Herbal mix and cancer drug join forces to fight fluid in lungs
NCT ID NCT07670338
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests whether adding a Chinese herbal formula (Xuanyin Ning) to a standard cancer drug (bevacizumab) can better control malignant pleural effusion—fluid buildup in the chest caused by advanced lung cancer. About 308 participants will receive either the herbal formula or a placebo, along with bevacizumab injected into the chest after drainage. The goal is to see if the combination improves fluid control, breathing, and quality of life over 8 weeks of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Xuanyin Ning Formula (Chinese herbal granules) and bevacizumab (a cancer drug injected into the chest)
- What this could lead to
- If it works, this combination could offer a new way to better control fluid buildup in the chest, improving breathing and quality of life for people with advanced lung cancer.
- What could go wrong
- This is an early-stage trial with no phase listed, so results are uncertain. The herbal formula may not add benefit over standard care, and bevacizumab carries risks like bleeding or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 308 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with advanced non-squamous non-small cell lung cancer who have failed at least first-line systemic therapy; * Presence of unilateral pleural effusion confirmed as malignant by pathology or cytology, with at least moderate volume requiring drainage (moderate pleural effusion defined as: supine ultrasound examination showing pleural effusion ≥3 cm, or sitting ultrasound examination showing pleural effusion ≥4 cm,accompanied by clinical symptoms such as chest tightness and dyspnea); * Age 18-75 years; * ECOG performance status 0-2; * Traditional Chinese Medicine (TCM) syndrome differentiation classified as Xuanyin (suspension fluid) with fluid retention in the chest and hypochondrium; * Expected survival of at least 3 months; * Voluntarily signed informed consent before treatment; * No contraindications to chest tube placement for drainage; * Adequate major organ function, including: 1. Complete blood count: White blood cell count ≥ 4.0×10⁹/L Absolute neutrophil count ≥ 1.5×10⁹/L Platelet count ≥ 100×10⁹/L Hemoglobin ≥ 90 g/L 2. Blood biochemistry: Total bilirubin ≤ 1.5×ULN ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula) 3. Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN 4. Blood glucose: within normal range, or diabetic patients under treatment with stable blood glucose control; * Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug administration, and must use effective contraception (e.g., intrauterine device, contraceptive pills, or condoms) during the study period and for at least 3 months after the last dose. -Male subjects with a partner of childbearing potential must use effective contraception during the study period and for 3 months after the last dose; * Good subject compliance, able to follow up for efficacy and adverse events/reactions as required by the protocol. Exclusion Criteria: * The location of pleural effusion is unsuitable for drainage, or the patient would not benefit from intrapleural drug administration (e.g., severe loculation/septation); * Other contraindications to indwelling chest tube placement; * Pleural effusion with active infection; * Prior history of ipsilateral chest tube drainage and intrapleural anti-tumor drug therapy or pleurodesis; * Prior history of empyema or chylothorax; * Participation in another clinical trial within 4 weeks before signing informed consent; * Known allergy to any component of the study drugs; * Severe bleeding tendency or active bleeding; * Uncontrolled severe hypertension; * Recent (within 3 months) thromboembolic events, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, etc.; * Prior severe adverse reactions to intravenous bevacizumab, such as severe proteinuria, gastrointestinal perforation, hypertensive crisis, etc.; * Severe cardiac, hepatic, or renal insufficiency; * Pregnant or breastfeeding women; * Subjects with other active infectious diseases in the acute phase; * Any other factors that, in the investigator's judgment, may lead to premature termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, family or social factors that may affect the subject's safety or compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030, China
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Shanghai Tenth People's Hospital Chongming Branch
Shanghai, Shanghai Municipality, 202157, China
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The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
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Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital
Weifang, Shandong, 261041, China
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Wuhan First Hospital
Wuhan, Hebei, 430022, China
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Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a pill combo outperform standard therapy for a Hard-to-Treat lung cancer?
- Disposable scope takes on gold standard in pleural diagnosis
- New injection aims to ease breathing in cancer patients with Fluid-Filled lungs
- Lung cancer drug matching: lab test could personalize treatment
- Researchers test if electronic health records can mimic Gold-Standard cancer studies
- Experimental chest injection aims to stop cancer fluid buildup