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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT01443260
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of histologically or cytologically documented, advanced stage of peritoneal carcinomatosis that is refractory to standard therapy, exhibiting a likely survival of \> 4 months as being judged clinically.
2. Evidence of measurable disease.
3. Age ≥ 18 years.
4. ECOG (Eastern Cooperative Oncology Group Performance Status) ≤ 2.
5. Required baseline laboratory data include:
* Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
* Platelets ≥ 75 ×109/L
* Haemoglobin ≥ 9.5 g/dL
* Serum creatinine ≤ 2 × upper limit of normal(ULN)
* Total Bilirubin ≤ 5 × ULN
* AST/ALT ≤ 7.5 × ULN
* Negative pregnancy test for females of childbearing potential
* Serum albumin ≥ 2.5 g/dL.
* If serum albumin level is \< 2.5/dL,albumin substitution should take place until the threshold of ≥ 2.5 g/dL.
6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, implantation of the indwelling peritoneal catheter, as well as the respective drainage procedures.
7. All patients must agree to use highly effective contraception.
Exclusion Criteria:
1. Patients exhibiting objective evidence at baseline of brain metastases are excluded from participating.
2. Pregnant or breast-feeding women.
3. Primary tumors and metastases to tissues/organs which, under clinical judgment, will likely hinder survival for at least the next 4 months.
4. Patients with fever, any active immunosuppressive systemic infection or a suppressed immune system, including known HIV, as assessed within 14 days prior to study enrolment.
5. Concurrent vaccination or immunotherapy for 28 days before study therapy and during study treatment.
6. Patients on immunosuppressive therapy or with immune system disorders, including autoimmune diseases. Concurrent steroid use of not more than an equivalent of 20 mg/day prednisolone is allowed.
7. Prior splenectomy.
8. Previous organ transplantation.
9. Fully therapeutic coagulation therapy that does not allow the intraperitoneal insertion of a permanent catheter.
10. Patients with clinically significant dermatological disorders(e.g., eczema or psoriasis), any skin lesions or ulcers, any history of atopic dermatitis, or any history of Darier's disease (Keratosis Follicularis).
11. Clinically significant cardiac disease (New York Heart Association, Class III or IV: see Appendix 10)
12. Known allergy to ovalbumin or other egg products.
13. Concurrent use of antiviral agents active against vaccinia virus.
14. Prior gene therapy treatment or prior therapy with cytolytic virus of any type.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01443260
Study Brief:
Protocol Section:
NCT01443260