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Prospective, single-arm, single-center, small-sample clinical study of methotrexate-packaging microparticles in the treatment of rectal cancer by intratumoral injection

Prospective, single-arm, single-center, small-sample clinical study of methotrexate-packaging microparticles in the treatment of rectal cancer by intratumoral injection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022650
Enrollment
Unknown
Registered
2019-04-20
Start date
2019-05-06
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Rectal cancer

Interventions

Case series:Intratumoral injection of methotrexate-packaging microparticles

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Potential patients with stage IV sigmoid-rectal cancer diagnosed by pathology or cytology or clinical examination; 2. Potential patients who failed or relapsed under the standard treatment regimen or who refused the standard treatment for their own reasons; 3. Stable vital signs, Karnofsky = 60 points; 4. Patients aged 18 to 70 years; 5. Prothrombin function is generally normal (prothrombin international standardized ratio 4.0 × 10^9/L, PLT > 80 × 10^9/L; liver function: ALT and AST = 2 times ALT/AST normal value upper limit; kidney function: BUN and Cr = 1.5 times normal upper limit (ULN) or creatinine clearance = 60 mL/min; 6. Patients or family members agree to join the group and sign informed consent form.

Exclusion criteria

Exclusion criteria: Patients can not enter or continue research if they have one of the following conditions: 1. Women who are breastfeeding, pregnant or preparing for pregnancy; 2. Patients with allergic constitution and drug allergy; 3. Potential patients with severe primary diseases such as cardio-cerebrovascular, liver, kidney, hematopoietic system and psychiatric disorders; 4. Patients with severe infection; 5. Participants of other clinical trials within the past four weeks.

Design outcomes

Primary

MeasureTime frame
Imaging evaluation of changes in lesion diameter;Tumor markers;

Secondary

MeasureTime frame
Quality of life;Survival period;

Countries

China

Contacts

Public ContactQiu Zhao

Zhongnan Hospital of Wuhan University

qiuzhao@whu.edu.cn+86 13971605755

Outcome results

None listed

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