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Perspective study for safty and efficacy of doxorubicin packaging microparticles in treatment of recurrent/refractory ovarian cancer ascites by peritoneal perfusion

Perspective study for safty and efficacy of doxorubicin packaging microparticles in treatment of recurrent/refractory ovarian cancer ascites by peritoneal perfusion

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033851
Enrollment
Unknown
Registered
2020-06-14
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent/refractory of ovarian cancer ascits

Interventions

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. In patients with ascites confirmed by B-ultrasound, the degree of ascites is 2 and 3; (EASL guideline and ICA consensus); 2. Patients diagnosed as ovarian cancer by pathology or clinical diagnosis, and patients with ascites exfoliative cytology found tumor cells; 3. Patients who have received at least one protocol standard anti-tumor treatment; 4. Patients who have not received local intraperitoneal administration in the past 4 weeks; 5. Patients with stable vital signs, Karnofsky = 70 and expected survival time greater than 3 months; 6. patients aged 18-75 years; 7. For patients with normal hematopoiesis, the blood routine test: Hgb >=90g/L, WBC >=2.5x10^9/L (neu >=1.5x10^9/L), PLT >=90x10^9/L; 8. The coagulation function was normal without bleeding tendency (INR =60ml / min; 11. The patient must obtain a written informed consent before giving any operation related to the clinical study, which shall be signed and dated by himself.

Exclusion criteria

Exclusion criteria: 1. Patients with non malignant ascites; 2. Patients with other serious cardiopulmonary diseases; 3. Patients with extensive abdominal adhesions; encapsulated peritoneal effusion; intestinal obstruction; history of intestinal perforation; patients with cachexia with terminal extensive metastasis; 4. Women who are breastfeeding, pregnant or preparing for pregnancy; 5. Patients with severe hypoproteinemia whose ALB is less than 30g / L; 6. Patients who are known to be allergic to test sample ingredients or their analogues; 7. Patients with other severe, acute or chronic diseases that may interfere with the interpretation of the results of the study, who are not suitable for the clinical trial according to the judgment of the investigator; 8. Patients with cognitive impairment or poor treatment compliance as determined by researchers; 9. Patients who participated in other clinical trials within 4 weeks; 10. patients who are not considered suitable for clinical trials by the researchers.

Design outcomes

Primary

MeasureTime frame
ORR of malignant ascites;

Secondary

MeasureTime frame
QOL;Tumor markers in ascites;

Countries

China

Contacts

Public ContactXingsheng Yang

Qilu Hospital of Shandong University

xingshengyang@sdu.edu.cn+86 18560081997

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026