AzTrials
AzTrials

HCC - Hepatocellular CarcinomaPhase 2NCT06884982

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

A Phase 2 study testing QL1706 Plus Lenvatinib in people with HCC - Hepatocellular Carcinoma, run by Northern Jiangsu People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC - Hepatocellular Carcinoma
What is being tested?
QL1706 Plus Lenvatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
13 Mar 2025to 30 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • Positive hepatitis B surface antigen, no restrictions on anti-hepatitis B virus treatment;
  • At least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) evaluated by the investigator;
Show all 11Show fewer
  • Organ function levels must meet the following requirements: i. Adequate bone marrow reserve: absolute neutrophil count >= 1.5 x 10^9/L, white blood cell count >= 3 x 10^9/L, platelet count >= 90 x 10^9/L, and hemoglobin >= 9 g/dL; ii. Liver: plasma albumin >= 2.8 g/dL; for patients without liver metastasis, serum bilirubin <= 2xULN, and for patients with liver metastasis, serum bilirubin <= 3xULN; for patients without liver metastasis, AST and ALT <= 2.5xULN, and for patients with liver metastasis, AST and ALT <= 5xULN; iii. Kidney: serum creatinine <= 1.5xULN; iv. Heart: left ventricular ejection fraction (LVEF) >= 50% (no blood transfusion, no use of hematopoietic growth factors and human albumin within 14 days before screening);
  • Non-surgical sterilized female or male subjects of childbearing age, must agree to use a medically approved contraceptive method (such as intrauterine device, contraceptive pills or condoms) for contraception during the study treatment period and within 6 months after the end of the study treatment period; for non-surgical sterilized female subjects, the HCG test must be negative within 7 days before enrollment and must not be lactating;
  • Child-Pugh: A/B grade (<= 7 points);
  • ECOG performance status 0-1;
  • Expected survival >= 6 months.

Who cannot join

  • 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;
  • Patients with gastrointestinal malabsorption, gastrointestinal anastomosis or any other conditions that may affect the absorption of lenvatinib;
  • Patients with NYHA II grade or above congestive heart failure history, unstable angina pectoris, myocardial infarction within 6 months or severe arrhythmia with significant cardiovascular damage within 6 months;
Show all 16Show fewer
  • Within 3 weeks before the first administration of the study drug, patients have experienced gastrointestinal bleeding events or active hemoptysis (at least 0.5 teaspoons of bright red blood);
  • Patients with bleeding or thrombotic diseases or using X-factor inhibitors or anticoagulants that require monitoring of the international normalized ratio (INR), such as warfarin or similar drugs. Low molecular weight heparin treatment is allowed. Antiplatelet drugs at the treatment dose (such as aspirin ≥ 325 mg/d) are not allowed to be used during the study process;
  • Patients who require immunosuppressive therapy after organ transplantation; patients who have received immunosuppressive drugs or systemic corticosteroids to achieve immunosuppression purposes within 14 days before enrollment (such as > 10 mg/day prednisone or equivalent drugs);
  • Patients with active ulcers, unhealed wounds or fractures;
  • Patients with hypertension and poor control of blood pressure (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg);
  • Patients known to be allergic to any trial drug or excipients;
  • Patients who have had other malignant tumors that have not been cured for more than 5 years, but do not include clearly cured malignant tumors, or curable cancers, such as basal cell carcinoma or squamous cell carcinoma of the skin, papillary thyroid carcinoma, localized low-risk prostate cancer, cervical carcinoma in situ or breast carcinoma in situ, etc.;
  • Patients who have received allogeneic tissue/organ transplantation;
  • Patients with known HIV infection history;
  • According to the investigator's judgment, the subjects have other factors that may affect the trial results or cause the study to be forced to stop prematurely, such as alcohol abuse, drug abuse, other serious diseases (including mental diseases) that require combined treatment, severe laboratory test abnormalities, and factors affecting the patient's safety due to family or social factors.

About this study

Official title: An Exploratory Clinical Study on Neoadjuvant Treatment of Hepatocellular Carcinoma with Iparomlimab and Tuvonralimab Injection Combined with Lenvatinib

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

Being tested
QL1706 Plus Lenvatinib
Keywords
neoadjuvant therapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706 Plus LenvatinibDrug

    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).

Study groups in NCT06884982
Study groupRoleWhat they receive
QL1706 plus lenvatinibExperimentalNot described
Receives: Drug: QL1706 Plus Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 years

Secondary outcomes (3)

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

    Measured: 4 years

  2. Percentage of participants who obtain R0 resection.

    Measured: 4 years

  3. Event-Free Survival(EFS)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start13 Mar 2025 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06884982
Sponsor's protocol ID
2025ky032
Status last verified
Mar 2025
First submitted
13 Mar 2025
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 Plus Lenvatinib in people with HCC - Hepatocellular Carcinoma, run by Northern Jiangsu People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who obtain a major pathologic responses (MPR) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06884982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in