Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer
NCT07928882, Not applicable, Not yet recruiting, LI FENG
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinical Study on Fuzheng Jiedu Huayu Therapy in Combination With Chemotherapy and Immunotherapy for Improving Survival Rates in Extensive-Stage Small Cell Lung Cancer | ClinicalTrials.gov |
| NCT number | NCT07928882 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 224 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | LI FENG | ClinicalTrials.gov |
| Conditions | SCLC, Extensive Stage | ClinicalTrials.gov |
| Interventions | Yishen Qutong Granules, Yishen Qutong Simulant Granules | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective Response Rate, ORR | 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%. | ClinicalTrials.gov |
| Secondary | Numerical Rating Scale | 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. | ClinicalTrials.gov |
| Secondary | QLQ-C30 scale point | 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. | ClinicalTrials.gov |
| Secondary | Overall Survival, OS | 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. | ClinicalTrials.gov |
| Secondary | Cancer-related fatigue state | 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). | ClinicalTrials.gov |
| Secondary | Physical Condition Score | Before treatment commencement, and at 21 days, 43 days, and 90 days after commencement | Karnofsky Performance Status、Eastern Cooperative Oncology Group Performance Status | ClinicalTrials.gov |
| Secondary | Emotional state | 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. | ClinicalTrials.gov |
| Secondary | progression-free survival，PFS | On days 43, 90, 133, 233, 365, 450 and 540 following the commencement of treatment. | Time from randomization to first radiographic tumor progression. | ClinicalTrials.gov |
| Secondary | Evaluation of Syndrome and Symptom Points of Traditional Chinese Medicine | 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%. | ClinicalTrials.gov |
| Secondary | Assess the impact of lung disease on patients | 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) | ClinicalTrials.gov |
| Secondary | Tumor markers | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 8
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)