A single center and single arm study for personalized neoantigen peptides vaccine in the treatment of advanced colorectal cancer

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900022372

Enrollment

Unknown

Registered

2019-04-08

Start date

2018-12-01

Completion date

Unknown

Last updated

2019-04-15

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

Conditions

Colorectal Cancer

Interventions

Case series:Case series

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients volunteer to join in the trial and sign the informed consents; 2. Adult patients aged 18 to 75 years old, no gender limitation; 3. Histologically confirmed colorectal cancer, TNM stage IIIb-IV; 4. chemoradiotherapy are ineffective, or chemotherapy is not effective and is not suitable or unwilling to receive radiotherapy, and is not willing to receive other immunotherapy.; At least one site measurable by image examination; 5. with an anticipated life expectancy of 3 months or longer; 6. Hematology Indexes: Serum creatinine = 1.5 × upper limit.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × ULN; creatinine clearance (CrCl) = 60 mL/min

Exclusion criteria

Exclusion criteria: 1. Known human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection, or uncontrolled coronary artery diseases, uncontrolled asthma, uncontrolled cerebrovascular diseases, or any other diseases in the opinion of the investigator would compromise study administration; 2. Previous bone marrow transplantation or organ transplantation; Coagulation disorders; 3. History of pre-existing immunodeficiency disorders, or autoimmune diseases; 4. Received any other immunotherapy within the last 30 days; 5. Potential allergic reactions for immunotherapy; 6. Drug abuse or alcohol or any clinical or psychological or social factors affect informed consent or research implementation; 7. Pregnant or nursing woman; 8. Currently participating or participated other clinical studies within the last 1 weeks; 9. Any underlying conditions that were unsafe for patients or would compromise study administration; 10. Patients with secondary brain metastases.

Design outcomes

Primary

Measure	Time frame
Safety Index;ORR;PFS;OS;immune indexes;EORTC QLQ-C30 V3.0;DCR;	—

Countries

China

Contacts

Public ContactZhenzhai Cai

czz77@sina.com+86 13868809190

Outcome results

None listed

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