Therapy with FZQXF to prevent the relapse of postoperative patients with early lung adenocarcinoma patients: a randomized, double-blind, placebo-parallel controlled, multicenter clinical trial

Not Applicable

• Conditions: Stage IA-IB adenocarcinoma of the lung

• Registration Number: ITMCTR2000003600
• Lead Sponsor: Department of Oncology of Shanghai Traditional Chinese Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients conforming to lung adenocarcinoma, with stage Ia and Ib clinical stages and without adjuvant therapy after radical resection, within half a year after operation;
(2) Patients aged between 18 and 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 <90IU/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.

Exclusion Criteria

(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 dependents;
(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
recurrence rate;OS;PFS;

Secondary Outcome Measures

Name	Time	Method
K cells (CD3-CD56dimCD16+);NSE;MDSC(CD11b+ Gr-1+);SCC;Treg (CD4+CD25+Foxp3+);T cell subsets (CD3+CD4+CD8+);B cells (CD19+);CEA;CY-211;