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This is a multicenter, retrospective cohort study that aims to evaluate the efficacy and safety of a triple-drug cocktail (TCC), consisting of Thalidomide, Carmofur, and Compound Mylabris Capsules (CMC), in combination with conventional Transarterial Chemoembolization (TACE) for the treatment of patients with unresectable Hepatocellular Carcinoma (HCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE+cocktail | Patients in the TACE+cocktail group received TACE and took the combined oral medications daily, which consisted of thalidomide tablets, carmofur tablets , and compound mylabris capsule. |
| |
| TACE only | Patients in the TACE only group received only TACE treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide (50mg) | Drug | Thalidomide tablets (Changzhou Pharmaceutical Factory, 50 mg qn) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time interval from the date of the patient's first TACE treatment to the date of death from any cause or the date of the last follow-up (whichever occurred first). | up to five years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) at 6 Months | The proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to mRECIST criteria at the 6-month follow-up after treatment initiation. | up to six months |
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Inclusion Criteria:
Exclusion Criteria:
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This multicenter, retrospective cohort study included adult patients (≥18 years old) diagnosed with unresectable hepatocellular carcinoma (HCC). The diagnosis was made according to the Chinese guidelines for the diagnosis and treatment of primary liver cancer (relevant edition). All patients received initial treatment with conventional transarterial chemoembolization (TACE).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| C017367 | carmofur |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| carmofur |
| Drug |
carmofur tablets (Qilu Pharmaceutical, 100 mg, tid) |
|
| compound mylabris capsule | Drug | CMC (Guizhou Yibai Pharmaceutical Co., Ltd, 750 mg, bid) |
|
| TACE | Procedure | received initial treatment with traditional TACE by well-trained and experienced physicians |
|
| D008107 |
| Liver Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |