Last updated: December 13, 2023
Sponsor: Wan-Guang Zhang
Overall Status: Active - Recruiting
Phase
2
Condition
Carcinoma
Treatment
Camrelizumab plus Apatinib
HAIC
Clinical Study ID
NCT05839197
TJ-IRB202303126
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Macrotrabecular Massive HCC diagnosed by histopathology or cytology according to theGuidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022Edition);
- Stage Ⅰa~Ⅱb and up-to-seven(tumor number +tumor size≥7) OR stage Ⅲa according to theGuidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022Edition);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; expectedsurvival ≥ 12 weeks;
- Child-Pugh liver function class A-B7
- Patients with newly diagnosed hepatocellular carcinoma who have not received any localor systemic treatment for hepatocellular carcinoma;
- At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cmwas accurately measured by magnetic resonance imaging (MRI) enhancement or computedtomography (CT) enhancement, and the target lesion had not received local treatment inthe 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
Exclusion Criteria:
- Women who are pregnant (positive for pre-medication pregnancy test) or breastfeeding
- Participated in clinical trials of other antineoplastic drugs within 4 weeks beforeentering the group.
- Received any surgery or invasive treatment or operation (except venouscatheterization, puncture and drainage, etc.) within 4 weeks before the start of thegroup;
- 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 wasidentified by the investigator during the 30 days prior to study entry.
- Active or uncontrolled severe infection (≥ (Common Terminology Criteria for AdverseEvents)CTCAE 2 grade infection);
- Suffered from other malignant tumors in the past 5 years, except basal cell orsquamous cell carcinoma of the skin after radical resection, or cervical carcinoma insitu;
- Any other disease, with clinically significant metabolic abnormalities, physicalexamination abnormalities or laboratory abnormalities, according to the researchers,there is reason to suspect that the patient has a disease or state that is notsuitable for the use of research drugs (such as having seizures and requiringtreatment), or will affect the interpretation of the results of the study, or put thepatient at high risk;
- The researchers judged that patients have other factors that may affect the results ofthe 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 withtreatment. there are serious laboratory abnormalities, accompanied by family or socialfactors, which will affect the safety of patients.
Study Design
Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Camrelizumab plus Apatinib
Phase: 2
Study Start date:
May 05, 2023
Estimated Completion Date:
April 15, 2025
Study Description
Connect with a study center
Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaActive - Recruiting

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