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

November 4, 2026 updated by: 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%."

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 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 Comparator: 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 Simulant Granules is a preparation with one-tenth the dosage of Yishen Qutong Granules.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate, ORR
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LI FENG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University Cancer Hospital & Institute
Beijing Chest Hospital, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SF2026-1-4022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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