Lenvatinib Combined with Tislelizumab and TACE Applied As Neoadjuvant Regimen for the Patients of CNLC Stage IB and IIA Hepatocellular Carcinoma with High Risk of Recurrence: Study Protocol of a Monocenter, Single-arm, Open Label Clincal Trail

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a monocenter, single-arm, open-label study to evaluate the efficacy and safety of Lenvatinib combined with Tislelizumab and TACE applied as neoadjuvant regimen for the patients of CNLC stage IB and IIA hepatocellular carcinoma with high risk of recurrence Primary outcome: Major pathological response (MPR) Secondary outcomes: pathological complete response (pCR), R0 resection rate, objective response rate (ORR), disease control rate (DCR), treatment-related adverse events (TRAE)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18-75 years old (inclusive);

• HCC is confirmed by preoperative pathological examination or meet the criterion of diagnosis and treatment norms of primary HCC issued by health commission, PRC. No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC;

• Patients with CNLC IB or IIA stage tumors before surgery and meeting the following conditions: radiological evaluation shows narrow or none surgical margins, and preoperative tumor markers AFP+PIVKA is greater than 1600.

• ECOG score of 0 before the first administration of the study drug;

• Child-Pugh scores is 5-6 points and liver function is grade A;

• Expected survival time of at least 16 weeks;

• Pre-administration organ function levels meet the requirements and are tolerant of surgery. The functional indicators of important organs meet the following requirements: hemoglobin ≥90g/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L; aspartate aminotransferase or alanine aminotransferase ≤5 times the upper limit of normal (ULN), alkaline phosphatase ≤2.5 ULN, serum albumin ≥30g/L; serum creatinine \<1.5 ULN; international normalized ratio (INR) ≤2 or prothrombin time (PT) within the upper limit of normal range ≤6 seconds; serum creatinine ≤1.5 ULN, creatinine clearance rate ≥60 mL/min.

• Male and female participants of childbearing potential must agree to use effective contraception throughout the study period;

• Sign an informed consent form and agree to provide previously stored tumor tissue specimens or fresh biopsy specimens of the tumor lesion.

Locations
Other Locations
China
1# Banshan East Rd. Zhejiang cancer hospital
RECRUITING
Hangzhou
Contact Information
Primary
Yuhua Zhang, MD
drzhangyuhua@126.com
+86-0571-88128058
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 35
Treatments
Experimental: Experimental
1. TACE: pharmorubicin 30mg, oxaliplatin 50mg, cycle 4-5 week.~2. Tislelizumab: 200mg, cycle 3 week.~3. Lenvatinib: weight \<60kg, 8mg/day; weight ≥60kg, 12mg/day.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Cancer Hospital

This content was sourced from clinicaltrials.gov