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IntraDose in unresectable primary hepatocellular carcinoma
NCT00003044Phase 2
Key facts
- Status
- Unknown
- Start
- Sep 1996
- Countries
- 2
- Sponsor
- Matrix Pharmaceutical
- Modality
- Small Molecules
- Conditions
- hepatocellular carcinoma (HCC)
01
Overview
Phase 2, open-label, single-arm trial of cisplatin + epinephrine in hepatocellular carcinoma (HCC), sponsored by Matrix Pharmaceutical. Primary endpoints: Tumor Response (Complete or Partial) at 8 weeks and Increase in Tumor Necrosis at 8 weeks. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Single Arm
Patients receive intratumoral treatment with cisplatin-epinephrine injectable gel (IntraDose).
03
Who it enrols
Adults aged 18 and over with unresectable primary hepatocellular carcinoma confined to the liver. Patients must have no more than 3 tumors, with none exceeding 7 cm in diameter, a Karnofsky performance status of 40-100%, Child-Pugh grade A or B, and adequate organ function. Prior systemic therapies for HCC were not allowed.
04
Endpoints
Primary
Tumor Response (Complete or Partial)
Increase in Tumor Necrosis
Secondary
Overall Survival
Adverse Events
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