Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer
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%."
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Shengjuan Hu, M.D.
- Número de telefone: +86 18810165527
- E-mail: hsj18810165527@163.com
Locais de estudo
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Beijing, China, 100700
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100021
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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Chaoyang
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Beijing, Chaoyang, China, 100021
- Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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.
- No prior Western medical anti-tumor therapy, with evaluable lesions;
- Planned to receive at least 2 cycles of immunotherapy + platinum + etoposide regimen.
- Age 18 years or older, with an expected survival of ≥3 months;
- No history of other prior primary malignancies or malignancy merging.
- Karnofsky performance status score ≥ 60;
- Normal cognitive function and able to cooperate in completing the questionnaire;
- Voluntarily accept the treatment regimen of this study and sign the informed consent form.
Exclusion Criteria:
- Pregnant or lactating women, or patients with severe diseases of the heart, lung, liver, kidney, blood, or other systems;
- Participants in other clinical trials.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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. |
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. |
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Comparador de Placebo: 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. |
Yishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Objective Response Rate, ORR
Prazo: The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.
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Objective response rate = (complete response + partial response) / total number of patients × 100%. |
The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Numerical Rating Scale
Prazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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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. |
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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QLQ-C30 scale point
Prazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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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. |
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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Overall Survival, OS
Prazo: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
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The period from the commencement of treatment until the patient's death from any cause. |
On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
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Cancer-related fatigue state
Prazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after.
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Assessment was conducted using the BFI scale and the Fatigue-Related Quality of Life (FACIT-F scale). |
Before treatment commencement, and at 21 days, 43 days, and 90 days after.
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Physical Condition Score
Prazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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Karnofsky Performance Status、Eastern Cooperative Oncology Group Performance Status |
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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Emotional state
Prazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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Anxiety levels will be assessed using the HADS-A scale, while depression levels will be evaluated using the HADS-D scale. |
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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progression-free survival，PFS
Prazo: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
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Time from randomization to first radiographic tumor progression. |
On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
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Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine
Prazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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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%. |
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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Assess the impact of lung disease on patients
Prazo: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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Lung Cancer Subscale (FACT-L) - Lung Cancer-Specific Items and St. George's Respiratory Questionnaire (SGRQ) |
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
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Tumor markers
Prazo: Before treatment initiation, and on Days 43, 90, 133, 233, 365 , 450,and 540.
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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). |
Before treatment initiation, and on Days 43, 90, 133, 233, 365 , 450,and 540.
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Zugazagoitia J, Paz-Ares L. Extensive-Stage Small-Cell Lung Cancer: First-Line and Second-Line Treatment Options. J Clin Oncol. 2022 Feb 20;40(6):671-680. doi: 10.1200/JCO.21.01881. Epub 2022 Jan 5.
- Xie M, Vuko M, Rodriguez-Canales J, Zimmermann J, Schick M, O'Brien C, Paz-Ares L, Goldman JW, Garassino MC, Gay CM, Heymach JV, Jiang H, Barrett JC, Stewart RA, Lai Z, Byers LA, Rudin CM, Shrestha Y. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study. Mol Cancer. 2024 May 30;23(1):115. doi: 10.1186/s12943-024-02014-x.
- Kim SY, Park HS, Chiang AC. Small Cell Lung Cancer: A Review. JAMA. 2025 Jun 3;333(21):1906-1917. doi: 10.1001/jama.2025.0560.
- Tomic K, Vranic S. Small cell lung cancer (SCLC): At the door of targeted therapies. Biomol Biomed. 2025 Aug 29;26(1):1-4. doi: 10.17305/bb.2025.13195.
- Zhu L, Qin J. Predictive biomarkers for immunotherapy response in extensive-stage SCLC. J Cancer Res Clin Oncol. 2024 Jan 20;150(1):22. doi: 10.1007/s00432-023-05544-x.
- Chen Y, Li H, Fan Y. Shaping the tumor immune microenvironment of SCLC: Mechanisms, and opportunities for immunotherapy. Cancer Treat Rev. 2023 Nov;120:102606. doi: 10.1016/j.ctrv.2023.102606. Epub 2023 Aug 7.
- Shields MD, Chiang AC, Byers LA. Top advances of the year: Small cell lung cancer. Cancer. 2025 Mar 15;131(6):e35770. doi: 10.1002/cncr.35770.
- Qin K, Gay CM, Byers LA, Zhang J. The current and emerging immunotherapy paradigm in small-cell lung cancer. Nat Cancer. 2025 Jun;6(6):954-966. doi: 10.1038/s43018-025-00992-5. Epub 2025 Jun 5.
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- SF2026-1-4022
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The project involves some patents that will not be disclosed at this time.
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