An interventional study of Yishen Qutong Granules and Yishen Qutong Simulant Granules in SCLC, Extensive Stage, sponsored by LI FENG. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by LI FENG · Not applicable, Interventional, and Treatment
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%."
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.
This study's planned enrollment of 224 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →LI FENG is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Yishen Qutong Granules administered at 10g per dose, three times daily, in conjunction with immunotherapy plus etoposide and platinum-based first-line treatment.
Drug: Yishen Qutong Granules
In parallel with immunotherapy plus etoposide and platinum-based first-line treatment, administer a simulated formulation of Yishen Qutong Granules (1/10 Yishen Qutong Granules), 10g per dose, three times daily.
Drug: Yishen Qutong Simulant Granules
The patent prescription of Professor Feng Li, the head of the Department of Traditional Chinese Medicine at the Cancer Hospital of the Chinese Academy of Medical Sciences.
Yishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules.
Objective Response Rate, ORR
Objective response rate = (complete response + partial response) / total number of patients × 100%.
Time frame: The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.
Numerical Rating Scale
The NRS scoring method divides pain into 10 levels, using a scoring range of 0-10. Patients need to choose a level based on their own feelings to represent their pain intensity. The specific classifications are as follows: Grade 0: indicates no pain or no symptoms. Grades 1-3: indicate mild pain, usually not affecting sleep. Grades 4-6: indicate moderate pain, sleep may be affected. Grades 7-10: indicate severe pain, seriously affecting sleep and quality of life.
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
QLQ-C30 scale point
The EORTC QLQ-C30 is a 30-item questionnaire evaluating cancer patients' quality of life across multiple dimensions, including physical, emotional, cognitive, and social functioning, as well as symptom burden (e.g., fatigue, pain, nausea). Scores range from 0 to 100, with higher scores in functional scales and global health status indicating better quality of life, and higher scores in symptom scales indicating worse symptoms.
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Overall Survival, OS
The period from the commencement of treatment until the patient's death from any cause.
Time frame: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
Cancer-related fatigue state
Assessment was conducted using the BFI scale and the Fatigue-Related Quality of Life (FACIT-F scale).
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after.
Physical Condition Score
Karnofsky Performance Status、Eastern Cooperative Oncology Group Performance Status
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Emotional state
Anxiety levels will be assessed using the HADS-A scale, while depression levels will be evaluated using the HADS-D scale.
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
progression-free survival，PFS
Time from randomization to first radiographic tumor progression.
Time frame: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine
The effective rate of Traditional Chinese Medicine syndromes = (number of markedly effective cases + number of effective cases) / total number of cases in the group × 100%.
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Assess the impact of lung disease on patients
Lung Cancer Subscale (FACT-L) - Lung Cancer-Specific Items and St. George's Respiratory Questionnaire (SGRQ)
Time frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Tumor markers
Includes commonly used tumor markers for small cell lung cancer: progastrin-releasing peptide (ProGRP) and neuron-specific enolase (NSE), as well as carcinoembryonic antigen (CEA).
Time frame: Before treatment initiation, and on Days 43, 90, 133, 233, 365 , 450,and 540.
Plan to share: No — The project involves some patents that will not be disclosed at this time.
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 45 non-industry interventional studies with no phase under Small Cell Lung Carcinoma, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 73. This study's planned 11 months is below that.
Counting every sponsor, half of 47 studies reached it within 52 months; a quarter within 25 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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LI FENG