Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT07002203
Eligibility Criteria:
Inclusion Criteria:
1. Age: 20 years or older.
2. Language proficiency: Able to read and understand Thai clearly.
3. Consent: Willing to provide informed consent and sign a participation agreement.
4. Life expectancy: Estimated to be at least 6 months from the date of consent.
5. Eligibility from prior research: Must have participated in the SQK01-002A research project and have tumor tissue confirmed as suitable for neoantigen peptide vaccine production.
6. Performance status: ECOG performance status of 0-2 with stable organ function, no rapid disease progression, or impending organ failure.
7. Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence.
8. Cancer stage-specific criteria:
i. Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and shows resistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria.
ii. Early-stage cancer: High recurrence risk despite prior surgery and/or radiotherapy, with no current adjuvant treatment standard.
9. Laboratory parameters:
i. Lymphocyte count ≥ 800 cells/μL. ii. Neutrophil count ≥ 1,500 cells/μL. iii. Platelet count ≥ 75,000 cells/μL. iv. AST ≤ 2.5 times the upper limit of normal (ULN). v. ALT ≤ 2.5 times ULN. vi. Total bilirubin ≤ 1.5 times ULN. vii. Serum creatinine ≤ 1.5 times ULN.
10. Consent to Avoid Pregnancy or Causing Pregnancy Under the Following Criteria i. Female participants not of reproductive age, defined as having undergone a hysterectomy and/or bilateral oophorectomy, experiencing continuous menopause for more than 12 months, or being over 60 years of age.
ii. Female participants of reproductive age must undergo a pregnancy test and have a confirmed negative result during the preparation phase and before the first day of vaccination. They must also consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and follow-up, and up to 120 days after the final treatment.
iii. Male participants must consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and up to 120 days after the final treatment.
Exclusion Criteria:
1. History of hypersensitivity to peptide vaccines or related substances.
2. Autoimmune disease history.
3. Previous treatments that significantly suppress or impair immune function.
4. Refusal of current standard-of-care treatment.
5. Active brain or central nervous system metastases unless well-controlled with steroids ≤ 10 mg/day prednisolone.
6. Presence of more than one active cancer type.
7. Uncontrolled cardiac conditions, such as unstable angina or advanced heart failure (NYHA Class III/IV).
i. Participants with pacemakers may be eligible if stabilized for at least 1 month before vaccination.
8. Receipt of any other vaccines within 28 days before the first neoantigen peptide vaccine.
9. Participation in another clinical trial.
10. Use of immunosuppressive drugs or steroids \> 10 mg/day prednisolone (except inhaled/intranasal corticosteroids).
11. Pre-existing conditions that could compromise the efficacy or safety of the peptide vaccine.
12. Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT07002203
Study Brief:
Protocol Section:
NCT07002203