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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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This study used (cTACE or DEB-TACE + FOLFOX scheme HAIC) combined with PD-1 antibody camrelizumab and apatinib mesylas in the treatment of patients with advanced liver cancer, to evaluate the effectiveness and safety of the combined treatment for clinical liver cancer treatment.It will provide new evidence-based medical evidence.This study is a prospective, open, single center, exploratory clinical study and the sample size is 56.Main research purpose:To evaluate the effectiveness of cTACE or DEB-TACE + FOLFOX regimen HAIC combined with camrelizumab and apatinib mesylas in the treatment of advanced hepatocellular carcinoma.Secondary research purpose:To evaluate the safety of cTACE or DEB-TACE + FOLFOX regimen HAIC combined with camrelizumab and apatinib mesylas in the treatment of advanced hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the group of HAIC combined with carilizumab and apatinib mesylate treatment | Experimental | cTACE or DEBTACE+FOLFOX scheme HAIC, arterial chemotherapy scheme: OXA 65-85mg/m2 arterial H0-4 pump, calcium folinate 200mg/ m2 intravenous pump H2-4, 5-FU 1g-1.5g/ m2 arterial H4-24 pump, once every 6-8 weeks, the interventional treatment times are determined by researchers according to the patient's condition, and two times are adjacent. Apatinib mesylate tablets, 250mg/ time, once a day. Take it about half an hour after a meal (the daily medication time should be as same as possible), and take it with warm boiled water. Karelizumab, 200mg, was given intravenously for 30 minutes (including the flushing time, the whole infusion time was not shorter than 20 minutes and not longer than 60 minutes), and the medication period was q3w(±3 days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab for injection is used to treat patients with relapsed or refractory classic Hodgkin lymphoma who have undergone at least second-line chemotherapy. Approved by the Drug Administration (NMPA) on March 4, 2020, for the treatment of patients with advanced hepatocellular carcinoma who have previously received sorafenib therapy and/or oxaliplatin-containing chemotherapy.Apatinib Mesylas is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant tumors by inhibiting VEGFR to play an anti-angiogenic effect. It has been approved by the China Food and Drug Administration (CFDA) in November 2014. It is used as a monotherapy for advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma that has progressed or relapsed after receiving two kinds of systemic chemotherapy. Apatinib Mesylas can effectively inhibit VEGFR2 at very low concentrations, and higher concentrations can also inhibit PDGFR, c-Kit and c-Src and other kinases. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS refers to the length of time from the beginning of treatment to disease progression or death for any reason. | Up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The objective response rate (ORR) refers to the proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit. | Up to 2 years. |
| DCR |
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Inclusion Criteria:
(1) routine blood examination:
a)ALB ≥29g/L; B)ALT and ast < 3 uln; c)TBIL ≤1.5ULN; D) creatinine ≤ 1.5 uln; 8. Women of childbearing age (generally 15-49 years old) must have a negative pregnancy test (serum or urine) within 14 days before entering the group, and voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration of research drugs; For men, they should be sterilized by surgery or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of study drugs.
Exclusion Criteria:
(1) Active peptic ulcer lesions; (2) Those who have a history of black stool and hematemesis within 3 months; (3) For fecal occult blood (+) or (+/-), it needs to be reviewed within 1 week, and gastroscopy should be performed if it is still (+) or (+/-). If there is ulcer or hemorrhagic disease, and the attending doctor thinks there is potential bleeding risk; 15. Arterial/venous thrombosis events occurred within 6 months before entering the study, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism, etc.; 16. Infections requiring drug intervention within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown cause > 38.5°C; during screening/before the first administration; 17. Participated in any other drug clinical research within 4 weeks before the first administration; 18. It is known that there is a history of psychotropic drug abuse or drug abuse; There are other serious physical or mental diseases or abnormal laboratory examination, which may increase the risk of participating in the study, or interfere with the results of the study, and the researchers think that the patients are not suitable for participating in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Zhu, MD | Contact | +86-10-88196476 | drzhuxu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xu Zhu, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Xiaodong Wang, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
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Disease control rate (DCR) refers to the proportion of patients whose tumors shrink or stabilize and remain for a certain period of time, including cases with complete response (CR), partial response (PR), and stable (SD).
| Up to 2 years. |
| OS | Overall survival (OS) refers to the time from enrollment to death due to any cause. | Up to 2 years. |
| Incidence of AE and SAE | All adverse events in all subjects in the study. | Up to 2 years. |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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