An Exploratory Clinical Study on Neoadjuvant Treatment of Hepatocellular Carcinoma with QL1706 Combined with Lenvatinib

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNorthern Jiangsu People's Hospital

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

Qualifiers

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

Treatments tested in this trial

  • QL1706 Plus Lenvatinib

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations