Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

224 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Small cell lung cancer (SCLC) is a highly aggressive neuroendocrine malignancy. Approximately 70% of patients are diagnosed with extensive-stage disease, and only a subset of patients benefit from immunotherapy. Under the leadership of Academician Sun Yan, the principal investigator, our research group previously relied on the Big Data Platform of the National Cancer Center and undertook major projects including those from the National Administration of Traditional Chinese Medicine, the Beijing Administration of Traditional Chinese Medicine for collaborative of major and difficult diseases with integrated traditional Chinese and Western medicine, as well as the National Key R\&D Program. A randomized controlled trial (RCT) of 600 cases demonstrated that the traditional Chinese medicine "Fuzheng Jiedu Huayu" (strengthening vital energy, detoxifying, and resolving stasis) combined with chemotherapy and immunotherapy synergistically improved progression-free survival and disease control rate in patients with extensive-stage SCLC. Building on this foundation, the current project will enroll 224 patients with extensive-stage SCLC (1:1 ratio). On the basis of first-line treatment with immunotherapy plus platinum-based agents and etoposide, patients will be administered either "Fuzheng Jiedu Huayu" traditional Chinese medicine or a placebo. The study will employ objective response rate, progression-free survival, and overall survival as outcome measures, conducting a multicenter, large-sample RCT. Additionally, a multimodal database of no less than 1000 cases will be established, striving to obtain an IND approval, thereby contributing to the realization of the goal set forth in the "Healthy China 2030" Planning Outline: "By 2030, increase the overall 5-year cancer survival rate by 15%."

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Meets the diagnostic criteria for ES-SCLC by pathology and imaging, as well as the diagnostic criteria of Traditional Chinese Medicine for Kidney Deficiency and Vital Essence Depletion with Stasis-Toxin Stagnation.
2. No prior Western medical anti-tumor therapy, with evaluable lesions;
3. Planned to receive at least 2 cycles of immunotherapy + platinum + etoposide regimen.
4. Age 18 years or older, with an expected survival of ≥3 months;
5. No history of other prior primary malignancies or malignancy merging.
6. Karnofsky performance status score ≥ 60;
7. Normal cognitive function and able to cooperate in completing the questionnaire;
8. Voluntarily accept the treatment regimen of this study and sign the informed consent form.

Exclusion Criteria:

1. Pregnant or lactating women, or patients with severe diseases of the heart, lung, liver, kidney, blood, or other systems;
2. Participants in other clinical trials.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Triple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (3)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

3 locations

Study team and timeline

Lead sponsor

LI FENG

Study start

Jan 1, 2027 Estimated

Primary completion

Dec 31, 2027 Estimated

Study completion

Dec 31, 2028 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts