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Study on the Formula for Supporting the Normal Qi Extinguishing Wind Resolving Phlegm and Detoxifying to Reduce the Recurrence and Metastasis Rate of Limited-Stage Small Cell Lung Cancer

Study on the Formula for Supporting the Normal Qi Extinguishing Wind Resolving Phlegm and Detoxifying to Reduce the Recurrence and Metastasis Rate of Limited-Stage Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000698
Enrollment
Unknown
Registered
2024-11-12
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-09

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

experimental group:Fuzheng Xifeng Huatan Jiedu formula

Sponsors

China Academy of Traditional Chinese Medicine Guanganmen Hospital: China Academy of Chinese Medical Sciences Guang'anmen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 18~75 years old 2.Having a confirmed pathological diagnosis of small cell lung cancer (SCLC) and a tumor staging of limited-stage small cell lung cancer (LS-SCLC) according to the NCCN guidelines 3.Within one month after the completion of the first-line standard treatment (chemotherapy combined with concurrent chemoradiotherapy (CCRT)) 4.Performance status with an ECOG score of 0-2 5.Voluntarily participate in this study and sign the informed consent form 6.Agree to provide tissue blocks/slices for research use

Exclusion criteria

Exclusion criteria: 1.Having severe diseases of the heart liver kidneys or hematopoietic system 2.Patients known to be allergic to the study medication 3.Children pregnant women patients with psychiatric disorders and those with other malignant tumors 4.Patients currently participating in other drug trials 5.Patients who have previously received or are currently receiving any anti-tumor immunotherapy for SCLC 6.Patients who have used traditional Chinese medicine preparations (including Chinese herbal decoctions granules injections and patent Chinese medicines) within one month prior to enrollment

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival;recurrence and metastasis rate;

Secondary

MeasureTime frame
exosome detection;oral microbiota;CTC;symptoms in Traditional Chinese Medicine;liver function (ALT\AST);kidney function (Cr\BUN\eGFR);Proteomics;quality of life;Whole Exome Sequencing;anxious-depressive condition;Metabolomics;gut microbiota;physical status;complete blood count (HGB\RBC\WBC\NEUT%\LYMPH%\PLT);Overall Survival;Peripheral blood mononuclear cell;RNAseq;

Countries

China

Contacts

Public ContactGuo Qiujun

China Academy of Traditional Chinese Medicine Guanganmen Hospital: China Academy of Chinese Medical Sciences Guang'anmen Hospital

drguoqiujun@126.com15810857295

Outcome results

None listed

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