A Neoadjuvant Hepatocellular Carcinoma Study of Camrelizumab in Combination With Apatinib and Oxa… (NCT04850040) | Clinical Trial Compass
UnknownPhase 2
A Neoadjuvant Hepatocellular Carcinoma Study of Camrelizumab in Combination With Apatinib and Oxaliplatin
15 participantsStarted 2021-05-06
Plain-language summary
This is a prospective, single-arm, single-center, clinical research.This trial will explore the efficacy and safety of Camrelizumab in combination with Apatinib Mesylate and Oxaliplatin for neoadjuvant therapy in patients with potentially resectable hepatocellular carcinoma.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18-70 years old, both genders.
. ECOG PS 0-1 points.
. Hepatocellular liver cancer with a clinical diagnosis consistent with primary hepatocellular liver cancer and a lesion consistent with the Primary Liver Cancer Diagnostic and Treatment Standards (2019) Edition.
. The hepatobiliary MDT of Cancer Hospital of Chinese Academy of Medical Sciences (MDT) discussed the case as potentially resectable requiring neoadjuvant chemotherapy.
. Locally advanced, potentially resectable tumors. Ruptured liver tumor or adjacent organ invasion without extrahepatic metastasis (imaging confirmed).
. CMP ALB ≥30g/L； ALT and AST\< 2.5ULN； TBIL ≤1.5 ULN； Cr ≤1.5ULN 12. Women of childbearing age (18-49 years covered by this protocol) must have a negative pregnancy test (serum or urine) result within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug; for men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last dose of study drug.
Exclusion criteria
. History of other malignancies within the previous 5 years or concurrently, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and papillary thyroid cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Pathological Response(MPR) 10%
Timeframe: Up to two years
Trial details
NCT IDNCT04850040
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. History of ruptured esophagogastric fundic varices, hepatic encephalopathy, massive ascites, and abdominal infection
. Patients with previous use of other anti-angiogenic drugs, immunotherapeutic drugs, radiotherapy or systemic chemotherapy
. Prior use of immunosuppressive drugs, excluding nasal spray and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg days of prednisolone or equivalent pharmacologic doses of other corticosteroids), within 14 days prior to the first administration of kareolizumab
. Known hypersensitivity to apatinib, carrilizumab, oxaliplatin, or drug excipients; or severe allergic reactions to other monoclonal antibodies
. Live attenuated vaccines administered within 4 weeks prior to the first dose or scheduled to be administered during the study.
. Known uncontrolled or symptomatic active central nervous system (CNS) metastases as evidenced by the presence of clinical signs, cerebral edema, spinal cord compression, carcinomatous meningitis, soft meningeal disease, and or progressive growth. Patients with a history of CNS metastases or spinal cord compression who are clearly treated and clinically stable after discontinuation of anticonvulsants and steroids for 4 weeks prior to the first dose of the study may be enrolled in the study.
. The presence of \> grade 1 peripheral neuropathy