Malignant Pleural Effusions (Mpe)XYN-Bev MPENCT07670338
Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion
A study testing Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage in people with Malignant Pleural Effusions (Mpe), run by Shanghai Chest Hospital at 7 sites in China.
Trial summary
The goal of this clinical trial is to determine whether the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage is effective in treating malignant pleural effusion. It will also evaluate the safety of this combination therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Pleural Effusions (Mpe)
- What is being tested?
- Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 7 sitesChina
- Study dates
- 1 Jun 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Voluntarily signed informed consent before treatment;
- No contraindications to chest tube placement for drainage;
- Adequate major organ function, including:
- 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
- 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)
- Coagulation function:
- International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Ming Zhang, 18017320233, gason2000@126.com
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Zhongqi Wang, 18917763093, aledx@sina.com
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Yabin Gong, 18918923873, gongyabin@hotmail.com
Shanghai Tenth People's Hospital Chongming Branch
Shanghai, Shanghai Municipality, 202157
Yeyun Lu, 18916582319, 307997868@qq.com
Weifang Traditional Chinese Medicine Hospital 或 Weifang Traditional Chinese Hospital
Weifang, Shandong, 261041
Chaoguang Yan, 19953614610, 19953614610@126.com
Wuhan First Hospital
Wuhan, Hebei, 430022
Zuowei Hu, 13871029959, 827823053@qq.com
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
Xiaohong Kang, 19838276658, 394161891@qq.com
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of Xuan Yin Ning Formula Combined With Intrapleural Injection of Bevacizumab for the Treatment of Malignant Pleural Effusion.
The goal of this clinical trial is to determine whether the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage is effective in treating malignant pleural effusion. It will also evaluate the safety of this combination therapy. The main questions it aims to answer include:
Does the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage improve the objective response rate (ORR) of pleural effusion in patients with malignant pleural effusion? Does this combination therapy affect the duration of response (DoR), progression-free survival (PFS), overall survival (OS), degree of dyspnea, quality of life, and Traditional Chinese Medicine (TCM) pattern/syndrome evaluation in patients with malignant pleural effusion?
Read more
Participants will:
Receive intrapleural injection of bevacizumab via chest tube drainage, and take either Xuanyin Ning Formula or placebo granules daily for 8 weeks.
Undergo ultrasound assessment of pleural effusion at 2, 4, 8, and 12 weeks after the first intrapleural injection during closed chest drainage, followed by ultrasound assessments every 3 months (±7 days) until pleural effusion progression.
- Conditions
- Malignant Pleural Effusions (Mpe)
- Being tested
- Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage, Placebo granules plus chest tube drainage and intrapleural bevacizumab injection
- Medical subject headings
- Pleural Effusion, Malignant, Myeloproliferative Disorder, Chronic, with Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainageOther
After chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Xuanyin Ning is taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required.
Placebo granules plus chest tube drainage and intrapleural bevacizumab injectionDrug
After chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Placebo granules are taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Other: Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage |
| control group | Placebo comparator | Not described Receives: Drug: Placebo granules plus chest tube drainage and intrapleural bevacizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate of pleural effusion (ORR)
Measured: Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment
Secondary outcomes (6)
Duration of Response (DoR)
Measured: At 2, 4, 8, and 12 weeks after treatment
Progression-Free Survival (PFS)
Measured: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS)
Measured: From date of treatment until the date of death from any cause, assessed up to 100 months
Degree of dyspnea
Measured: At 2, 4, 8, and 12 weeks after treatment
ECOG score
The ECOG score is a widely used clinical tool for quantifying a cancer patient's general well-being and functional capacity in daily life. It is primarily employed in oncology trials, treatment planning, and prognosis assessment. The scale ranges from 0 to 5, with higher numbers indicating greater disability
Measured: At 2, 4, 8, and 12 weeks after treatment
Traditional Chinese Medicine (TCM) syndrome evaluation
Quantification: The scale standardizes the evaluation of clinical symptoms, signs, and tongue/pulse findings, which are traditionally assessed through the four examinations (inspection, hearing/smelling, inquiry, and palpation).
Objectivity: It aims to improve the objectivity and standardization of TCM diagnosis and treatment evaluation.
Efficacy Evaluation: It is frequently used to calculate a "total effective rate" based on the reduction in syndrome scores after treatment.
Scoring: Symptoms are typically graded on a scale (e.g., 0 for normal, 2 for mild, 4 for moderate, 6 for severe), and the total score reflects the overall severity of the syndrome
Measured: At 2, 4, 8, and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural Effusions (Mpe)Studies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ming, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670338
- Sponsor's protocol ID
- ZDYN-2024-A-147
- Acronym
- XYN-Bev MPE
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of Xuan Yin Ning Formula Combined With Intrapleural Injection of Bevacizumab for the Treatment of Malignant Pleural Effusion.
- ClinicalTrials.gov ID
- NCT07670338
- Acronym / sponsor ID
- XYN-Bev MPE / ZDYN-2024-A-147
- Conditions
- Malignant Pleural Effusions (Mpe)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 26 Jun 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 determine whether the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage is effective in treating malignant pleural effusion. It will also evaluate the safety of this combination therapy. The main questions it aims to answer include:
Does the Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage improve the objective response rate (ORR) of pleural effusion in patients with malignant pleural effusion? Does this combination therapy affect the duration of response (DoR), progression-free survival (PFS), overall survival (OS), degree of dyspnea, quality of life, and Traditional Chinese Medicine (TCM) pattern/syndrome evaluation in patients with malignant pleural effusion?
Participants will:
Receive intrapleural injection of bevacizumab via chest tube drainage, and take either Xuanyin Ning Formula or placebo granules daily for 8 weeks.
Undergo ultrasound assessment of pleural effusion at 2, 4, 8, and 12 weeks after the first intrapleural injection during closed chest drainage, followed by ultrasound assessments every 3 months (±7 days) until pleural effusion progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage |
| control group | Placebo comparator | Drug: Placebo granules plus chest tube drainage and intrapleural bevacizumab injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
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 |
|---|---|---|
| Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainageAfter chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Xuanyin Ning is taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required. | Other | experimental group |
| Placebo granules plus chest tube drainage and intrapleural bevacizumab injectionAfter chest tube drainage, bevacizumab 300 mg per dose, dissolved in 50 ml of normal saline, is injected intrapleurally. The injection may be repeated after 2 weeks depending on the control of pleural effusion. Placebo granules are taken as 2 sachets per day, one sachet dissolved in water and taken orally in the morning and one in the evening. Each treatment cycle is 4 weeks, and at least 2 cycles are required. | Drug | control group |
Primary outcome
Objective Response Rate of pleural effusion (ORR)
Time frame: Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment
6 secondary outcomes
Duration of Response (DoR)
Time frame: At 2, 4, 8, and 12 weeks after treatment
Progression-Free Survival (PFS)
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS)
Time frame: From date of treatment until the date of death from any cause, assessed up to 100 months
Degree of dyspnea
Time frame: At 2, 4, 8, and 12 weeks after treatment
ECOG score
Time frame: At 2, 4, 8, and 12 weeks after treatment
Traditional Chinese Medicine (TCM) syndrome evaluation
Time frame: At 2, 4, 8, and 12 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage in people with Malignant Pleural Effusions (Mpe), run by Shanghai Chest Hospital at 7 sites 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 18 inclusion and 15 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhang (18017320233, gason2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate of pleural effusion (ORR) (time frame: Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment). 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 1 Jul 2026.