Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

4. november 2026 oppdatert av: LI FENG

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%."

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

224

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
      • Beijing, Kina, 100700
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100021
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Chaoyang
      • Beijing, Chaoyang, Kina, 100021
        • Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Yishen Qutong 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.
Placebo komparator: 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.
Legemiddel: Yishen Qutong Simulant Granules

Yishen Qutong Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate, ORR
Tidsramme: 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%.
The patient underwent a chest CT scan every two treatment cycles to evaluate antitumor efficacy.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numerical Rating Scale
Tidsramme: 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.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
QLQ-C30 scale point
Tidsramme: 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.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Overall Survival, OS
Tidsramme: 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.
On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.
Cancer-related fatigue state
Tidsramme: 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).
Before treatment commencement, and at 21 days, 43 days, and 90 days after.
Physical Condition Score
Tidsramme: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Karnofsky Performance Status、Eastern Cooperative Oncology Group Performance Status
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Emotional state
Tidsramme: 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.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
progression-free survival，PFS
Tidsramme: On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment.

Time from randomization to first radiographic tumor progression.
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
Tidsramme: 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%.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Assess the impact of lung disease on patients
Tidsramme: 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)
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Tumor markers
Tidsramme: 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).
Before treatment initiation, and on Days 43, 90, 133, 233, 365 , 450,and 540.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

LI FENG

Samarbeidspartnere

Peking University Cancer Hospital & Institute
Beijing Chest Hospital, Capital Medical University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

4. november 2026

Først innsendt som oppfylte QC-kriteriene

4. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SF2026-1-4022

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The project involves some patents that will not be disclosed at this time.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere