescription.
(1) Patients with cancer recurrence or metastasis;
(2) Patients receiving other drug intervention treatment (including other traditional Chinese medicine decoction pieces, chemotherapy, targeted drugs);
(3) Having a mental illness; Lack of autonomous behavior ability;
(4) Women who are pregnant or preparing for pregnancy or breastfeeding;
(5) Patients with heart, lung, brain, liver, kidney, hematopoietic system and other serious diseases or mental diseases;
(6) Allergic constitution or known allergy to the composition of this drug;
(7) Patients who are participating in other clinical trials or who have participated in other clinical trials within 3 months;
(8) Alcoholics and/or psychoactive substances, substance abusers and dependants;
(9) According to the judgment of the researchers, there are other lesions or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, which may easily lead to loss of follow-up.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS;OS;recurrence rate;
- Secondary Outcome Measures
Name Time Method MDSC(CD11b+ Gr-1+);NSE;B cells (CD19+);T cell subsets (CD3+CD4+CD8+);SCC;Treg (CD4+CD25+Foxp3+);NK cells (CD3-CD56dimCD16+);CEA;CY-211;