Randomized Controlled Clinical Study to Evaluate the Efficacy and Safety of Integrated Traditional Chinese Medicine Treatment as Maintenance Therapy for Patients with Advanced Non-small-cell Lung Cancer

Clinical Study of Integrated Traditional Chinese Medicine Treatment as Maintenance Therapy for Patients with Advanced Non-small-cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10001017

Enrollment

Unknown

Registered

2010-09-05

Start date

2009-07-01

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

advanced non-small-cell lung cancer (stage IIIB/IV)

Interventions

Group A:Integrated TCM treatment regimen include herbal injection(cinobufacini injection or Yan-shu injection), herbal decoction(Ziyin Shengjing Jiedu Fang, Yiqi Jianpi Jiedu Fang, or Yiqi Yangyin Jie

Group B:Single-agent maintenance chemotherapy regimen: pemetrexed 500mg/m2 vein Infusion on day 1, docetaxel 75mg/m2 vein Infusion on day 1, or gemcitabine 1000mg/m2 vein Infusion on day 1and day 8 ev

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients had histologic or cytologic proof of NSCLC,including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma; 2. Patients were classified as stage IIIB or stage IV. All patients had evaluable lesions. Non-radical surgery or recurrences after surgery were eligible; 3. Aged 18 to 75 years old; 4. All patients belonged to the type of Deficiency of Yin, Deficiency of Qi, or Deficiency of both Qi and Yin by TCM Syndrome Differentiation; 5. After first-line treatment, patients with measurable disease were evaluated as complete response(CR) or partial response (PR) or disease stabilization(SD) which were defined by the Response Evaluation Criteria in Solid Tumors (RECIST); 6. Eastern Cooperative Oncology Group performance status (PS)of 0, 1, or 2; 7. Life expectancy of 6 months; 8. Adequate bone marrow reserve (absolute neutrophil count>=1.5*10^9/L, platelets>=80*10^9/L) and liver and renal function; 9. To be able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Radiation therapy or targeted therapy after first-line treatment; 2. Allergies to chemotherapy agents; 3. Patients who were participating in other drug trials; 4. Patients had other coexisting malignancies or serious complications or liver, kidney, heart dysfunction; 5. Patients who were pregnant or breast-feeding; 6. Patients had a history of mental illness which was difficult to control with.

Design outcomes

Primary

Measure	Time frame
1-year survival rate;overall survival;quality of life;time to progression;	—

Secondary

Measure	Time frame
TCM related symptoms;performance status;objective tumor respons;	—

Countries

China

Contacts

Public ContactLingshuang Liu

liulingshuang107@hotmail.com+86 13818510253

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026