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This is a Phase Ib study to evaluate the safety and efficacy of sintilimab combined with bevacizumab biosimilar in patients with potentially resectable intermediate hepatocellular carcinoma (HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab+Bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab: 200mg IV Q3W D1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | 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; Surgical safety including Intraoperative blood loss,PHLF assessed by ISGLS(2012),Postoperative complications evaluated by modified Clavien-Dindo system | Up to 2 years |
| Events Free Survival (EFS) Assessed by RECIST1.1 | Defined as the time from enrollment to disease progression, recurrence or death (whichever occurs first) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| resection rate (R0 resection rate) | Defined as the proportion of patients undergoing radical resection to the total subjects (R0 resection rate) | Up to 2 years |
| Pathological response rate | Defined as the proportion of patients who had pathological response. |
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Inclusion Criteria:
Able to provide informed consent and willing to sign an approved consent form
Age 18-75, male and female
Potentially resectable Intermediate (CNLC-IIa and IIb) HCC with diagnosis confirmed by histology/cytology or clinically
No prior therapy for HCC
Child-Pugh: A
ECOG PS: 0-1
Expected survival ≥6 months
Measurable disease per RECIST1.1
Major organ functions meet the following requirements:
no blood transfusion, no use of hematopoietic stimulators (including g-csf, gm-csf, EPO and TPO) and infusion of human albumin preparations within 14 days prior to screening: neutrophil absolute count ≥1.0×10^9/L;Platelet count ≥ 75×10^9/L;Hemoglobin ≥ 9 g/dL;Serum albumin ≥ 2.8 g/dL;Total serum bilirubin ≤2.0× upper limit of normal range (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;Serum creatinine (Cr) ≤1.5×ULN or Cr clearance ≥30 mL/min (calculated by Cockcroft-Gault formula);International standardized ratio (INR) ≤1.5×ULN;
Women of childbearing age must undergo a blood pregnancy test within the first 3 days of randomization with negative results and agree to use a reliable and effective method of contraception during the trial and within 120 days of the last trial drug administration. Male patients whose partners are women of childbearing age must agree to use a reliable and effective method of contraception during the trial and within 120 days of the last trial drug administration.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huichuan Sun | Contact | 13701922065 | sun.huichuan@zs-hospital.sh.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40046248 | Derived | Sun HC, Zhu XD, Wang ZY, Gao Q, Ji Y, Shi YH, Wang XY, Qiu SJ, Huang C, Shen YH, Zhou J, Fan J. Sintilimab plus bevacizumab followed by resection in intermediate-stage hepatocellular carcinoma: a phase Ib clinical trial with biomarker analysis. BMJ Oncol. 2024 Dec 16;3(1):e000578. doi: 10.1136/bmjonc-2024-000578. eCollection 2024. |
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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 |
|---|---|
| C000632826 | sintilimab |
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| Bevacizumab Biosimilar |
| Drug |
Bevacizumab biosimilar: 15mg/kg, IV, Q3W, D1 |
|
| Up to 2 years |
| Objective response rate (ORR) assessed by RECIST1.1 | Defined as the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR). | Up to 2 years |
| Recurrence-free survival (RFS) of patients who accepted surgery | Defined as the time from the date of surgery to the date of disease recurrence or death whichever occur first, assessed up to 2 years post-treatment | Up to 2 years |
| Progression free survival (PFS) assessed by RECIST1.1 of patients who didn't accept surgery | Defined as the time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first. | Up to 2 years |
| Overall survival (OS) of the patients who accepted surgery | Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive. | Up to 2 years |
| Overall survival (OS) of the patients who didn't accepted surgery | Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive. | Up to 2 years |
| Overall survival (OS) | Defined as the time from the date of treatment start to the date of death or to the date of last follow-up for patients alive | Up to 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |