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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • QL1706 Plus Lenvatinib

    Drug

    All 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

30 Participants
are divided into 1 treatment group
Group A: QL1706 plus lenvatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants who obtain a major pathologic responses (MPR)

Time frame
3 years

Secondary outcomes

1

Percentage of participants who obtain a pathologic complete response (CR).

Time frame
4 years
2

Percentage of participants who obtain R0 resection.

Time frame
4 years
3

Event-Free Survival(EFS)

Time frame
4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: