Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Based on different patterns of disease progression, patients will receive relevant systemic treatments, either with or without local interventional therapy. The primary endpoint is progression-free survival (PFS), while secondary endpoints include overall survival (OS), 1-year OS rate, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and safety. Additionally, the study will explore the correlation between patients' clinical pathological characteristics, serum biomarkers, and clinical efficacy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | XELOX/FOLFOX4+ Adebelizumab + Apatinib+Icaritin |
|
| Arm 2 | Experimental | Adebelizumab + Apatinib+Icaritin |
|
| Arm 3 | Experimental | SHR1701+ Apatinib+Icaritin |
|
| Arm 4 | Experimental | QL1706+ Apatinib+Icaritin |
|
| Arm 5 | Experimental | The original targeted combination immunotherapy+HAIC |
|
| Arm 6 | Experimental | SHR1701+ Apatinib+Icaritin,intrahepatic progression |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFOX4 | Drug | FOLFOX4 was administered by oxaliplatin 85 mg/m² d1+ leucovorin 200 mg/m² d1-2+ fluorouracil 400 mg/m² 2 h→ 600 mg/m² 24 h d1-2 q2w, with a total of 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS(Progression-free Survival) | Progression-free survival (PFS) was defined as the time from treatment initiation on Day 1 to the earliest occurrence of radiologically confirmed disease progression, as assessed by tumor imaging, or death from any cause, whichever came first. Evaluations were conducted by the investigator in accordance with RECIST v1.1. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS(Overall survival) | Overall survival (OS) was defined as the duration from treatment initiation on Day 1 to death from any cause. | 48 months |
| ORR(Objective response rate) | Objective response rate (ORR) was defined as the proportion of subjects achieving a complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1, from the initiation of treatment on Day 1. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Xun | Contact | +86-13851670770 | mxrlwx19911990@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Pharmaceutical University Affiliated Nanjing Tianyinshan Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C410216 | Folfox protocol |
| C553458 | apatinib |
| C499403 | icaritin |
| C000723862 | SHR-1701 |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Arm 7 | Experimental | QL1706+ Apatinib+Icaritin,extrahepatic progression |
|
| Arm 8 | Experimental | SHR1701+Bevacizumab+Icaritin |
|
| Arm 9 | Experimental | QL1706+Bevacizumab+Icaritin |
|
| Arm 10 | Experimental | Local treatment of oligometastases (such as radiotherapy, RFA, etc.) + the original targeted and immunotherapy. |
|
| Adebrelimab | Drug | Adebrelimab 1200mg, intravenous infusion, every 3 weeks |
|
| Apatinib | Drug | Apatinib 250mg, oral, once daily. |
|
| Icaritin | Drug | Epimedium extract soft capsules 2.4g, oral, 2 times daily. |
|
| SHR-1701 | Drug | SHR1701,30mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most. |
|
| QL1706 | Drug | QL1706,5mg/kg, intravenous infusion, every 3 weeks, use for up to 2 years at most. |
|
| Bevacizumab | Drug | Bevacizumab 7.5mg, intravenous infusion, once every 3 weeks. |
|
| HAIC | Procedure | Hepatic Arterial Infusion Chemotherapy |
|
| Local treatment | Procedure | Local treatment of oligo-metastases. |
|
| The original treatment regimen | Drug | Continue the original targeted therapy combined with immunotherapy. dosage, dosage form,frequency of administration was the same as before. |
|
| 24 months |
| DCR(Disease control rate ) | Disease control rate (DCR) was defined as the proportion of subjects achieving a complete response (CR), partial response (PR), or stable disease (SD) lasting ≥8 weeks, as assessed by the investigator according to RECIST v1.1, from the initiation of treatment on Day 1. | 24 months |
| DOR(Duration of Response) | Duration of response (DOR) was defined as the time from the first documented objective response (CR or PR) to the earliest occurrence of radiological disease progression or death from any cause, whichever occurred first. Both response and progression were evaluated by the investigator according to RECIST v1.1. | 24 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |