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Phase I clinical trial of personalized neoantigen peptides combined with seed implantation in the treatment of advanced chest malignant tumor

Phase I clinical trial of personalized neoantigen peptides combined with seed implantation in the treatment of advanced chest malignant tumor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16010125
Enrollment
Unknown
Registered
2016-12-11
Start date
2017-01-01
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Chest malignant tumor

Interventions

Control group:125I need implantation therapy
Study group:125I need implantation therapy combined with personalized neoantigen peptides once a week, 12 weeks for a course of treatment

Sponsors

Tianjin Beichen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patients with stage III/IV breast malignant tumors with an estimated survival of more than 3 months; 2.There are lesions that can be implanted with 125I seed implantation; 3.PS score 3-4; 4.More than one gene mutation is can be used to design personalized neoantigen peptides; 5.No previous neoantigen immunotherapy.

Exclusion criteria

Exclusion criteria: 1.Pregnancy or lactation woman; 2.Patients with known or suspected autoimmune disease or other complicated immune system disease; 3.Patients with liver and kidney dysfunction, severe heart disease, coagulation dysfunction and hematopoietic impairment; 4.Patients with systemic infections; 5.Any disease, treatment, laboratory examination abnormality or medical history that may affect the participants' inability to participate in the entire study.

Design outcomes

Primary

MeasureTime frame
safety;

Secondary

MeasureTime frame
Immunological indexes;disease control rate;Progression-free survival;Overall survival;

Countries

China

Contacts

Public ContactXueming Du

Tianjin Beichen Hospital

dudaming73@163.com+86 13752713866

Outcome results

None listed

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