A Phase 2 interventional study of Iparomlimab and Tuvonralimab (QL1706) and Lenvatinib in HCC - Hepatocellular Carcinoma, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 2, Interventional, and Treatment
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Among 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular — 13 open to participants now, 13 under way, 1 of them phase 3. Iparomlimab/Tuvonralimab · Carcinoma, Hepatocellular.
Among the 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular, this one is the 7th largest by planned enrollment, is one of 3 that started in 2026, is one of 7 in phase 2, reaches primary completion later than 7 of the 12 other live ones, and was the 12th registered.
3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.
Browse Carcinoma, Hepatocellular studies →13 of the 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular are open now, in 1 country. Recruiting first, the newest first:
Fudan University · Sites in China
Ages 18–75
Tongji Hospital · Sites in China
Ages 18–75
Nanjing Tianyinshan Hospital · Sites in China
Ages 18+
Hebei Medical University Fourth Hospital · Sites in China
Ages 18+
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
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 →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 8 · Phase 3 1 · Phase 4 1
First in 2023; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 35 is below the median of 54 across 2,619 interventional studies indexed under Carcinoma, Hepatocellular.
Median enrollment 35 across the 13 interventional studies. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
1 of 13 have an industry lead sponsor. The 10 most frequent:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 182 studies on the registry; 145 are open to participants now.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology has 4 studies filed under Carcinoma, Hepatocellular — fewer than ten, so there is no comparison to draw.
4 of the studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05976568Phase 3Qilu Pharmaceutical Co., Ltd.A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma | 2027-09-01 |
| NCT07115550Huai'an First People's HospitalA Single-center, Single-arm, Phase II Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With Regorafenib in the Treatment of Advanced Second-line or Above Hepatocellular Carcinoma | 2027-08-26 |
| NCT06884982Northern Jiangsu People's HospitalAn Exploratory Clinical Study on Neoadjuvant Treatment of Hepatocellular Carcinoma with QL1706 Combined with Lenvatinib | 2027-09-30 |
| NCT07776080Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyIparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus | 2027-10-01 |
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Among the 13 studies testing Iparomlimab/Tuvonralimab in Carcinoma, Hepatocellular, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to learn how well a combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) works and how safe it is for people with hepatocellular carcinoma (HCC) that has grown into the portal vein, forming a portal vein tumor thrombus (PVTT).
Participants will receive iparomlimab and tuvonralimab together with lenvatinib, radiotherapy directed at the portal vein tumor thrombus, and HAIC, which delivers chemotherapy directly through the hepatic artery. Researchers will evaluate how long the cancer remains controlled without getting worse, how much the tumors shrink, how long participants survive, and whether the treatment makes surgery possible for some participants. Treatment-related side effects will also be assessed.
The study will also explore whether features in tumor tissue and blood are associated with treatment response and may help identify patients who are more likely to benefit from this treatment strategy.
This is a prospective, single-center, single-arm Phase II study designed to evaluate the efficacy and safety of a multimodal first-line treatment strategy consisting of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT). A total of 35 participants are planned to be enrolled.
Treatment will be administered according to the following sequence. Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at a dose of 7.5 mg/kg on Day 1 of each 3-week cycle, with each infusion given over 30-60 minutes. Lenvatinib will be administered orally once daily at 8 mg for participants weighing \<60 kg and 12 mg for those weighing ≥60 kg.
PVTT-directed external beam radiotherapy will be initiated within 7 days after the first administration of QL1706. The radiation target will include the PVTT. Gross tumor volume will be delineated based on the venous or delayed phase of contrast-enhanced imaging. A planning target volume margin of approximately 5-15 mm will be added according to the protocol. Stereotactic body radiotherapy will be delivered at a total dose of 18-40 Gy, with a dose of 3-6 Gy per fraction.
HAIC will be initiated in combination with the second cycle of QL1706. Lenvatinib will be withheld for 3 days before HAIC and for 7 days after HAIC. The interruption period may be extended at the investigator's discretion according to the participant's clinical condition and laboratory findings. HAIC will be performed using a FOLFOX-based regimen through a catheter selectively placed in the main tumor-feeding hepatic artery. Oxaliplatin will be administered at 85 mg/m² by hepatic arterial infusion over 3 hours, followed by leucovorin calcium at 200 mg/m² over 3-5 hours. Fluorouracil will then be administered at 400 mg/m² by hepatic arterial injection, followed by 2400 mg/m² as a continuous hepatic arterial infusion over 46 hours. HAIC will be repeated every 3 weeks for up to 4 cycles, with the number of cycles adjusted according to the participant's clinical condition.
QL1706 and lenvatinib will be continued for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for treatment discontinuation. Tumor response will be assessed every 2 treatment cycles, corresponding to approximately every 6 weeks, according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Participants who achieve sufficient tumor regression will be reviewed by a multidisciplinary team, and those considered suitable for curative resection may undergo conversion surgery.
The primary objective of the study is to evaluate progression-free survival. Secondary assessments include objective response rate, disease control rate, duration of response, overall survival, conversion-to-surgery rate, pathological complete response in participants undergoing surgery, and treatment safety.
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.
Exclusion Criteria:
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
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.
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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 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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
iRECIST and mRECIST
Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive iparomlimab and tuvonralimab (QL1706) at 7.5 mg/kg intravenously on Day 1 every 3 weeks, together with oral lenvatinib once daily (8 mg for body weight \<60 kg and 12 mg for body weight ≥60 kg). PVTT-directed radiotherapy will be initiated within 7 days after the first QL1706 administration. HAIC with a FOLFOX regimen will be added from Cycle 2 and repeated every 3 weeks for up to 4 cycles. Lenvatinib will be withheld for 3 days before and 7 days after each HAIC procedure. QL1706 and lenvatinib will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation.
Drug: Iparomlimab and Tuvonralimab (QL1706) · Drug: Lenvatinib · Radiation: Radiotherapy · Procedure: hepatic arterial infusion chemotherapy (HAIC)
Drug page: Iparomlimab/Tuvonralimab
Iparomlimab and tuvonralimab (QL1706) will be administered intravenously at 7.5 mg/kg on Day 1 of each 3-week cycle. Each infusion will be administered over 30-60 minutes. Treatment will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation.
Lenvatinib will be administered orally once daily at 8 mg for participants weighing \<60 kg and 12 mg for participants weighing ≥60 kg. During HAIC treatment, lenvatinib will be withheld for 3 days before HAIC and for 7 days after HAIC. The interruption period may be extended at the investigator's discretion based on the participant's clinical condition and laboratory findings. Lenvatinib will continue for up to 2 years or until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation.
External beam radiotherapy directed at the portal vein tumor thrombus (PVTT) will be initiated within 7 days after the first administration of QL1706. The radiation target will include the PVTT. Gross tumor volume will be delineated based on the venous or delayed phase of contrast-enhanced imaging, and a planning target volume margin of approximately 5-15 mm will be applied according to the protocol. SBRT will be delivered at a total dose of 18-40 Gy with 3-6 Gy per fraction.
HAIC will be initiated during Cycle 2 of systemic therapy. Using a modified Seldinger technique, a catheter will be selectively placed in the main tumor-feeding hepatic artery for administration of FOLFOX chemotherapy. HAIC will be repeated every 3 weeks for up to 4 cycles, with the number of cycles adjusted according to the participant's clinical condition
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the first administration of study treatment to the first documented radiographic disease progression, as assessed by the investigator according to mRECIST, or death from any cause, whichever occurs first.
Time frame: From first administration of study treatment to radiographic disease progression or death from any cause, whichever occurs first, up to 24 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), as assessed by the investigator according to mRECIST.
Time frame: From first administration of study treatment to disease progression or the last tumor assessment, up to 24 months
Overall Survival (OS)
Overall survival is defined as the time from the first administration of study treatment to death from any cause.
Time frame: From first administration of study treatment to death from any cause, up to 24 months
Incidence and Severity of Adverse Events
The incidence and severity of adverse events will be assessed and graded according to NCI CTCAE version 5.0.
Time frame: From informed consent through 30 days after the last administration of study treatment
Plan to share: No — Individual participant data will not be shared to protect participant privacy and confidentiality.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 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 12 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Iparomlimab/Tuvonralimab · Lenvatinib
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →