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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003600
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Stage IA-IB adenocarcinoma of the lung

Interventions

Sponsors

Department of Oncology of Shanghai Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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 (hemobilirubin3.5x10^9/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

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.

Design outcomes

Primary

MeasureTime frame
recurrence rate;OS;PFS;

Secondary

MeasureTime frame
NK 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;

Countries

China

Contacts

Public ContactLi Yan

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chin

18916767226@163.com+86 18916767226

Outcome results

None listed

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