YSQTG Combined With Immuno-chemotherapy for Extensive-Stage Small Cell Lung Cancer

February 5, 2026 updated by: LI FENG

Yishen Qutong Granules Combined With Immunochemotherapy for Extensive-Stage Small Cell Lung Cancer: A Multicentre, Randomised, Triple-Blind, Placebo-Controlled Trial

Globally, lung cancer stands as the foremost cause of cancer-related mortality. Among its subtypes, small cell lung cancer (SCLC) represents an exceptionally aggressive malignancy, accounting for approximately 15-20% of all lung cancer cases. Over two-thirds of SCLC patients are diagnosed at an extensive stage, facing a median survival of only 7-12 months, a 2-year survival rate below 5%, and a dismal 5-year survival rate of 2%, underscoring its poor prognosis and high mortality. First-line treatment for extensive-stage SCLC typically involves comprehensive therapy centered on chemotherapy, often combined with immunotherapy. While this approach can achieve response rates of 50-70%, it is frequently accompanied by significant adverse effects, including bone marrow suppression and debilitating gastrointestinal reactions such as nausea, vomiting, and anorexia. The considerable toxicity associated with chemotherapy poses a major clinical challenge, limiting the potential for dose or duration escalation and hindering further efficacy gains. Therefore, developing strategies to mitigate toxicity while enhancing therapeutic efficacy remains an urgent clinical priority.

In the paradigm of Traditional Chinese Medicine (TCM), extensive-stage SCLC is categorized under syndromes such as "pulmonary accumulation," "cough," and "consumptive disease." Its fundamental pathogenesis is characterized by a deficiency of healthy qi (vital energy) alongside an excess of pathogenic factors, primarily "toxins," "stasis," and "phlegm." The core pathological mechanism involves the internal accumulation of toxins, disruption of the lung's dispersing and descending functions, disharmony of qi and blood, and consequent depletion of vital qi over time. Treatment strategies thus aim to resolve toxins, dispel stasis, and reinforce the body's vital qi. Preliminary clinical observations suggest that the TCM formula Yishen Qutong Granules, developed based on the theories of "reinforcing healthy qi to resolve toxins" and the "metal-water mutual generation" principle, can significantly alleviate symptoms in SCLC patients. Building on this foundation, the present study proposes to evaluate the integration of Yishen Qutong Granules with standard chemo-immunotherapy for extensive-stage SCLC, with the objectives of improving patients' quality of life and extending overall survival.

To this end, investigators will conduct a multicenter, randomized, triple-blind, placebo-controlled clinical trial. A total of 308 patients with extensive-stage SCLC, who are scheduled to undergo first-line immunotherapy combined with etoposide and platinum-based chemotherapy, will be enrolled from participating centers. Participants will be randomly allocated in a 1:1 ratio to either the treatment group or the control group (n=154 each). The treatment group will receive oral Yishen Qutong Granules (10g, three times daily) in addition to the standard chemo-immunotherapy regimen. The control group will receive an identical regimen of standard therapy along with a matched placebo granule. The intervention period for the herbal preparation/placebo is 90 days, and all patients will be followed for 18 months. The primary efficacy endpoint is the Disease Control Rate (DCR). Secondary endpoints include Overall Survival (OS), Progression-Free Survival (PFS), TCM syndrome score (assessed using a validated scale), St. George's Respiratory Questionnaire (SGRQ) score, EORTC QLQ-C30 quality of life score, cancer-related fatigue, and emotional status. Safety will be rigorously monitored through serial assessments of routine blood/urine/stool tests, hepatic and renal function panels, and electrocardiograms. This study aims to generate high-level evidence for the integrative TCM-Western medicine approach and elucidate the potential role of Yishen Qutong Granules in the comprehensive management of extensive-stage SCLC.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

308

Phase

  • 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 Locations

  • China
    • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meets Western medical diagnostic criteria for extensive-stage small cell lung cancer and Chinese medicine diagnostic criteria for kidney deficiency with qi deficiency and stagnation of blood stasis;
  • Newly diagnosed extensive-stage small cell lung cancer patients who have not previously received Western medical antineoplastic therapy, with evaluable lesions;
  • Intended to receive ≥2 cycles of first-line immunotherapy plus platinum-based chemotherapy plus etoposide;
  • No concurrent or prior history of other primary malignancies;
  • Aged ≥18 years with an estimated survival period of ≥3 months;
  • Karnofsky Performance Status (KPS) ≥60 points;
  • Normal cognitive function sufficient to complete questionnaires;
  • Voluntary acceptance of the study treatment regimen and signing of informed consent.

Exclusion Criteria:

  • Pregnant or breastfeeding women, or individuals with severe diseases affecting the cardiovascular, pulmonary, hepatic, renal, or haematological systems;
  • 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
Intervention / Treatment
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.
Experimental: 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

Outcome Measure
Measure Description
Time Frame
Disease Control Rate（DCR）
Time Frame: Follow-up visits were conducted at 43 days, 90 days, 133 days, 233 days, 365 days (12 months), 450 days (15 months), and 540 days (18 months) after commencement, totalling seven visits.
Disease Control Rate (DCR) = (Complete Response + Partial Response + Stable Disease) /Total Number of Patients × 100%
Follow-up visits were conducted at 43 days, 90 days, 133 days, 233 days, 365 days (12 months), 450 days (15 months), and 540 days (18 months) after commencement, totalling seven visits.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival（OS）
Time Frame: Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
The period from the commencement of treatment until the patient's death from any cause
Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
progression-free survival（PFS）
Time Frame: Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
Time from study entry to first radiographic evidence of tumour progression
Before treatment commencement; 21 days after commencement; 43 days after; 90 days after; 133 days after; 233 days after; 365 days after; 450 days after; 540 days after
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 TCM Syndrome Score evaluates the severity of symptoms related to nodule accumulation, localized pain, tongue appearance, lumbar debility, and fatigue. Each symptom is scored from 0 to 6, with higher scores indicating more severe symptoms. The total score is the sum of individual symptom scores, reflecting the overall severity of TCM syndromes.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Quality of Life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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
St George' s Respiratory Questionnaire (SGRQ)
Time Frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

The St George's Respiratory Questionnaire (SGRQ) is a standardised self-assessment tool used to evaluate the quality of life in patients with chronic respiratory diseases. By quantifying the impairment experienced by patients in terms of symptoms, functional capacity, and psychosocial adjustment, it comprehensively reflects the impact of the disease on patients' daily lives.

Scale Range and Interpretation Total score range: 0 to 100. Higher scores indicate greater impairment of health-related quality of life due to respiratory symptoms.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Fatigue-Related Quality of Life (FACIT-F scale)
Time Frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Cancer-related fatigue was assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale.

Scale Range and Interpretation Total score range: 0 to 52. Higher scores indicate better fatigue-related quality of life (i.e., less fatigue and its impact).
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Brief Fatigue Inventory scale (BFI scale)
Time Frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Fatigue severity was assessed using the Brief Fatigue Inventory (BFI) scale. Scale Range and Interpretation Total score range: 0 to 10. Higher scores indicate more severe fatigue.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)
Time Frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Anxiety was assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).

Scale Range and Interpretation Total score range: 0 to 21. Higher scores indicate more severe anxiety symptoms.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement
Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)
Time Frame: Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Depression was assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D).

Scale Range and Interpretation Total score range: 0 to 21. Higher scores indicate more severe depressive symptoms.
Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement

Collaborators and Investigators

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

Sponsor

LI FENG

Collaborators

Shanxi Province Cancer Hospital
Fudan University
Henan Cancer Hospital

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)

February 17, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025YFC3508301

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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