A Clinical Study on the Yiqi Jiedu Method for Preventing Recurrence and Metastasis After Radical Surgery in Patients With Limited-Stage Small Cell Lung Cancer

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025001279

Enrollment

Unknown

Registered

2025-06-26

Start date

2025-01-08

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Small Cell Lung Cancer

Interventions

Control Group:Postoperative adjuvant chemotherapy ± radiotherapy combined with placebo

Qizhen Capsule Group:Postoperative adjuvant chemotherapy ± radiotherapy combined with Qizhen Capsules

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Postoperative pathological diagnosis of small cell lung cancer (SCLC) VALG stage: limited stage TNM stage: T1-2N0M0 clinical stage: I-IIA and has undergone complete surgical resection; 2) Planned to receive adjuvant chemotherapy within 6 weeks after surgery; 3) Traditional Chinese Medicine (TCM) syndrome differentiation: Qi deficiency and toxin stagnation syndrome; 4) Age between 18 and 75 years (including 18 and 75); 5) Performance status score = 2; 6) Absolute neutrophil count > 1.5 × 10?/L platelet count > 100 × 10?/L hemoglobin > 100 mg/dl aspartate aminotransferase (AST) < 40 U/L alanine aminotransferase (ALT) < 50 U/L creatinine < 97 µmol/L urea < 8 mmol/L; 7) Good patient compliance able to understand the study content and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with extensive-stage; 2) Expected survival time less than 6 months; 3) Presence of other serious systemic diseases; 4) Pregnant or breastfeeding women; 5) Patients with other concurrent primary malignant tumors; 6) Patients with uncontrolled psychiatric disorders; 7) Patients known to be allergic to the study medications; 8) Patients currently participating in other drug trials; 9) Patients who have experienced recurrence or metastasis before the first adjuvant treatment

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival Rate;	—

Secondary

Measure	Time frame
Traditional Chinese Medicine clinical symptom score;Performance status score;Quality of life assessment: EORTC QLQ-C30 and QLQ-LC13 questionnaires;Median disease-free survival (DFS);	—

Countries

China

Contacts

Public ContactQilong Gao

Henan Cancer Hospital

zlyygaoqilong1662@zzu.edu.cn18810465536

Outcome results

None listed

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