Clinical Study of a Personalized Neoantigen Vaccine in Esophagus Cancer Patients Who Have Completed Adjuvant Therapy Following Neoadjuvant Therapy and Surgical Resection

Status: Active_not_recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This research study is evaluating a new type of esophagus cancer vaccine called Personalized Neoantigen Cancer Vaccine as a possible treatment for esophagus cancer patients who have completed adjuvant therapy following neoadjuvant therapy and surgical resection. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of resectable esophagus cancer, so as to provide a new personalized therapeutic strategy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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⁃ Must freely sign informed consent;

⁃ Aged 18 to 80 years old;

⁃ Histologically or cytologically confirmed diagnosis of esophagus cancer;

⁃ ECOG score is 0 or 1;

⁃ completed Neoadjuvant combined with PD-1 therapy ;Completed surgical resection ;At the same time, standard postoperative treatment was performed 8 \

• 12 weeks of therapy;

⁃ Must provide all exons of tumor tissue sequencing data, transcriptome sequencing data and the peripheral blood of all exons sequencing data;

⁃ Completion of imaging records 1 week before personalized immunotherapy, including but not limited to full-body PET-CT and brain MRI,

⁃ Haematological index: White blood cells ≥ 3500 / MCL; Lymphocytes \> 800/ MCL; neutrophils \> 1500/ MCL; Platelets \> 100000 / MCL; Hemoglobin \>10.0g/dL; Total serum bilirubin \<1.5× upper limit of normal value (ULN); AST/ALT\<2.0 times the upper limit of normal; Serum creatinine \<1.5 times the upper limit of normal;

⁃ Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;

‣ Male patients are willing to take appropriate methods of contraception;

‣ Good compliance, able to follow research protocols and follow-up procedures;

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University
Hangzhou
Time Frame
Start Date: 2021-12-02
Completion Date: 2026-12-31
Participants
Target number of participants: 27
Treatments
Experimental: Personalized neoantigen vaccines
iNeo-Vac-P01 (peptides): 300 mcg per peptide
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Hangzhou Neoantigen Therapeutics Co., Ltd.

This content was sourced from clinicaltrials.gov

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