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A prospective, single center clinical study of neoantigen-loaded personalized dendritic cell vaccine in the treatment of spinal metastatic tumor

A prospective, single center clinical study of neoantigen-loaded personalized dendritic cell vaccine in the treatment of spinal metastatic tumor

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040158
Enrollment
Unknown
Registered
2020-11-23
Start date
2020-11-17
Completion date
Unknown
Last updated
2021-01-18

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

Conditions

Spinal metastasis

Interventions

Sponsors

Shanghai Changzheng hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-70 years old; 2) Malignant tumor spinal metastasis with obvious pain or spinal instability or spinal cord compression; 3) Spinal metastases were treated by surgery; 4) After standard chemotherapy or targeted drug therapy, the control of primary tumor is not ideal; 5) No severe cognitive impairment, no sensory aphasia, can understand the basic instructions; 6) No serious basic diseases such as cardiovascular and cerebrovascular diseases; 7) Voluntarily participated in the study and signed the informed consent; 8) The expected survival time was more than 6 months.

Exclusion criteria

Exclusion criteria: 1) With other serious heart, brain, kidney, autoimmune disease and other diseases; 2) Not eligible for treatment; 3) Albumin level was lower than 30 g/L, hemoglobin level was lower than 70 g/L, platelet was lower than 70 000 cells/ul, white blood cell was lower than 2000 cells/uL; 4) The body weight was less than 45 kg and the body mass index (BMI) was not in the range of 18-26 kg / m2.

Design outcomes

Primary

MeasureTime frame
Overall survival;Progress-free survival;

Secondary

MeasureTime frame
safety;adverse event;life quality score;

Countries

China

Contacts

Public ContactJianru Xiao

Shanghai Changzheng Hospital

liliunit@163.com+86 13701785283

Outcome results

None listed

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