Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer
SCLC, Extensive Stage
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 224 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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%."
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento triple
Treatment group(Yishen Qutong Granules)
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
Control group(Placebo)
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
Yishen Qutong Granules DRUG
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 DRUG
Yishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Objective Response Rate, ORR
Plazo: The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.
Objective response rate = (complete response + partial response) / total number of patients × 100%.
Medidas secundarias
Numerical Rating Scale
Plazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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.
QLQ-C30 scale point
Plazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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.
Overall Survival, OS
Plazo: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
The period from the commencement of treatment until the patient's death from any cause.
Cancer-related fatigue state
Plazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after.
Assessment was conducted using the BFI scale and the Fatigue-Related Quality of Life (FACIT-F scale).
Physical Condition Score
Plazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Karnofsky Performance Status、Eastern Cooperative Oncology Group Performance Status
Emotional state
Plazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Anxiety levels will be assessed using the HADS-A scale, while depression levels will be evaluated using the HADS-D scale.
progression-free survival，PFS
Plazo: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
Time from randomization to first radiographic tumor progression.
Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine
Plazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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%.
Assess the impact of lung disease on patients
Plazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Lung Cancer Subscale (FACT-L) - Lung Cancer-Specific Items and St. George's Respiratory Questionnaire (SGRQ)
Tumor markers
Plazo: Before treatment initiation, and on Days 43, 90, 133, 233, 365 , 450,and 540.
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).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (3)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
3 centros
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing, Beijing Municipality, ChinaEstado desconocido
Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical CollegeBeijing, Chaoyang, ChinaEstado desconocido
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing, ChinaEstado desconocido
Equipo y fechas
- Patrocinador principal
- LI FENG
- Inicio del estudio
- 1 ene 2027 Estimado
- Finalización primaria
- 31 dic 2027 Estimado
- Finalización del estudio
- 31 dic 2028 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026