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This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with sintilimab and bevacizumab in the first line treatment of patients with BCLC-C hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC + Sintilimab + Bevacizumab | Experimental | HAIC combine with Sintilimab and bevacizumab biosimilar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAIC | Drug | Oxaliplatin: 85mg/m2 , Day 1 Leucovorin: 200mg/m2, Day 1 Fluorouracil: 400mg/m2, Day1 and 2400mg/m2 continuous arterial perfusion for 46h. Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) per RECIST v1.1 | Defined as a duration from the date of initial treatment to disease progression or death of any cause | From baseline to primary completion date, about 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| The treatment-related adverse events (TRAEs) | Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 | From baseline to primary completion date, about 18 months |
| Overall response rate (ORR) per RECIST v1.1 and mRECIST |
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Inclusion Criteria:
1. Written informed consent should be signed before implementing any trial-related procedures 2. ECOG PS scores 0-1 3. Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by American Association for the Study of Liver Diseases (AASLD) 4. Barcelona Clinic Liver Cancer (BCLC) stage C 5. Newly diagnosed HHC patients without any previous treatment for the tumor 6. Child Pugh score of ≤ 7. 7. Estimated survival > 12 weeks 8. At least one measurable lesion according to RECIST V1.1 9. Sufficient organ and bone marrow functions, with the laboratory test values within 7 days before the enrollment meeting the following requirements (no blood components, cell growth factors, albumin, and other drugs via intravenous or subcutaneous administrations are allowed for correction treatment within the first 14 days after the laboratory test results are obtained). The specific information is as follows:
10. Female patients of childbearing age or male patients with female sexual partners of childbearing age should take effective contraceptive measures throughout the treatment and 6 months after the last dose.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Liang | Contact | 86-18086006235 | 553954881@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 1, 2025 | |
| Reset | Jul 21, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 1, 2025 | Jul 21, 2025 |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| C410216 | Folfox protocol |
| D013812 | Therapeutics |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
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|
| Sintilimab | Drug | 200mg IV d1, Q3W |
|
|
| Bevacizumab Biosimilar IBI305 | Drug | 7.5mg/kg IV d1, Q3W |
|
|
Defined as the incidence of complete response and, partial response |
| From baseline to primary completion date, about 18 months |
| Disease control rate (DCR) per RECIST v1.1 and mRECIST | Defined as the incidence of complete response, partial response and stable disease | From baseline to primary completion date, about 18 months |
| Duration of response (DoR) per RECIST v1.1 and mRECIST | Defined as a duration from date of initial treatment to disease progression or death in patients who achieve complete or partial response | From baseline to primary completion date, about 18 months |
| Overall survival (OS) | Defined as a duration from the date of initial treatment to death of any cause. | From baseline to primary completion date, about 18 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |