A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01

Korábbi kezelés

• Previous pelvic or abdominal radiotherapy.
• Previous total or partial hysterectomy.
• Combination of preoperative radiotherapy with surgery.
• Patients receiving neo-adjuvant chemotherapy or non-protocol antineoplastic treatment apart from weekly cisplatin (40 mg/m2).
• Participation in another clinical trial with an investigational drug, device or biologic within the preceding 3 months, except an observational study.

Más betegség

• Other primary malignancies except basal cell carcinoma of the skin.
• Anatomical location and/or extent of disease difficult to access for safe intratumoral drug injections.
• Contraindications to the pelvic radiation such as inflammatory bowel disease and collagen vascular disease.
• High medical risks because of non-malignant systemic disease or with active uncontrolled infection.

Egyéb

• Histologically diagnosed small cell (neuroendocrine), melanoma, clear cell and other rare variants of the classical adenocarcinoma at cervices.
• Contraindications to MRI.
• Patients on anticoagulants or deranged coagulation profile.
• Pregnancy or nursing.

• Provide written informed consent before participation.
• Female subjects age 18 years or older.
• Histologically diagnosed squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.
• FIGO stage II and III locally advanced cervical cancer.
• No evidence of metastatic disease.
• At least one tumor that qualifies as a Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 tumor with tumor size >5 cm diameter, not previously irradiated, at baseline assessed [by magnetic resonance imaging (MRI)] within 28 days before Day 1.
• No prior chemotherapy or radiotherapy for cervical cancer.
• Intention to undergo treatment including EBRT with 5 cycles of cisplatin followed by BT; to be completed within 8 weeks of its initiation.
• Patients with predicted life expectancy of 3 months or more.
• Target tumor is accessible for intratumoral injection.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Negative pregnancy test before start of CRT in women of childbearing potential and an ability/willingness to protect against pregnancy from consent and for 3 months post-RT.