Can a Four-Drug combo tackle a tough liver cancer?
NCT ID NCT07776080
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether combining two immunotherapy drugs (iparomlimab and tuvonralimab) with lenvatinib, radiotherapy, and chemotherapy delivered directly to the liver can help people with hepatocellular carcinoma that has spread into the portal vein. The study aims to see how long the cancer stays under control, whether tumors shrink, and if the treatment can make surgery possible. It will also look for markers in blood and tissue that might predict who benefits most.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of iparomlimab and tuvonralimab (QL1706), lenvatinib, radiotherapy, and hepatic arterial infusion chemotherapy (HAIC)
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for a difficult-to-treat liver cancer, potentially shrinking tumors enough to allow surgery and improve survival.
- What could go wrong
- This is an early-phase, small study (35 participants). The combination may cause significant side effects, and results may not confirm benefit or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 and ≤75 years at the time of signing informed consent. 2. Histologically or clinically confirmed hepatocellular carcinoma (HCC) according to the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer. 3. Radiologically confirmed portal vein tumor thrombus (PVTT), classified as Cheng type I-IV. 4. No prior systemic or local treatment directed at PVTT, including targeted therapy, immunotherapy, or systemic chemotherapy. 5. Child-Pugh class A or B with a Child-Pugh score ≤7. 6. Considered unsuitable for curative surgery or liver transplantation after multidisciplinary evaluation, but suitable for radiotherapy. 7. Adequate organ function, including: WBC ≥3.0 × 10⁹/L; PLT ≥50 × 10⁹/L; hemoglobin ≥80 g/L; ALT ≤5 × ULN; AST ≤5 × ULN; total bilirubin ≤3 × ULN; albumin ≥28 g/L; and creatinine clearance ≥80 mL/min. 8. At least one measurable lesion according to mRECIST. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 10. Life expectancy \>3 months. 11. No history of abdominal radiotherapy. 12. Women of childbearing potential must use effective contraception beginning at least 1 month before screening and throughout the study until the protocol-specified period after study completion. 13. Willing and able to comply with study follow-up until death, study completion, or study termination. Exclusion Criteria: 1. ECOG performance status ≥2. 2. Child-Pugh score ≥8. 3. Severe dysfunction of major organs, including the heart, liver, or kidneys. 4. Prior targeted therapy, immunotherapy, radiotherapy, systemic chemotherapy, or other anticancer treatment. 5. Known hypersensitivity or allergic reaction to any component of the study treatment. 6. History of organ transplantation or autologous/allogeneic stem cell transplantation. 7. Currently receiving chronic systemic immunotherapy or hormonal therapy other than physiologic replacement therapy. 8. Any unstable systemic disease, including active infection; uncontrolled severe hypertension; unstable angina; new-onset angina within the previous 3 months; congestive heart failure of NYHA class II or higher; myocardial infarction within the previous 6 months; severe cardiac arrhythmia requiring medication; gastrointestinal bleeding within the previous 1 month; or active bleeding tendency. 9. Concurrent other malignancy that has not been cured, except carcinoma in situ at another site. 10. Any disease, metabolic disorder, physical examination finding, or laboratory abnormality that, in the investigator's judgment, suggests a contraindication to the study treatment or a high risk of treatment-related complications. 11. Evidence of acute or active hepatitis B or hepatitis C infection, including HBV-DNA \>2,000 IU/mL or HCV-RNA \>1,000 copies/mL. 12. Pregnancy or breastfeeding. 13. Any other unfavorable medical or psychiatric condition that, in the investigator's judgment, may affect protocol compliance or evaluation of study endpoints and makes the participant unsuitable for the study. 14. Lack of legal capacity or limited legal capacity. 15. Other contraindications to radiotherapy or targeted/immunotherapy. 16. Any participant considered unsuitable for enrollment by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Wuhan, Hubei, 430022, China
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