Lung AdenocarcinomaCJQD-CRFNCT07890051
Chaigui Jieyu Qufa Decoction for CRF in Driver Gene-negative Lung Adenocarcinoma Trial
A study testing Chai-Gui Jieyu Qufa Granules in people with Lung Adenocarcinoma and Cancer-related Fatigue, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this [clinical trial] is to [evaluate whether Chaiyu Jieyu Qufa Decoction can improve cancer-related fatigue and assess its safety] in [patients aged 18-80 years with untreated lung adenocarcinoma complicated with cancer-related fatigue of liver depression and spleen deficiency syndrome, who are scheduled… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Adenocarcinoma, Cancer-related Fatigue, Liver Depression and Spleen Deficiency Syndrome (Traditional Chinese Medicine)
- What is being tested?
- Chai-Gui Jieyu Qufa Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the western medicine diagnostic criteria for lung adenocarcinoma and cancer-related fatigue.
- Meet the traditional Chinese medicine diagnostic criteria for the syndrome of liver depression and spleen deficiency.
- Treatment-naive patients without prior anti-tumor therapy who are admitted to hospital for first-line treatment.
- Patients with lung adenocarcinoma planned to receive at least 2 cycles of platinum plus pemetrexed plus PD-1/PD-L1 inhibitor therapy.
- Hemoglobin concentration ≥90 g/L at enrollment.
- No concomitant or previous history of other primary malignant tumors.
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- Aged 18-80 years old, with expected survival > 3 months.
- Karnofsky Performance Status (KPS) score ≥60.
- Normal cognitive ability and capable of completing questionnaires.
- Voluntarily accept the study treatment regimen and sign the informed consent form.
Who cannot join
- Patients with severe cardiovascular and cerebrovascular diseases or severe hepatic and renal impairment.
- Patients receiving other treatments or medications that may affect cancer-related fatigue (CRF), such as acupuncture, ginseng, methylphenidate, modafinil, phenobarbital, phenytoin, primidone, phenylbutazone, monoamine oxidase inhibitors, benzodiazepines, clonidine and tricyclic antidepressants.
- History of psychiatric disorders including depression, obsessive-compulsive disorder or schizophrenia.
- Systemic steroid therapy within the past 6 months.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Trial of Chaigui Jieyu Qufa Decoction Versus Placebo in Cancer-related Fatigue of Driver Gene-negative Lung Adenocarcinoma
The goal of this [clinical trial] is to [evaluate whether Chaiyu Jieyu Qufa Decoction can improve cancer-related fatigue and assess its safety] in [patients aged 18-80 years with untreated lung adenocarcinoma complicated with cancer-related fatigue of liver depression and spleen deficiency syndrome, who are scheduled to receive first-line platinum plus pemetrexed combined with PD-1/PD-L1 therapy]. The main question[s] it aims to answer [is/are]:
[Does Chaiyu Jieyu Qufa Decoction reduce the severity of cancer-related fatigue measured by the Brief Fatigue Inventory (BFI) in patients with lung adenocarcinoma receiving platinum+pemetrexed+PD-1/PD-L1 treatment]? [Does Chaiyu Jieyu Qufa Decoction improve traditional Chinese medicine syndrome scores, fatigue-related quality of life, general quality of life, anxiety and depression status, tumour objective response rate and progression-free survival, without increasing safety risks]? If there is a comparison group: Researchers will compare [patients receiving Chaiyu Jieyu Qufa Decoction plus standard anti-tumour therapy] to [patients receiving placebo simulation agent plus the same standard anti-tumour therapy] to see if [the active herbal intervention achieves better relief of cancer-related fatigue and related secondary endpoints with acceptable safety].
Participants will Receive platinum plus pemetrexed combined with PD-1/PD-L1 immunotherapy as standard first-line anti-tumour treatment; Take either Chaiyu Jieyu Qufa Decoction or matching simulation agent orally, 200 mL twice daily for 21 days; Complete questionnaire assessments including BFI, FACIT-F, EORTC QLQ-C30 and HADS at scheduled time points; Undergo blood, urine and stool tests plus liver and kidney function tests for safety evaluation; Receive contrast-enhanced imaging examinations to evaluate tumour response at specified follow-up time points; Attend follow-up visits up to 333 days after study enrolment.
- Conditions
- Lung Adenocarcinoma, Cancer-related Fatigue, Liver Depression and Spleen Deficiency Syndrome (Traditional Chinese Medicine)
- Being tested
- Chai-Gui Jieyu Qufa Placebo Granules, Chai-Gui Jieyu Qufa Granules
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chai-Gui Jieyu Qufa Placebo GranulesOther
In the control group, on the basis of platinum plus pemetrexed plus PD-1/PD-L1 inhibitor therapy, participants receive Chai-Gui Jieyu Qufa placebo (1/10 strength of Chai-Gui Jieyu Qufa formula). The route of administration and treatment duration are identical to those in the experimental group.
Chai-Gui Jieyu Qufa GranulesDrug
Chai-Gui Jieyu Qufa Granules, a compound traditional Chinese herbal granule preparation. Oral administration, twice daily for 21days, combined with first-line platinum + pemetrexed + PD-1/PD-L1 inhibitor therapy for cancer-related fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Chai-Gui Jieyu Qufa Granules | Experimental | Traditional Chinese herbal granules. Participants take the granules orally for the treatment of cancer-related fatigue. Receives: Drug: Chai-Gui Jieyu Qufa Granules |
| Chai-Gui Jieyu Qufa Placebo Granules | Placebo comparator | Placebo granules, identical in appearance, smell and taste to the active herbal granules. Oral administration. Receives: Other: Chai-Gui Jieyu Qufa Placebo Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
BFI scale will be used to evaluate the severity of cancer-related fatigue in patients of the two groups.
Measured: 21days
Secondary outcomes (1)
Change in Traditional Chinese Medicine (TCM) syndrome score
The TCM syndrome score is used to assess the improvement of traditional Chinese medicine symptoms. The change from baseline in total TCM syndrome score will be compared between groups.
Measured: 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jan 2024
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890051
- Sponsor's protocol ID
- 2024-2-4028
- Acronym
- CJQD-CRF
- Status last verified
- Sep 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-controlled Clinical Trial of Chaigui Jieyu Qufa Decoction Versus Placebo in Cancer-related Fatigue of Driver Gene-negative Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07890051
- Acronym / sponsor ID
- CJQD-CRF / 2024-2-4028
- Conditions
- Lung Adenocarcinoma, Cancer-related Fatigue, Liver Depression and Spleen Deficiency Syndrome (Traditional Chinese Medicine)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this [clinical trial] is to [evaluate whether Chaiyu Jieyu Qufa Decoction can improve cancer-related fatigue and assess its safety] in [patients aged 18-80 years with untreated lung adenocarcinoma complicated with cancer-related fatigue of liver depression and spleen deficiency syndrome, who are scheduled to receive first-line platinum plus pemetrexed combined with PD-1/PD-L1 therapy]. The main question[s] it aims to answer [is/are]:
[Does Chaiyu Jieyu Qufa Decoction reduce the severity of cancer-related fatigue measured by the Brief Fatigue Inventory (BFI) in patients with lung adenocarcinoma receiving platinum+pemetrexed+PD-1/PD-L1 treatment]? [Does Chaiyu Jieyu Qufa Decoction improve traditional Chinese medicine syndrome scores, fatigue-related quality of life, general quality of life, anxiety and depression status, tumour objective response rate and progression-free survival, without increasing safety risks]? If there is a comparison group: Researchers will compare [patients receiving Chaiyu Jieyu Qufa Decoction plus standard anti-tumour therapy] to [patients receiving placebo simulation agent plus the same standard anti-tumour therapy] to see if [the active herbal intervention achieves better relief of cancer-related fatigue and related secondary endpoints with acceptable safety].
Participants will Receive platinum plus pemetrexed combined with PD-1/PD-L1 immunotherapy as standard first-line anti-tumour treatment; Take either Chaiyu Jieyu Qufa Decoction or matching simulation agent orally, 200 mL twice daily for 21 days; Complete questionnaire assessments including BFI, FACIT-F, EORTC QLQ-C30 and HADS at scheduled time points; Undergo blood, urine and stool tests plus liver and kidney function tests for safety evaluation; Receive contrast-enhanced imaging examinations to evaluate tumour response at specified follow-up time points; Attend follow-up visits up to 333 days after study enrolment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chai-Gui Jieyu Qufa Granules | Experimental | Drug: Chai-Gui Jieyu Qufa GranulesTraditional Chinese herbal granules. Participants take the granules orally for the treatment of cancer-related fatigue. |
| Chai-Gui Jieyu Qufa Placebo Granules | Placebo comparator | Other: Chai-Gui Jieyu Qufa Placebo GranulesPlacebo granules, identical in appearance, smell and taste to the active herbal granules. Oral administration. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meet the western medicine diagnostic criteria for lung adenocarcinoma and cancer-related fatigue.
- Meet the traditional Chinese medicine diagnostic criteria for the syndrome of liver depression and spleen deficiency.
- Treatment-naive patients without prior anti-tumor therapy who are admitted to hospital for first-line treatment.
- Patients with lung adenocarcinoma planned to receive at least 2 cycles of platinum plus pemetrexed plus PD-1/PD-L1 inhibitor therapy.
- Hemoglobin concentration ≥90 g/L at enrollment.
Key exclusion criteria (5 listed)
- Patients with severe cardiovascular and cerebrovascular diseases or severe hepatic and renal impairment.
- Patients receiving other treatments or medications that may affect cancer-related fatigue (CRF), such as acupuncture, ginseng, methylphenidate, modafinil, phenobarbital, phenytoin, primidone, phenylbutazone, monoamine oxidase inhibitors, benzodiazepines, clonidine and tricyclic antidepressants.
- History of psychiatric disorders including depression, obsessive-compulsive disorder or schizophrenia.
- Systemic steroid therapy within the past 6 months.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chai-Gui Jieyu Qufa Placebo GranulesIn the control group, on the basis of platinum plus pemetrexed plus PD-1/PD-L1 inhibitor therapy, participants receive Chai-Gui Jieyu Qufa placebo (1/10 strength of Chai-Gui Jieyu Qufa formula). The route of administration and treatment duration are identical to those in the experimental group. | Other | Chai-Gui Jieyu Qufa Placebo Granules |
| Chai-Gui Jieyu Qufa GranulesChai-Gui Jieyu Qufa Granules, a compound traditional Chinese herbal granule preparation. Oral administration, twice daily for 21days, combined with first-line platinum + pemetrexed + PD-1/PD-L1 inhibitor therapy for cancer-related fatigue. | Drug | Chai-Gui Jieyu Qufa Granules |
Primary outcome
BFI scale will be used to evaluate the severity of cancer-related fatigue in patients of the two groups.
Time frame: 21days
1 secondary outcome
Change in Traditional Chinese Medicine (TCM) syndrome score
Time frame: 21days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chai-Gui Jieyu Qufa Granules in people with Lung Adenocarcinoma and Cancer-related Fatigue, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BFI scale will be used to evaluate the severity of cancer-related fatigue in patients of the two groups. (time frame: 21days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.