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To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.
This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy, including anti-PD1+anti-VEGF, anti-PD1+TKI and anti-PD1+anti-CTLA4. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC cohort 1: Sintilimab plus bevacizumab biosimilar |
| ||
| HCC cohort 2: Camrelizumab plus Rivoceranib |
| ||
| HCC cohort 3: O+Y |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab will be administered by IV, 200 mg every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator. | max 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD). | max 24 months |
| Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 |
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Inclusion Criteria:
Age ≥ 18 years at time of study entry.
Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies.
HCC confirmed by radiology, histology or cytology.
No prior systemic therapy for HCC.
At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI.
Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
Adequate organ function:
Willing to provide archival/fresh tumor tissue and peripheral blood samples.
Signed informed consent.
Exclusion Criteria:
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Patients with advanced hepatocellular carcinoma planed to receive first-line immunotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Wang, MD | Contact | 86-21-64041990 | peng_wang@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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A baseline tumor biopsy and blood collection before initiation of treatment, followed by a second tumor biopsy with paired blood collection after the first response evaluation will be planned.
| Bevacizumab Biosimilar | Drug | Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks. |
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| Camrelizumab | Drug | Camrelizumab will be administered by IV, 200 mg every 2 weeks. |
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| Rivoceranib | Drug | Rivoceranib will be administered by oral 250 mg once daily. |
|
| Nivolumab | Drug | Nivolumab will be administered by IV, 1 mg/kg every 3 weeks for up to four doses, followed by nivolumab 480 mg every 4 weeks |
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| Ipilimumab | Drug | Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses. |
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DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment. |
| max 24 months |
| Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed. | max 24 months |
| Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first) | max 24 months |
| Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 | OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death. | max 42 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported. | max 42 months |
| Translational study | Proportion of different immune cell types in tumors and blood based on RNA sequencing between two groups. | max 24 months |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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