ClinicalTrials.gg
Not yet recruitingNCT07933016Updated Nov 12, 2026

QL1706 and Lenvatinib Combined With FOLFOX Systemic Chemotherapy as Second-line Treatment in Advanced Hepatocellular Carcinoma Patients

A Phase 2 interventional study of Intervention 1 - Drug QL1706 (Iparomlimab and Tuvonralimab) Intervention 2 - Drug Lenvatinib Intervention 3 - Drug FOLFOX Chemotherapy (Oxaliplatin, Fluorouracil, and Levoleucovorin Calcium) in Hepatocellular Carcinoma (HCC), sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Carcinoma, Hepatocellular by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — 11 open to participants now, 11 under way, 1 of them phase 3. Carcinoma, Hepatocellular · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.

Planned enrollment
8th of 13
33 · median 52
Started
2026
with 2 others
Phase 2
7 of 16
4 open now
Primary completion
2029-12
later than 9 of 10 live
Registered
16th of 16
by date

Among the 16 studies in Carcinoma, Hepatocellular by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, this one is the 8th largest by planned enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2026, is one of 7 in phase 2, reaches primary completion later than 9 of the 10 other live ones, and was the 16th registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

11 of the 16 studies in Carcinoma, Hepatocellular by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University are open now, in 1 country. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

Where they have run

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

Liver cancer (hepatocellular carcinoma, HCC) is usually treated first with a combination of immunotherapy (drugs that help the immune system attack cancer) and targeted therapy (drugs that block signals cancer cells need to grow). However, many patients' cancer grows again after this first-line treatment, and currently available second-line single drugs shrink tumors in only about 5-15% of patients.

This study will test whether a new three-drug combination can work better as a second-line treatment. The combination includes: (1) QL1706 (iparomlimab and tuvonralimab), an investigational immunotherapy that blocks two immune "brakes" on cancer cells (PD-1 and CTLA-4) at the same time; (2) lenvatinib, an approved targeted-therapy capsule taken by mouth; and (3) FOLFOX, a standard chemotherapy combination given by infusion (oxaliplatin, levoleucovorin, and fluorouracil).

About 33 adults (18 years or older) with advanced HCC whose disease has worsened after first-line immune-targeted therapy will take part in this study at a single hospital in China. Participants will receive QL1706 by intravenous infusion once every 3 weeks, lenvatinib by mouth once daily, and FOLFOX chemotherapy every 3 weeks for up to 6 cycles. QL1706 and lenvatinib will continue as long as the cancer is controlled and side effects are acceptable, for up to 2 years.

The researchers hypothesize that the three-drug combination will shrink tumors in at least 30% of patients-clearly better than the approximately 10% response typically seen with currently available second-line single-drug treatments. The main outcome measure is the proportion of patients whose tumors shrink (objective response rate), assessed by the study doctors using standard imaging criteria (RECIST 1.1). The study uses a two-stage design: if the treatment appears ineffective after the first 10 patients are evaluated, the study will stop early.

Researchers will also measure how long the cancer stays under control, how long patients live, side effects, patients' quality of life, and whether blood markers can help predict who benefits from the treatment.

Read the detailed description

Background: First-line immune checkpoint inhibitor plus antiangiogenic targeted therapy is the standard of care for advanced hepatocellular carcinoma (HCC), but most patients eventually progress, and available second-line single agents achieve objective response rates (ORR) of only about 5%-15%. New strategies are needed for this population.

Design: This is a prospective, open-label, single-arm, single-center phase II trial at Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Approximately 33 patients will be enrolled using a Simon optimal two-stage design (null ORR 10% vs. target ORR 30%; α = 0.05; power 80%). Stage 1 will treat 10 patients; the trial stops for futility if ≤1 patient responds; otherwise enrollment proceeds to 29 evaluable patients, and 33 patients will be enrolled allowing 10% dropout.

Interventions: QL1706 (iparomlimab and tuvonralimab, a PD-1/CTLA-4 antibody combination produced by MabPair technology) 5 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle; lenvatinib 8 mg/day (body weight \<60 kg) or 12 mg/day (≥60 kg) orally once daily; and FOLFOX every 3 weeks for up to 6 cycles (oxaliplatin 85 mg/m² IV over 2 hours; levoleucovorin calcium 200 mg/m² IV; fluorouracil 400 mg/m² IV bolus followed by 2400 mg/m² continuous infusion over 46 hours). QL1706 and lenvatinib continue until RECIST v1.1-confirmed progression (patients with continued clinical benefit may continue beyond initial progression), unacceptable toxicity, withdrawal of consent, or a maximum of 2 years of treatment.

Primary endpoint: investigator-assessed ORR per RECIST v1.1. Secondary endpoints: PFS, TTP, DCR, and DoR per RECIST v1.1 and mRECIST; surgical conversion rate in initially unresectable patients; OS and 12-/24-month OS rates; safety per NCI CTCAE v5.0; health-related quality of life (EORTC QLQ-C30 and QLQ-HCC18).

Exploratory: association between baseline chemotherapy-sensitivity genes (blood samples) and efficacy.

Key eligibility: age ≥18 years; histologically/cytologically or clinically confirmed HCC; BCLC stage B or C, unsuitable for surgery or locoregional therapy; progression after at least one prior line of immune-targeted therapy; ECOG PS 0-1; Child-Pugh A or B (≤7); ≥1 measurable lesion per RECIST v1.1; adequate organ function; life expectancy ≥12 weeks.

Timeline: start December 2026; last patient in December 2028; completion December 2029 (all anticipated).

03

Conditions studied

  • Hepatocellular Carcinoma (HCC)

Keywords

  • Hepatocellular carcinoma
  • Second-line treatment
  • Phase II clinical trial
  • PD-1/CTLA-4 bispecific antibody
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient voluntarily agrees to participate in this study and provides written .
  • Age ≥ 18 years; both male and female patients are eligible.
  • or cytologically confirmed, or clinically diagnosed, hepatocellular carcinoma (HCC) prior to study treatment.
  • Barcelona Clinic Liver Cancer (BCLC) stage B or C, and unsuitable for surgery or local-regional therapy, or disease progression after surgery and/or local-regional therapy.
  • Local-regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, transarterial chemoembolization [TACE], hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) completed at least 4 weeks prior to the baseline imaging scan (2 weeks for palliative radiotherapy), and all toxicities induced by local-regional therapy (excluding alopecia) must have recovered to ≤ Grade 1 per the National Cancer Institute , version 5.0 (NCI-CTCAE v5.0).
  • Documented disease progression or intolerance after at least one prior standard immunotherapy and/or targeted therapy for HCC.
  • At least one per v1.1 (the measurable lesion must have a longest diameter ≥ 10 mm on spiral CT scan, or a short-axis diameter ≥ 15 mm on CT scan for lymph node lesions; lesions previously treated with local-regional therapy may be selected as target lesions if clearly progressive per RECIST v1.1).
  • liver function class A, or good class B (score ≤ 7).
  • (ECOG) performance status 0-1.
  • ≥ 12 weeks.
  • Adequate major organ function, meeting all of the following requirements (assessed within 7 days prior to initiation of study treatment):
  • Hematology: (ANC) ≥ 1.5 × 10\^9/L; count (PLT) ≥ 75 × 10\^9/L; ≥ 90 g/L;
  • Serum biochemistry: albumin ≥ 25 g/L; total ≤ 3.0 × (ULN); (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 5 × ULN; creatinine (Cr) ≤ 1.5 × ULN or (CrCl) > 50 mL/min calculated by the Cockcroft-Gault formula: Male: CrCl = ((140 - age) × weight) / (72 × serum Cr); Female: CrCl = ((140 - age) × weight) / (72 × serum Cr) × 0.85 (weight in kg; serum Cr in mg/mL);
  • (INR) ≤ 2.3, or prothrombin time (PT) prolonged by ≤ 6 seconds above the normal control;
  • Urine protein \< 2+ (if urine protein ≥ 2+, 24-hour urine protein quantification may be performed; patients with 24-hour urine protein \< 1.0 g are eligible).
  • Patients with active virus (HBV) infection must receive anti-HBV therapy prior to initiation of study treatment and be willing to continue antiviral therapy throughout the entire study period; patients positive for virus (HCV) ribonucleic acid (RNA) must receive antiviral therapy according to local standard treatment guidelines, with liver function test elevations within CTCAE Grade 1.
  • Women of must have a negative serum or urine pregnancy test within 7 days prior to study enrollment, must not be breastfeeding, and must agree to use during the study period and for 6 months after the end of the study; male patients must agree to use contraception during the study period and for 6 months after the end of the study.

