Iparomlimab and Tuvonralimab With Lenvatinib, Radiotherapy, and HAIC for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

Condition(s) studied

Investigational drug(s) / intervention(s)

Iparomlimab and Tuvonralimab (QL1706): 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: 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.

Radiotherapy: 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.

hepatic arterial infusion chemotherapy (HAIC): 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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Progression-Free Survival (PFS) — From first administration of study treatment to radiographic disease progression or death from any cause, whichever occurs first, up to 24 months
  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.

Trial sites (1)

On this site

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

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