HAIC Combined With Second-line "Target Immunity" for HCC With TACE Standard Treatment Low Response or Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-02-01

Brief Summary

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This study is a prospective, randomized controlled, multicenter clinical study. The purpose of this study is to explore the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with second-line regorafenib and immune checkpoint inhibitors in the treatment of transarterial chemoembolization (TACE) combined with first-line molecular targeted drugs and immune checkpoint inhibitors with low response or failure in advanced hepatocellular carcinoma.

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Detailed Description

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This is a randomized, open, parallel-controlled, multi-center clinical trial with a type of comparison using a merit test. This study will recruit 176 patients with advanced liver cancer who have received TACE combined with first-line "target immune" therapy and were rated as low response or treatment failure according to mRECIST criteria in multiple research centers across the country. Subjects randomly assigned to the experimental group will receive HAIC in combination with regorafenib and immune checkpoint inhibitors, and subjects randomly assigned to the control group will receive TACE in combination with regorafenib and immune checkpoint inhibitors.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HAIC combined with regorafenib and immune checkpoint inhibitors

Subjects received FOLFOX regimen HAIC treatment, within 2 weeks of regorafenib (28 days as a cycle, 80-160 mg qd regorafenib orally on days 1-21) and immune checkpoint inhibitors (continue treatment according to the original plan, 1 cycle every 3 weeks) treatment. HAIC treatment was repeated every 3 weeks for a maximum of six cycles.

Group Type EXPERIMENTAL

Hepatic Artery Infusion Chemotherapy

Intervention Type PROCEDURE

HAIC adopts FOLFOX chemotherapy regimen, hepatic arteriography through a radial artery or femoral artery cannulation, routine hepatic artery cannulation, imaging, infusion of chemotherapy drugs into hepatic artery: oxaliplatin 85 mg/m2 on the first day for 0-3 hours, folinic acid 400 mg/m2 for 3-4.5 hours on day 1, fluorouracil 400 mg/m2 for 4.5-6.5 hours on day 1, and fluorouracil 2500 mg/m2 for 46 hours on days 1-3.

Regorafenib

Intervention Type DRUG

Regorafenib is administered for 28 days per treatment cycle, with oral regorafenib on days 1-21, 80-160 mg once daily. The dose is adjusted according to adverse reactions, with a minimum of 80 mg.

Immune Checkpoint Inhibitors

Intervention Type DRUG

Optional immune checkpoint inhibitors include Camrelizumab, Sintilimab, Nivolumab, Pembrolizumab, and Toripalimab. Treatment is based on the immune checkpoint inhibitor before the patients are randomized into the group, and it is not recommended to replace the immune checkpoint inhibitor. The dosage is 200 mg, intravenous infusion, D1, once every 21 days (Q3W). Dosing interruption or dose reduction may be necessary based on individual safety and tolerability considerations; dosing with immune checkpoint inhibitors should not be suspended for more than 4 weeks.

TACE combined with regorafenib and immune checkpoint inhibitors

Choose traditional precise cTACE or dTACE treatment, and receive regorafenib within 2 weeks (28 days as a cycle, 80-160mg qd regorafenib orally on d1-21) and immune checkpoint inhibitors (continue treatment according to the original plan, every 3 weeks as a cycle) treatment. CT or MRI examination was repeated 4-6 weeks after the operation to evaluate whether there were active lesions. If there were still active lesions, one repeat TACE could be performed, and the number of TACE was less than 3 times.

Group Type ACTIVE_COMPARATOR

Transarterial Chemoembolization

Intervention Type PROCEDURE

Treatment regimens have chosen "lipiodol-based" hepatic arterial chemoembolization, with lipiodol dosage varying from 5-20ml depending on tumor size. The chemotherapy drug is gemcitabine 1.0 combined with 100mg oxaliplatin, combined with 1/3 to 1 dose of solid embolic agent (the dosage is determined by the investigator based on the tumor size). After uniform emulsification, the drug is injected into the supplying blood vessels and stops when the intravascular blood flow is slow. Later, angiography is performed again, and the tumor staining disappears and the supplying artery is occlusions.

CT or MRI scans are performed 4 to 6 weeks postoperatively to assess the presence of active lesions. Repeat TACE if active lesions are still present. The frequency of TACE treatment is determined by the investigator and is given according to the patient's condition, generally 2-4 times. The interval between TACE treatments is 30-45 days, with a maximum of six cycles.

Regorafenib

Intervention Type DRUG

Regorafenib is administered for 28 days per treatment cycle, with oral regorafenib on days 1-21, 80-160 mg once daily. The dose is adjusted according to adverse reactions, with a minimum of 80 mg.

Immune Checkpoint Inhibitors

Intervention Type DRUG

Optional immune checkpoint inhibitors include Camrelizumab, Sintilimab, Nivolumab, Pembrolizumab, and Toripalimab. Treatment is based on the immune checkpoint inhibitor before the patients are randomized into the group, and it is not recommended to replace the immune checkpoint inhibitor. The dosage is 200 mg, intravenous infusion, D1, once every 21 days (Q3W). Dosing interruption or dose reduction may be necessary based on individual safety and tolerability considerations; dosing with immune checkpoint inhibitors should not be suspended for more than 4 weeks.

Interventions

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Hepatic Artery Infusion Chemotherapy

HAIC adopts FOLFOX chemotherapy regimen, hepatic arteriography through a radial artery or femoral artery cannulation, routine hepatic artery cannulation, imaging, infusion of chemotherapy drugs into hepatic artery: oxaliplatin 85 mg/m2 on the first day for 0-3 hours, folinic acid 400 mg/m2 for 3-4.5 hours on day 1, fluorouracil 400 mg/m2 for 4.5-6.5 hours on day 1, and fluorouracil 2500 mg/m2 for 46 hours on days 1-3.

