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Multicenter randomized controlled trial for microsphere-loaded embolization chemotherapy for the treatment of advanced esophageal cancer with stenosis

Multicenter randomized controlled trial for drug-loaded microspheres in the clinical application of advanced esophageal cancer with stenosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024262
Enrollment
Unknown
Registered
2019-07-03
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Advanced esophageal cancer

Interventions

Experimental group:Stent implantation plus drug-loaded microspheres for esophageal cancer
Control group:Stent implantation for esophageal cancer

Sponsors

Department of Gastroenterology, Xinqiao Hospital, Affiliated to Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old; 2. Men and women are not limited, squamous cell carcinoma; 3. Definitely diagnosed as esophageal cancer with stenosis, failed by standard first-line treatment, esophageal mediastinal CT scan + enhancement, total abdominal CT scan + enhancement, electrocardiogram, echocardiography, blood routine + reticulum, liver function, Kidney function, electrolytes, coagulation six, fecal occult blood test, weight. CT assessment of lesions without distant metastatic patients; 4. patients who cannot be surgically removed or who are not willing to undergo surgery; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women, or female patients with a birth plan during the study period; 2. complicated with severe cardiovascular disease (heart function greater than grade II), hemorrhagic disease (coagulation abnormality, PT>16S, APTT>43S, INR>2), liver function (ALT and AST>2ULN, TBIL>1.5ULN ), cases of abnormal renal function (creatinine > 1.5ULN); 3. Patients with mental illness; 4. taking drugs that affect coagulation function (such as non-steroidal anti-inflammatory drugs, adrenal corticosteroids, anticoagulants, aspirin); 5. Patients who are allergic to the drug used in this study; 6. participated in other drug research in the first three months; 7. Cachexia US Eastern Cancer Research Assistance Group (ECOG) physical status score > 3 points, Karnofsky behavior status (KPS) score <= 60 points, estimated survival is less than 2 months; 8. Reluctant to join the trial, refuse to sign informed consent or comprehensively judge cases with poor compliance.

Design outcomes

Primary

MeasureTime frame
Solid tumor size;

Countries

China

Contacts

Public ContactYingbing Zhao

Xinqiao Hospital of Army Military University

527365196@qq.com+86 13452876296

Outcome results

None listed

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