Tislelizumab Monotherapy or Combined With Lenvatinib as Neoadjuvant Therapy for Resectable Hepato… (NCT05807776) | Clinical Trial Compass
CompletedPhase 2
Tislelizumab Monotherapy or Combined With Lenvatinib as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma.
China36 participantsStarted 2023-04-24
Plain-language summary
This is a phase II prospective study to evaluate the safety and efficacy of Tislelizumab monotherapy or combined with lenvatinib as neoadjuvant therapy for resectable hepatocellular carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients must have a known diagnosis of HCC as defined in the protocol
✓. Patients must be evaluated by the Department of Hepatobiliary Oncology, Tianjin Medical University Cancer Hospital to determine whether they can complete surgical treatment. Patients can be resectable in both oncology and surgery.
✓. At least ≥1 measurable lesion (RECIST 1.1)
✓. Age 18-75, male or female
✓. ECOG PS 0-1
✓. Child-pugh A
✓. The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days)
✓. Normal coagulation function, International standardized ratio INR≤1.5×ULN or Prothrombin time PT≤1.5ULN
Exclusion criteria
✕. Have received any systemic anticancer therapy or radiotherapy for their current tumor or other primary tumor in the 6 months prior to study entry.
✕. Tumor load or tumor growth rate was considered by the investigator to be insufficient to delay surgery.
✕. Had major surgery within 14 days prior to neoadjuvant therapy.
✕. Uncontrolled co-morbidities defined in the protocol and identified by the investigator.
What they're measuring
1
MPR rate
Timeframe: 4 months
Trial details
NCT IDNCT05807776
SponsorTianjin Medical University Cancer Institute and Hospital