A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions

NCT04914598 | Active Not Recruiting Phase 3

• 1 other identifier: SIM-372-ENDO-301
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• 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.

  From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months

Study Arms (2)

ENDOSTAR combined with cisplatin

ACTIVE COMPARATOR

Drug: ENDOSTAR，cisplatin

Placebo combined with cisplatin

PLACEBO COMPARATOR

Drug: Placebo , cisplatin

Interventions

ENDOSTAR，cisplatin DRUG

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

ENDOSTAR combined with cisplatin

Placebo , cisplatin DRUG

Placebo , cisplatin

Placebo combined with cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Yan Xie

Nanjing, China

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Shukui Qin, Doctor

  Shanghai East Hospital of Tongji University

  STUDY CHAIR

• Jin Li, Doctor

  Shanghai East Hospital of Tongji University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 4, 2021
• Study Start: July 28, 2021
• Primary Completion: February 10, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)