Malignant Pleural EffusionPhase 3NCT04914598
A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions
A Phase 3 study testing ENDOSTAR，cisplatin in people with Malignant Pleural Effusion, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- ENDOSTAR，cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2021to Jun 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed cancer of any primary tumor type, Patients with Malignant Pleural Effusion or Ascites who remain poorly controlled after at least one systemic antitumor therapy and at least one local therapy (intracavitary administration of chemotherapeutic agents and/or biological response modulators, other than cisplatin.)
- At least a medium amount of malignant pleural effusion or ascites conformed by confirmed by B ultrasound, Clinical judgment requires local therapy.
- Karnofsky Performance Status ≥60
- Life expectancy of at least 3 months
- Adequate hematologic, cardiac, renal, and hepatic function
- The serum pregnancy test of female subjects of childbearing age during the screening period was negative; With a fertile female/male subjects must be willing to throughout the study period (i.e., for the first time since the drug delivery to the end of the study drug dosing after 90 days) to take reliable contraceptive methods, including but not limited to: abstinence, male partners have accepted vasectomy, female sterilization, intrauterine device effectively and effective birth control pills.
Who cannot join
- Participating in or receiving investigational treatment in another clinical trial within 4 weeks prior to first dosing, or participating in a device clinical trial within 4 weeks Evidence of bleeding diathesis, serious infection
- Received systemic antitumor therapy or intraperitoneal drug therapy within 14 days of the first intracavitary administration;
- Endostatin, bevacizumab, Ramucirumab, and other antiangiogenic agents or cisplatin were used for local therapy
- Has not recovered from any adverse event due to any intervention to ≤1 prior to initial administration (except for hair loss, hearing loss, and neurological or endocrine disorders of ≤2 requiring alternative treatment)
- Had undergone medium to major surgery other than diagnosis or biopsy within 28 days prior to first administration, or who were expected to undergo major surgery during the study period
- Bilateral pleural effusion or enveloped pleural effusion or ascite
Show all 11Show fewer
- With severe COPD or a history of intestinal adhesions
- uncontrolled primary brain tumor or central nerve metastatic tumor with significant intracranial hypertension or neuropsychiatric symptoms
- Active infections that require systemic treatment
- Pregnant or lactating women
- history of illness, treatment, or laboratory abnormality that may interfere with the outcome of the study and prevent subjects from participating fully in the study, or participation is not considered by the investigator to be in the subjects' best interest.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Double-blind, Multi-center Phase Ⅲ Registration Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions
Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites.
- Conditions
- Malignant Pleural Effusion
- Being tested
- ENDOSTAR，cisplatin, Placebo , cisplatin
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOSTAR，cisplatinDrug
After sufficient puncture and drainage or drainage, use Endo® (45mg/time in thoracic cavity, 60mg/time in abdominal cavity) + cisplatin (40mg/time) intracavitary injection, administration on 1, 4, and 7 days, 3 times as a course of treatment
Placebo , cisplatinDrug
Placebo , cisplatin
| Study group | Role | What they receive |
|---|---|---|
| ENDOSTAR combined with cisplatin | Active comparator | Not described Receives: Drug: ENDOSTAR，cisplatin |
| Placebo combined with cisplatin | Placebo comparator | Not described Receives: Drug: Placebo , cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puncture/drainage-Free Survival, PuFS
Compared with placebo combined with intracavitary cisplatin injection, use Puncture/drainage-Free Survival (Puncture/drainage-Free Survival, PuFS) as an indicator to evaluate Endo® combined with cisplatin intracavitary injection in the treatment of malignant pleural or ascites effusion Efficacy.
Measured: From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start28 Jul 2021
- Primary completion10 Feb 2025
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Jiangsu Simcere Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shukui Qin, Doctor, Study chair, Shanghai East Hospital of Tongji UniversityJin Li, Doctor, Study chair, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914598
- Sponsor's protocol ID
- SIM-372-ENDO-301
- Status last verified
- Dec 2025
- First submitted
- 27 May 2021
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind, Multi-center Phase Ⅲ Registration Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions
- ClinicalTrials.gov ID
- NCT04914598
- Acronym / sponsor ID
- SIM-372-ENDO-301
- Conditions
- Malignant Pleural Effusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Jun 2021 (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.
Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENDOSTAR combined with cisplatin | Active comparator | Drug: ENDOSTAR，cisplatin |
| Placebo combined with cisplatin | Placebo comparator | Drug: Placebo , cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed cancer of any primary tumor type, Patients with Malignant Pleural Effusion or Ascites who remain poorly controlled after at least one systemic antitumor therapy and at least one local therapy (intracavitary administration of chemotherapeutic agents and/or biological response modulators, other than cisplatin.)
- At least a medium amount of malignant pleural effusion or ascites conformed by confirmed by B ultrasound, Clinical judgment requires local therapy.
- Karnofsky Performance Status ≥60
- Life expectancy of at least 3 months
- Adequate hematologic, cardiac, renal, and hepatic function
Key exclusion criteria (11 listed)
- Participating in or receiving investigational treatment in another clinical trial within 4 weeks prior to first dosing, or participating in a device clinical trial within 4 weeks Evidence of bleeding diathesis, serious infection
- Received systemic antitumor therapy or intraperitoneal drug therapy within 14 days of the first intracavitary administration;
- Endostatin, bevacizumab, Ramucirumab, and other antiangiogenic agents or cisplatin were used for local therapy
- Has not recovered from any adverse event due to any intervention to ≤1 prior to initial administration (except for hair loss, hearing loss, and neurological or endocrine disorders of ≤2 requiring alternative treatment)
- Had undergone medium to major surgery other than diagnosis or biopsy within 28 days prior to first administration, or who were expected to undergo major surgery during the study period
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 |
|---|---|---|
| ENDOSTAR，cisplatinAfter sufficient puncture and drainage or drainage, use Endo® (45mg/time in thoracic cavity, 60mg/time in abdominal cavity) + cisplatin (40mg/time) intracavitary injection, administration on 1, 4, and 7 days, 3 times as a course of treatment | Drug | ENDOSTAR combined with cisplatin |
| Placebo , cisplatinPlacebo , cisplatin | Drug | Placebo combined with cisplatin |
Primary outcome
Puncture/drainage-Free Survival, PuFS
Time frame: From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months
Compared with placebo combined with intracavitary cisplatin injection, use Puncture/drainage-Free Survival (Puncture/drainage-Free Survival, PuFS) as an indicator to evaluate Endo® combined with cisplatin intracavitary injection in the treatment of malignant pleural or ascites effusion Efficacy.
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 2 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Shukui Qin, Doctor study chair
Shanghai East Hospital of Tongji University
Jin Li, Doctor study chair
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ENDOSTAR，cisplatin in people with Malignant Pleural Effusion, run by Jiangsu Simcere Pharmaceutical Co., Ltd. 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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Puncture/drainage-Free Survival, PuFS (time frame: From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months). 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 2 Jan 2026.