About this trial
This is a single-center, single-arm, prospective trial to explore the efficacy and safety of neoadjuvant treatment with Iparomlimab and Tuvonralimab Injection combined with lenvatinib in patients with advanced HCC
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and ≤ 75 years;
Confirmed by pathological or imaging diagnosis as CNLC Ib/IIa/IIb/IIIa HCC (fibrotic plate and mixed hepatocellular/cholangiocarcinoma subtypes do not meet the inclusion criteria);
Patients who have not received surgery or systemic treatment before enrollment and have experienced recurrence within 2 years after surgery can be included;
MDT team determines that HCC with high-risk factors for recurrence (such as macroscopic cancer thrombus, multiple tumors, satellite nodules, tumor diameter > 5 cm, imaging vascular invasion or preoperative AFP > 200 U/ml) is resectable;
Disqualifiers
Pregnant or lactating women;
Patients with imaging evidence showing portal vein tumor thrombus reaching Vp3 or Vp4;
Patients who have received PD-1 antibody, PD-L1 antibody, CTLA-4 antibody or lenvatinib before; those who participated in other clinical trials within 30 days before screening;
Patients with active tuberculosis infection. Those who have active pulmonary tuberculosis within 1 year before enrollment; those who have had active tuberculosis infection for more than 1 year before enrollment and have not received regular anti-tuberculosis treatment or tuberculosis is still active;
Trial design
Single group
Treatments tested in this trial
QL1706 Plus Lenvatinib
DrugAll enrolled subjects will receive QL1706 5 mg/kg intravenously plus lenvatinib 8/12mg on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles).
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants who obtain a major pathologic responses (MPR)
Secondary outcomes
Percentage of participants who obtain a pathologic complete response (CR).
Percentage of participants who obtain R0 resection.
Event-Free Survival(EFS)
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: