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Atezolizumab plus bevacizumab is the first-line treatment for advanced hepatocellular carcinoma (HCC). However, the effect of the second-line treatment after the progress of Atezolizumab plus bevacizumab therapy remains unsatisfactory. This is a prospective trial to investigate the efficacy and safety of systemic chemotherapy with FOLFOX plus Atezolizumab & bevacizumab as second-line treatment for patients with advanced HCC who previously received atezolizumab plus bevacizumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX+TA | Experimental | Systemic chemotherapy with FOLFOX plus Atezolizumab & bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX | Drug | oxaliplatin 85mg/m2 + leucovorin 400mg/m2 + 5-fu 400mg/m2 + 5-fu 2400mg/m2 46h iv.drip Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR via mRECIST | CR+PR via mRECIST | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | overall survival was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff. | 12 months |
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Inclusion Criteria:
Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
• Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Shi | Contact | 8620-87343115 | shiming@sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ming Shi | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Atezolizumab & Bevacizumab | Drug | Atezolizumab 1200mg iv.drip + Bevacizumab 15mg/kg iv.drip Q3w |
|
| Progression Free Survival (PFS) |
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first. |
| 12 months |
| Adverse Events | Number of adverse events. Postoperative adverse events were graded based on CTCAE | 12 months |
| 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 |
|---|---|
| C410216 | Folfox protocol |
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| 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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