Esophageal cancer Esophageal cancer
Conditions
Interventions
Sponsors
Hara Ken-ichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following items at the time of primary confirmation of eligibility will be eligible for this clinical trial. 1) Subjects who have received sufficient explanation about the contents of this trial and have given their written consent to participate in this trial 2) Subjects with curatively unresectable advanced or recurrent esophageal squamous cell cancer 3) Age at the time of informed consent: 18 to 74 years old 4) ECOG Performance Status (PS) at within 2 weeks from the time of informed consent: 0 or 1 5) Subjects with life expectancy at least 6 months at the time of informed consent 6) Subjects who are able to provide a sufficient amount of tumor tissue specimen and collect peripheral blood Subjects who meet all of the following items at the time of secondary confirmation of eligibility will be eligible for this trial. 1) Subjects have given their written consent to continue this trial 2) Subjects with advanced or recurrent esophageal squamous cell carcinoma who are unresponsive or intolerant to standard treatments and who are unresectable 3) Subjects aged 75 years or younger at the time of secondary confirmation of eligibility 4) Subjects with lesions that can be evaluated by imaging test within 4 weeks before secondary confirmation of eligibility 5) Subjects with ECOG PS of 0 or 1 within 2 weeks prior to secondary confirmation of eligibility 6) Subjects with 5 or more types of neoantigen peptides as a result of neoantigen analysis and neoantigen peptide synthesis during the screening period 7) Subjects met with following laboratory tests. WBC >= 3,000/mm^3 Neutrophil >= 1,000/mm^3 Hemoglobin >= 9.0 g/dL Platelet>=10 x 10^4/mm^3 Total bilirubin Subjects who meet all of the following criteria at the time of treatment transition will be included in this clinical trial. 1) Subjects who have given written informed consent to continue in this clinical trial 2) Subjects with ECOG PS of 0 or 1 within 2 weeks prior to the treatment transition
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria at the time of initial enrollment will be excluded from this clinical trial. 1) Subjects with systemic and active infections that are difficult to control (requiring systemic antibiotics, antifungals, or antivirals) 2) Subjects with synchronous or metachronous tumors other than esophageal cancer, or patients whose tumors have been cured but whose disease-free period has been less than 2 years (However, patients with intraepithelial or intramucosal cancer of the stomach or large intestine who can be judged to have been completely cured by endoscopic submucosal dissection (ESD), or patients with skin cancer who can be judged to have been completely cured by resection may be included) 3) Subjects with severe or difficult-to-control complications such as liver disease, kidney disease, heart disease, lung disease, brain disease, blood disease, or metabolic disease. 4) Subjects who are scheduled to receive any anti-cancer treatment during the main observation period or follow-up period 5) Subjects with a history of hypersensitivity to the bovine-derived ingredients, human serum albumin, human holotransferrin, HEK293 cells, and DMSO (dimethyl sulfoxide) which are used in the manufacture of the product, or subjects with drug allergies or a history of such allergies. 6) Subjects with a history of immunotherapy (tumor vaccines, cytokines, etc.) (excluding those with a history of immune checkpoint inhibitor treatment) 7) Subjects who are receiving other investigational products or investigational drugs (including clinical trial drugs) at the time of obtaining consent 8) Subjects who have previously undergone an organ transplant or who are scheduled to undergo an organ transplant during the clinical trial period 9) Female subjects who are pregnant, breastfeeding, or hoping to become pregnant between the time of obtaining informed consent and the end of the follow-up period, or female subjects who cannot agree to use highly effective contraception under the guidance of a doctor during the above period (even if breastfeeding, patients may be enrolled if they discontinue breastfeeding. However, breastfeeding is prohibited during the main observation period). 10) For male subjects, subjects who cannot agree to use highly effective contraception under the guidance of a doctor from the time of obtaining informed consent until the end of the follow-up period 11) Subjects who are otherwise deemed inappropriate for this clinical trial by the principal investigator or clinical investigator. Subjects who meet any of the following criteria at the time of secondary confirmation of eligibility will be excluded from this clinical trial. 1) Subjects with systemic and active infections that are difficult to control (requiring systemic antibiotics, antifungals, or antivirals) 2) Subjects with synchronous or metachronous tumors other than esophageal cancer (However, patients with intraepithelial or intramucosal cancer of the stomach or large intestine who can be judged to be completely cured by ESD, or patients with skin cancer who can be judged to be completely cured by resection may be included) 3) Subjects with severe or difficult-to-control complications such as liver disease, kidney disease, heart disease, lung disease, brain disease, blood disease, or metabolic disease. 4) Subjects who are scheduled to receive any of the following treat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) DLT, MTD 2) Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) ORR, DCR, Best Overall Response (BOR) 2) PFS, OS 1) Neoantigen peptide-specific IFN-gamma producing cells in peripheral mononuclear cells 2) Changes in tumor markers (SCC antigen, CYFRA, anti-p53 antibody) 3) T-cell receptor repertoire analysis | — |
Contacts
Public ContactKen-ichiro Hara
NPT CO., LTD.
Outcome results
None listed