Exclusion criteria

Exclusion Criteria:

  • Known cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma (combined hepatocellular-cholangiocarcinoma), or fibrolamellar carcinoma; other active (ies) other than HCC within the past 5 years or concurrently. Patients with adequately treated localized tumors, such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast, are eligible.
  • Patients who are planning to undergo, or have previously undergone, organ or bone marrow transplantation.
  • Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage; uncontrolled pleural effusion or pericardial effusion of moderate volume or greater.
  • History of gastrointestinal (GI) bleeding within 6 months prior to initiation of study treatment, or a definite tendency toward GI bleeding, such as: esophageal or gastric fundal varices at risk of bleeding or with severe varices, locally active GI ulcerative lesions, or persistently positive fecal occult blood; such patients are not eligible.
  • Abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment.
  • Known hereditary or acquired hemorrhagic tendency (e.g., coagulation dysfunction) or thrombotic tendency.
  • Currently receiving, or recently received (within 10 days prior to initiation of study treatment), aspirin > 325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, or cilostazol.
  • Thrombotic or embolic events within 6 months prior to initiation of study treatment, such as cerebrovascular accidents (including , cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
  • Uncontrolled cardiac symptoms or diseases, such as: (1) heart failure of (NYHA) Class II or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) supraventricular or ventricular arrhythmia requiring clinical intervention; (5) hypertension inadequately controlled by medication, with a high risk of apatinib treatment as assessed by the investigator.
  • Prior hypertensive crisis or hypertensive encephalopathy.
  • Major vascular disease within 6 months prior to initiation of study treatment (e.g., aortic aneurysm requiring surgical repair, or recent peripheral arterial thrombosis).
  • Severe, unhealed, or dehiscent wounds, active ulcers, or untreated bone fractures.
  • Major surgery (excluding diagnostic procedures) within 4 weeks prior to initiation of study treatment, or anticipated major surgery during the study period.
  • Inability to swallow tablets, malabsorption syndrome, or any condition affecting GI absorption.
  • Intestinal obstruction within 6 months prior to initiation of study treatment, and/or clinical signs or symptoms of GI obstruction.
  • Evidence of intra-abdominal free air that cannot be explained by paracentesis or recent surgical procedures.
  • Prior or current central nervous system (CNS) .
  • History of hepatic encephalopathy.
  • Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring therapy; or other pulmonary conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonitis, or severely impaired pulmonary function; active tuberculosis.
  • Active disease or a history of autoimmune disease with a risk of recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [patients whose condition can be controlled by hormone replacement therapy alone are eligible]); patients with asthma requiring bronchodilator medical intervention are not eligible.
  • Use of agents or systemic corticosteroids for the purpose of immunosuppression (prednisone > 10 mg/day or equivalent doses of other corticosteroids) within 14 days prior to initiation of study treatment.
  • Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; oral or intravenous therapeutic antibiotics within 2 weeks prior to initiation of study treatment (patients receiving prophylactic antibiotics, e.g., for prevention of urinary tract infection or exacerbation, are eligible).
  • Congenital or acquired immunodeficiency (e.g., patients with infection).
  • Receipt of within 28 days prior to initiation of study treatment, or anticipated need for such vaccination during camrelizumab treatment or within 60 days after the last dose of camrelizumab.
  • Receipt of other drugs within 28 days prior to initiation of study treatment.
  • In the judgment of the investigator, any other factors that may affect the study results or lead to premature termination of the study, such as alcohol abuse or drug abuse, other serious illnesses (including psychiatric disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that may compromise patient safety.
Terms in these criteria, in plain language(34)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    Experimental: QL1706 Plus Lenvatinib and FOLFOX Chemotherapy

