Evidence based medicine study on prevention of postoperative recurrence and metastasis of non-small cell lung cancer with traditional Chinese Medicine

Clinical study on prevention and treatment of postoperative recurrence and metastasis of lung cancer with traditional Chinese medicine based on Registration Platform

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2022000017

Enrollment

Unknown

Registered

2022-06-19

Start date

2023-07-01

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

Non small cell lung cancer

Interventions

Control group:placebo

Treatment group:Xihuang Jiedu Capsule

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? Postoperative patients with stage ii-iiia NSCLC diagnosed by pathology or cytology; ? Patients without tumor after adjuvant therapy were enrolled within 1 month after adjuvant therapy; ? The adjuvant chemotherapy regimen is the cycle of scheme 4 specified in NCCN guidelines ? Age 18-75 years old; ? Ecog0-1 for physical condition score; ? Estimated survival period = 6 months; ? The subjects had no dysfunction of major organs, normal blood routine, liver, kidney and heart functions, liver function: blood bilirubin = 2.0uln, blood alanine aminotransferase and glutamic oxaloacetic aminotransferase = 5uln; Renal function: serum creatinine = 2.0uln, blood urea nitrogen = 2.0uln; Bone marrow reserve: WBC = 3.0 × 109/l, absolute value of neutrophils (ANC) = 1.5 × 109/l, PLT = 80 × 109/l, hemoglobin (Hgb) = 80g/l.

Exclusion criteria

Exclusion criteria: ? Preoperative neoadjuvant chemotherapy; ? Adenocarcinoma ex19del/l858r (+) patients ? In other clinical trials; ? Have a birth plan within one year and have been pregnant or breast-feeding patients; ? Those who cannot cooperate with the follow-up and are allergic to the study drug; ? Using immunotherapy or targeted therapy ? Any situation that may prevent the subjects from completing the follow-up process, including but not limited to severe and uncontrollable organic diseases or infections, unstable angina pectoris, congestive heart failure, etc; Severe liver and kidney dysfunction (serum creatinine = 1.5 times ULN; ALT or AST = 5 times ULN; bilirubin = 1.5 times ULN); Patients with nervous, mental disease or mental disorder accompanied by symptoms and difficult to control; The patients with central nervous metastasis whose condition is not controlled and who have obvious cranial hypertension or neuropsychiatric symptoms;

Design outcomes

Primary

Measure	Time frame
DFS;	—

Secondary

Measure	Time frame
TCM symptoms;Quality of Life;2-year DFS rate;Immune and inflammatory related indexes;1-year DFS rate;overall survival(OS);	—

Countries

China

Contacts

Public ContactWei Hou

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

houwei1964@163.com13701361625

Outcome results

None listed

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