A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCC
NCT ID: NCT05839197
Last Updated: 2023-12-19
Study Results
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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RECRUITING
PHASE2
38 participants
INTERVENTIONAL
2023-05-05
2025-04-15
Brief Summary
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Detailed Description
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Study population:
38 untreated patients with unresectable middle-advanced macrotrabecular-massive hepatocellular carcinoma
Treatment:
All patients were treated with standard HAIC (administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries) on the first day (D1).
Immediately after the first HAIC, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1).
Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC.
The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study.
Curative effect evaluation： The tumor condition was evaluated by imaging method at D28 (±7 days) after each HAIC, until the curative effect was evaluated as PD or unsuitable for further treatment. After 3 times of HAIC treatment, the tumor efficacy was evaluated every 8 weeks (±3 days) after the first HAIC treatment until disease progression (Response Evaluation Criteria In Solid Tumors（RECIST）1.1) or death (during treatment) or toxicity intolerable. The tumor treatment and survival status after disease progression were recorded.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HAIC Combined With Apatinib and Camrelizumab
All patients were treated with standard HAIC on the first day (D1). Immediately after the first HAIC, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1).
Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC.
The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study.
HAIC
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.
Camrelizumab plus Apatinib
Apatinib(250 mg; p.o.; qd.); camrelizumab (200 mg; iv drip; q3w) If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1).
Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC.
Interventions
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HAIC
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.
Camrelizumab plus Apatinib
Apatinib(250 mg; p.o.; qd.); camrelizumab (200 mg; iv drip; q3w) If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1).
Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage Ⅰa\~Ⅱb and up-to-seven（tumor number +tumor size≥7) OR stage Ⅲa according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022 Edition);
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; expected survival ≥ 12 weeks;
* Child-Pugh liver function class A-B7
* Patients with newly diagnosed hepatocellular carcinoma who have not received any local or systemic treatment for hepatocellular carcinoma;
* At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cm was accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and the target lesion had not received local treatment in the past (including not limited to hepatic arterial Infusion chemotherapy, radiofrequency ablation, argon-helium knife, radiotherapy, etc.);
* No serious organic diseases of heart, lung, brain and other organs;
Exclusion Criteria
* Participated in clinical trials of other antineoplastic drugs within 4 weeks before entering the group.
* Received any surgery or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before the start of the group;
* History of previous immune and targeted therapy for HCC;
* Patients who have previously received organ transplants or planned organ transplants;
* Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry.
* Active or uncontrolled severe infection (≥ （Common Terminology Criteria for Adverse Events）CTCAE 2 grade infection);
* Suffered from other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ;
* Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the researchers, there is reason to suspect that the patient has a disease or state that is not suitable for the use of research drugs (such as having seizures and requiring treatment), or will affect the interpretation of the results of the study, or put the patient at high risk;
* The researchers judged that patients have other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, and other serious diseases (including mental illness) that need to be combined with treatment. there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients.
18 Years
75 Years
ALL
No
Sponsors
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Wan-Guang Zhang
OTHER
Responsible Party
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Wan-Guang Zhang
Professor
Principal Investigators
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Wanguang Zhang, M.D.,Ph.D. Wanguang Zhang, M.D.,Ph.D., M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Medical Ethics Committee of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Locations
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Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Wan-guang Zhang, M.D.
Role: primary
Other Identifiers
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TJ-IRB202303126
Identifier Type: -
Identifier Source: org_study_id