Intervention Type PROCEDURE

Transarterial Chemoembolization

Treatment regimens have chosen "lipiodol-based" hepatic arterial chemoembolization, with lipiodol dosage varying from 5-20ml depending on tumor size. The chemotherapy drug is gemcitabine 1.0 combined with 100mg oxaliplatin, combined with 1/3 to 1 dose of solid embolic agent (the dosage is determined by the investigator based on the tumor size). After uniform emulsification, the drug is injected into the supplying blood vessels and stops when the intravascular blood flow is slow. Later, angiography is performed again, and the tumor staining disappears and the supplying artery is occlusions.

CT or MRI scans are performed 4 to 6 weeks postoperatively to assess the presence of active lesions. Repeat TACE if active lesions are still present. The frequency of TACE treatment is determined by the investigator and is given according to the patient's condition, generally 2-4 times. The interval between TACE treatments is 30-45 days, with a maximum of six cycles.

Intervention Type PROCEDURE

Regorafenib

Regorafenib is administered for 28 days per treatment cycle, with oral regorafenib on days 1-21, 80-160 mg once daily. The dose is adjusted according to adverse reactions, with a minimum of 80 mg.

Intervention Type DRUG

Immune Checkpoint Inhibitors

Optional immune checkpoint inhibitors include Camrelizumab, Sintilimab, Nivolumab, Pembrolizumab, and Toripalimab. Treatment is based on the immune checkpoint inhibitor before the patients are randomized into the group, and it is not recommended to replace the immune checkpoint inhibitor. The dosage is 200 mg, intravenous infusion, D1, once every 21 days (Q3W). Dosing interruption or dose reduction may be necessary based on individual safety and tolerability considerations; dosing with immune checkpoint inhibitors should not be suspended for more than 4 weeks.

Intervention Type DRUG

Other Intervention Names

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HAIC TACE second-line target drug Camrelizumab, Sintilimab, Nivolumab, Pembrolizumab, Toripalimab

Eligibility Criteria

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Inclusion Criteria

* Voluntarily participate in this study and sign the informed consent;
* Age ≥18 years old to 70 years old;
* Patients diagnosed with primary liver cancer by histopathology, cytology or imaging;
* The China liver cancer staging is IIb-IIIa;
* Patients with intermediate and advanced liver cancer who must receive at least one cycle of TACE combined with first-line "target immune" therapy and are assessed as partial remission (PR), stable disease (SD）(low response), and progressive disease (PD) (failure) according to mRECIST criteria;
* At least one measurable (based on RECIST 1.1 criteria and mRECIST criteria) lesions, tumor lesions located at the local treatment site, if progressed, considered measurable;
* Local treatment (surgery, radiotherapy, radiofrequency/microwave ablation, cryoablation, percutaneous ethanol injection) can be used in the past, but it must be completed before 3 months;
* ECOG PS score ≤ 2;
* Child-Pugh liver function classification: grade A/B (≤9 points);
* Expected survival \> 3 months;
* Patients with active hepatitis B virus (HBV) infection: HBV DNA ≤2000 IU/mL (104 cps/ml) obtained within 28 days prior to initiation of study treatment, and receiving anti-HBV treatment for at least 14 days prior to study entry (based on local standard treatment) and willing to continue to receive treatment during the study;

Exclusion Criteria

* Have received HAIC treatment in the past;
* Known allergy to possible therapeutic drugs;
* Previously received regorafenib treatment;
* According to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0), the toxicity grade caused by TACE combined with first-line "target immunity" treatment is \> grade 3;
* Patients with liver decompensation, including esophageal or gastric variceal bleeding or hepatic encephalopathy, pregnancy or breastfeeding and other aggressive malignant diseases;
* Use immunosuppressive drugs and high-dose hormone therapy within 2 weeks before randomization to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other hormones with equivalent efficacy);
* CART treatment within 3 months before randomization;
* Laboratory test values 1 week before randomization: blood routine: ① leukocyte \<3.0×109/L; ② absolute neutrophil count \<1.5×109/L; ③ platelets \<75×109/L; ④ hemoglobin \< 90g/L; liver function: ①serum albumin\<30g/L; ②ALT and AST\>5×ULN; renal function: ①serum creatinine\>1.5×ULN; ②Cr clearance rate\<50ml/min; ③estimated renal small Globular filtration rate (eGFR) \<30 mL/min/1.73 m2; coagulation function: ① international normalized ratio (INR)\> 2; ② prothrombin time (PT) exceeding the range of normal control\> 6 seconds;
* Uncontrolled hypertension (systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 110 mmHg);
* Uncontrollable diabetes;
* Active heart disease, including myocardial infarction, unstable angina pectoris, NYHA class II and above heart failure, and poorly controlled arrhythmias (including QTcF interval \>450 ms in men and \>470 ms in women);
* Women are pregnant or breastfeeding;
* History of any active autoimmune disease or autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, vasculitis, glomerulonephritis, hyperthyroidism, or hypothyroidism, asthma requiring bronchodilator treatment, etc;
* Uncontrolled clinically significant ascites (uncontrolled with diuretics or paracentesis);
* Combined with active infection, except HBV and HCV;
* Arterial or venous thrombosis or embolic events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis or pulmonary embolism, occurred 6 months before starting drug treatment;
* Known central nervous system (CNS) metastasis or meningeal metastasis;
* The patient cannot receive follow-up or is participating in other clinical trials;
* The investigator believes that the patient has other conditions that make it inappropriate to participate in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No