Buscador de ensayos clínicos

Criterios de inclusión

Criterios de inclusión:

1. Male or female ≥18 years of age.
2. Histological or cytologic diagnosis of colorectal adenocarcinoma that is unresectable or metastatic.
3. Have had disease progression or were intolerant to treatment protocols that included irinotecan and oxaliplatin. Epidermal growth factor receptor (EGFR) or vascular endothelial growth factor receptor (VEGFR) directed therapies are allowed as part of the previous therapy if indicated.
4. Has at least 1 measurable tumor of ≥1 cm in longest diameter (or ≥1.5cm shortest diameter for lymph nodes).
5. Has injectable tumor(s) of at least 1cm in aggregate total diameter.
6. Must be willing to consent to provide archival tumor biopsy samples obtained within 90 days prior to Screening, or a fresh tumor biopsy collected on Day 1 of treatment or earlier.
7. Has adequate hematologic function, including:

* White blood cell count ≥2.0 × 10^9/L
* Absolute neutrophil count ≥1.5 × 10^9/L
* Platelet count ≥75 × 10^9/L
* Hemoglobin ≥8 g/dL(transfusions allowed; however, patient must not be transfusion-dependent).
8. Has adequate hepatic function, including:

* Total bilirubin ≤1.5 × upper limit of normal (ULN; except patients with Gilbert syndrome or liver metastases, who must have a total bilirubin of <2.0 × ULN)
* Serum albumin ≥2.8 g/dL
* Aspartate aminotransferase and alanine aminotransferase (ALT)≤3.0 × ULN (or ≤5.0 × ULN, if liver metastases are present).
9. Has adequate renal function, defined as serum creatinine ≤1.5 × ULN or creatinine clearance ≥30 mL/minute (measured using Cockcroft-Gault formula or by 24-hour urine collection).
10. Prothrombin time ≤1.5 × ULN (or international normalization ratio [INR] ≤1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN.

Note: Patients who are on chronic anticoagulant therapy may be enrolled if the pretreatment INR<2.5. For patients requiring a deep injection of RP2/RP3, the INR must be