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Multicenter randomized controlled trial for the efficacy of traditional Chinese medicine regimens on extensive-disease small-cell lung cancer (SCLC)

Multicenter randomized controlled trial for the efficacy of traditional Chinese medicine regimens on extensive-disease small-cell lung cancer (SCLC)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022991
Enrollment
Unknown
Registered
2019-05-06
Start date
2019-06-20
Completion date
Unknown
Last updated
2020-04-13

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

Conditions

Extensive-disease small-cell lung cancer

Interventions

The test group:Traditional Chinese medicine granules combined with chemotherapy
The control group:Placebo granules combined with chemotherapy

Sponsors

Beijing Hospital of TCM, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) patients diagnosed with small cell lung cancer by cytology or histology with distant organ metastasis and/or lymph node metastasis of the contralateral hilar lung in extensive-stage (via cranial MRI, chest CT, bone scan, abdominal CT or PET/CT); (2) did not receive radiotherapy, chemotherapy or surgical treatment, with evaluable lesions; (3) ECOG score 2, and the expected survival time is > for 3 months; (4) aged 18-75 years, with serious diseases of heart, brain, kidney, liver, blood and other systems; (5) agree to participate in this study and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) massive pleural or peritoneal effusion or pericardial effusion causes dyspnea; (2) symptomatic bone metastases requiring radiotherapy; (3) brain metastasis; (4) pregnant or lactating women, or serious diseases of heart, lung, liver, kidney, blood and other systems; (5) patients who are known to be allergic to the study drugs; (6) patients undergoing other drug trials.

Design outcomes

Primary

MeasureTime frame
OS;Safety index;

Secondary

MeasureTime frame
ORR;PFS;QOL;TCM syndromes related to lung cancer;tumor markers;

Countries

China

Contacts

Public ContactGuowang Yang

Beijing Hospital of TCM, Capital Medical University

guowangyang@sina.com+86 13701116943

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026