Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib as Second-line or Later Therapy in Patie… (NCT05675462) | Clinical Trial Compass
UnknownPhase 1
Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib as Second-line or Later Therapy in Patients With Advanced Hepatocellular Carcinoma
China25 participantsStarted 2023-03-01
Plain-language summary
The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab plus lenvatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained.
✓. Age ≥ 18 years at time of study entry.
✓. Participants must have unresectable or metastatic histologically or cytologically confirmed hepatocellular carcinoma.
✓. Participants must have failed 1 line of systemic regimens for advanced hepatocellular carcinoma due to disease progression or toxicity.
✓. Patients had been refractory or intolerant to previous systemic chemotherapy (oxaliplatin-based chemotherapy), targeted therapy (eg, sorafenib or lenvatinib), or anti-PD-1 or anti-PD-L1 based regimen.
✓. At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
✓. Performance status (PS) ≤ 2 (ECOG scale).
✓. Life expectancy of at least 12 weeks.
Exclusion criteria
✕. History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
✕. Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
✕. RFA and resection administered less then 4 weeks prior to study treatment start.
. Radiotherapy administered less then 4 weeks prior to study treatment start.
✕. Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
✕. Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
✕. Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
✕. Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.