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Multi-center randomized controlled clinical trial of comprehensive treatment with Traditional Chinese Medicine and adjuvant chemotherapy on preventing the recurrence and metastasis of non-small cell lung cancer after radical operation

Multi-center randomized controlled clinical trial of comprehensive treatment with Traditional Chinese Medicine and adjuvant chemotherapy on preventing the recurrence and metastasis of non-small cell lung cancer after radical operation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009062
Enrollment
Unknown
Registered
2016-08-22
Start date
2016-10-01
Completion date
Unknown
Last updated
2017-04-18

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

experimental group:Comprehensive treatment (adjuvant chemotherapy and treatment of TCM )
control group:Adjuvant chemotherapy and placebo

Sponsors

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) patients with complete resection who are at TNM stage Ib-?a, postoperative pathology confirmed for non-small cell lung cancer; (2) patients who are within 6 weeks after complete resection have not been treated; (3) TCM syndrome differentiation is Qi deficiency syndrome, yin deficiency syndrome or Qi and Yin deficiency syndrome; (4) aged 18-75 years old (including 18, 75); (5) Eastern Cooperative OncologyGroup (ECOG) PS of two or less; (6) normal hematological function with total neutrophil count> 1.5 x 10^9/L, platelets count > 100 x 10^9/L , Lhemoglobin > 100 mg/dl and normal liver functionand kidney function; (7) patients compliance is good, and patients can understand the situation of this study and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) expected lifetime < 6 months; (2) there is no clear pathological diagnosis; (3) patients with intentional liver, kidney and hematopoietic diseases; (4) patients with pregnancy or lactation; (5) patients with hisory of serirous mental illness.

Design outcomes

Primary

MeasureTime frame
2-year disease-free survival rate;Disease-free survival, DFS;

Secondary

MeasureTime frame
Quality of life;ECOG Performance Status;symptoms lists questionnaire of traditional Chinese medicine;Overall survival;CEA(Carcino Embryonie Antigen);CA125 (Carbohydrate Antigen 125);CYFRA21-1(cytokeratin fragment antiogen 21-1);

Countries

China

Contacts

Public ContactLingshuang Liu

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

liuls107@163.com+86 13818510253

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 11, 2026