    Participants receive QL1706 (iparomlimab and tuvonralimab, a PD-1/CTLA-4 antibody combination) 5 mg/kg IV over 30 minutes on Day 1 of each 21-day cycle; lenvatinib 8 mg/day (body weight \<60 kg) or 12 mg/day (≥60 kg) orally once daily; and FOLFOX every 3 weeks for up to 6 cycles: oxaliplatin 85 mg/m2 IV over 2 h, levoleucovorin calcium 200 mg/m2 IV, fluorouracil 400 mg/m2 IV bolus then 2400 mg/m2 IV infusion over 46 h, all on Day 1. When QL1706 and FOLFOX coincide, QL1706 is given first. QL1706 and lenvatinib continue until RECIST v1.1-confirmed progression, unacceptable toxicity, withdrawal of consent, or 2 years, whichever occurs first. For surgical conversion, lenvatinib is stopped 1 week before surgery; postoperative treatment follows pathological response.

    Drug: Intervention 1 - Drug QL1706 (Iparomlimab and Tuvonralimab) Intervention 2 - Drug Lenvatinib Intervention 3 - Drug FOLFOX Chemotherapy (Oxaliplatin, Fluorouracil, and Levoleucovorin Calcium)

Interventions

  • DrugIntervention 1 - Drug QL1706 (Iparomlimab and Tuvonralimab) Intervention 2 - Drug Lenvatinib Intervention 3 - Drug FOLFOX Chemotherapy (Oxaliplatin, Fluorouracil, and Levoleucovorin Calcium)

    QL1706 (Iparomlimab and Tuvonralimab):5 mg/kg IV over 30 min on Day 1 Q3W until progression or 2 years.Lenvatinib :8 mg/day if \<60 kg, 12 mg/day if \>=60 kg; orally once daily.FOLFOX Chemotherapy:Oxaliplatin 85 mg/m2 + leucovorin + 5-FU IV Day 1 Q3W, max 6 cycles.

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) per RECIST v1.1

    From first dose of study treatment until documented disease progression, death, or up to 2 years, whichever occurs first.

    Time frame: From first dose of study treatment to Week 104.

Secondary outcomes

  1. Progression-Free Survival (PFS) per RECIST v1.1

    PFS is defined as the time from first dose of study treatment to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first, assessed by the investigator.

    Time frame: From first dose of study treatment to Week 104

  2. Overall Survival (OS)

    OS is defined as the time from first dose of study treatment to death from any cause. Participants without documented death at the cutoff are censored at the date of last contact.

    Time frame: From first dose of study treatment to Week 104

Other outcomes

  1. Disease Control Rate (DCR) per RECIST v1.1

    DCR is defined as the proportion of participants achieving confirmed complete response (CR), partial response (PR), or stable disease (SD) maintained for at least 6 weeks, as assessed by the investigator per RECIST v1.1.

    Time frame: From first dose of study treatment to Week 24

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — The sponsor has no plan to share individual participant data (IPD). IPD will not be shared because the informed consent did not include authorization for public data sharing, and sharing could compromise participant privacy and confidentiality. De-identified, aggregate study results will be published in peer-reviewed journals and posted in public trial registries.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.

Of 348 non-industry phase 2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 78. This study's planned 36 months is below that.

Counting every sponsor, half of 428 studies reached it within 43 months; a quarter within 30 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Nov 12, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 1, 2029
CompletionEst.
Dec 1, 2030
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933016
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2029 (estimated)
Completion
Dec 1, 2030 (estimated)
Last update
Nov 12, 2026

Study contacts

Linhui Peng, MD
Contact
515332927@qq.com
+8613710591214 ext. +8619925780179
Xiao Hu, MS
Contact
19925780179@163.com
+8619925780179

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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