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Intraperitoneal tumor vesicles wrapped methotrexate therapy safety and efficacy of openness malignant ascites, randomized controlled clinical study

Intraperitoneal tumor vesicles wrapped methotrexate therapy safety and efficacy of openness malignant ascites, randomized controlled clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16007842
Enrollment
Unknown
Registered
2016-01-27
Start date
2016-02-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Tumor

Interventions

Parallel control group:50ml normal saline cisplatin 60mg + dexamethasone 10 mg intraperitoneal treatment
Experimental group:tumor-derived cells vesicles wrap methotrexate intraperitoneal treatment

Sponsors

Tianjin Nankai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) by pathology or cytology diagnosed as malignant, abdominal B ultrasound or CT diagnosis ascites; (2) Smooth vital signs, KPS (Karnofsky) >=60 points; (3) Aged 18-70 years; (4) normal bone marrow function, no bleeding tendency (INR =90g/L, WBC> 4.0*10^9/L (NEU>=1.5*10^9/L), PLT>=100*10^9/L; (5) The liver function: total bilirubin =60mL/min; (7) with normal ECG, blood sugar levels were normal; (8) patients or their families agreed to participate in the study, and informed consent; (9) No other serious heart and lung diseases.

Exclusion criteria

Exclusion criteria: (1) breast-feeding, pregnant or are preparing to pregnant women; (2) allergies and multiple drug allergies; (3) has a serious heart, major organs lungs, liver and kidney dysfunction, such as decompensated heart, lung, kidney, liver dysfunction, failure or poor glycemic control who can not tolerate chemotherapy; (4) complicated by severe infection; (5) there is cognitive dysfunction, the researchers determined that patients undergoing chemotherapy or with poor compliance; (6) persons participating in other clinical trials within three months; (7) The researchers believe that those who are unsuitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
The Efficacy of Ascites;

Secondary

MeasureTime frame
vital signs;Quality of Life;Survival;Ascites routine;Ascites biochemical;Ascites tumor markers;Blood tumor markers;

Countries

China

Contacts

Public ContactHui Zhang
zhanghui740824@126.com+86 18522978701

Outcome results

None listed

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