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This study aims to evaluate the efficacy and safety of Sintilimab (an Anti-PD-1 Inhibitor) combined with apatinib and capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab+Apatinib+Capecitabine | Experimental | =Drug: Sintilimab(i.v)+apatinib(p.o)+capecitabine(p.o) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab Combined With Apatinib and Capecitabine | Drug | Drug: Sintilimab 200mg (3mg/kg for underweight patients) intravenously, every 21 days for a cycle; Drug: Apatinib,250mg po qd, for continuous medication; Drug: Capecitabine,1000mg/m2 po bid, d1-d14, every 21 days for a cycle; |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | 1 year after the last patient's enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | 1 year after the last patient's enrollment |
| Duration of Response (DoR) |
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Inclusion Criteria:
Patient has given written informed consent.
Age between 18-75 years old.male or female.
Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1 standard.
Subjects haven't received any systemic treatment that includes target-therapy, immunotherapy or chemotherapy for HCC before admission.
liver function status Child-Pugh Class A; Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C;
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
Expected survival ≥12 weeks
The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinhua Xu, Master | Contact | +8613986747496 | +8613986747496 | 2732774352@qq.com |
| Lu Xu, Phd | Contact | +8613972032135 | xlnick@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University | Recruiting | Yichang | Hubei | 443003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36091003 | Derived | Li D, Xu L, Ji J, Bao D, Hu J, Qian Y, Zhou Y, Chen Z, Li D, Li X, Zhang X, Wang H, Yi C, Shi M, Pang Y, Liu S, Xu X. Sintilimab combined with apatinib plus capecitabine in the treatment of unresectable hepatocellular carcinoma: A prospective, open-label, single-arm, phase II clinical study. Front Immunol. 2022 Aug 26;13:944062. doi: 10.3389/fimmu.2022.944062. eCollection 2022. |
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| 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 |
|---|---|
| C553458 | apatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
| 1 year after the last patient's enrollment |
| Overall survival(OS) | the date of Death of any causes since the date of enrollment | 1 year after the last patient's enrollment |
| Progression-free survival(PFS) | Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). | 1 year after the last patient's enrollment |
| Safety as measured by the rate of AEs | The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | 1 year after the last patient's enrollment |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |