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Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms

A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms

NCT06026800•Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 in combination with first-line treatment in subjects with advanced digestive system neoplasms.

Detailed Description

This is a single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 in combination with first-line treatment in subjects with advanced digestive system neoplasms.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, \>/= 18 years old and \</= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.

Exclusion Criteria

•3. Expected survival \>/= 6 months.
•4. ECOG performance status score of 0 \~ 1.
•5. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture samples and at least 0.5cm of tissue required for surgical samples. Alternatively, the original gene sequencing data required for tumor neoantigen analysis can be provided, including full exon sequencing data of tumor tissue, transcriptome sequencing data, and full exon sequencing data of peripheral blood.
•6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \>/= 50%.
•7. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \>/= 1.5 × 10\^9/L, platelet count (PLT) \>/= 80 × 10\^9/L, hemoglobin (Hb) \>/= 90 g/L; serum total bilirubin (TBIL) \</= 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \</= 2.5 × ULN (if there is liver metastasis, TBIL \</= 3 × ULN, AST, ALT \</= 5 ×ULN are allowed), serum albumin \>/= 28g/L, serum creatinine \</= 1.5 × BUN, Glomerular filtration rate \>/= 50mL/min, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \</= 1.5 × ULN (without anticoagulant therapy) .
•8. For women of childbearing potential: having a negative serum or urine pregnancy test within 7 days prior to study initiation, agreement to remain abstinent or use contraceptive measures during the treatment period.
•9. For men: agreement to remain abstinent or use contraceptive measures during the treatment period.
•1. Subjects with cancer requiring anti-tumor treatment within the 5 years prior to enrollment in the study (except stage I prostate cancer, cervical cancer in situ, breast cancer in situ, papillary thyroid cancer and non-melanoma skin cancer that have been treated).
•2. Subjects who received major surgery, or had obvious traumatic injury or long-term untreated wounds or fractures within 2 weeks prior to the first dose of iNeo-Vac-R01.
•3. Subjects whose sequencing data was found that there are no new antigens available for individualized immunotherapy after analysis.
+14 more criteria

Locations (1)

Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Key Dates

Start Date

September 8, 2023

Primary Completion Date

August 31, 2027

Completion Date

December 31, 2027

Last Updated

September 11, 2023

Enrollment

ESTIMATED participants

Conditions

Digestive System Neoplasms

Interventions

iNeo-Vac-R01

BIOLOGICAL

Contacts

Xiujun Cai, MD

CONTACT

0086-0571-86006605 caixiujunzju@yahoo.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Combination With Standard First-line Treatment in Subjects With Advanced Digestive System Neoplasms

Inclusion Criteria

Exclusion Criteria

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