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Xuan Yin Ning Plus Bevacizumab for Malignant Pleural Effusion

ConditionMalignant Pleural Effusions (Mpe)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chest Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment with Xuanyin Ning Formula combined with intrapleural injection of bevacizumab via chest tube drainage

    Other intervention

    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 injection

    Drug

    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.

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate of pleural effusion (ORR)

Time frame
Before treatment and at 4 weeks, 8 weeks, and 12 weeks after treatment

Secondary outcomes

1

Duration of Response (DoR)

Time frame
At 2, 4, 8, and 12 weeks after treatment
2

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
3

Overall Survival (OS)

Time frame
From date of treatment until the date of death from any cause, assessed up to 100 months
4

Degree of dyspnea

Time frame
At 2, 4, 8, and 12 weeks after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: