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The goal of this clinical trial is to learn about the combined therapy using drug-eluting bead-transarterial chemoembolization (D-TACE), gemcitabine (Gem) and cisplatin (Cis) chemotherapy, and PD-1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma (ICC). The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and Camrelizumab | Experimental | D-TACE with cisplatin-eluting beads. More TACE can be done if clinically necessary. Camrelizumab (200 mg, Intravenous drips (ivd), D1/3W) plus Gem (1000 mg/m2, ivd, D1&8/3W) and Cis (25 mg/m2, ivd, D1&8/3W). Three weeks are one cycle of treatment. Chemotherapy lasted for no more than 12 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 200mg on day1 of every 3 weeks, starting on day1 of cycle1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate | Rate of unresectable ICC convert to resectable in combination therapy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Rate of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |
| Objective Response Rate (ORR) | ORR according to RECIST 1.1 using investigator assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Li, MD&PhD | Contact | +8613060975202 | lihua100@yeah.net | |
| Linsen Ye, MD&PhD | Contact | +8618520788663 | ye_linsen@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Yang, MD&PhD | Third Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | China |
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| Gemcitabine Injection | Drug | 1000mg/m2 on day1 & day8 of every 3 weeks, starting on day1 of cycle 1 |
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| Cisplatin injection | Drug | 25mg/m2 on day1 & day8 of every 3 weeks, starting on day1 of cycle 1 |
|
| Cisplatin-Eluting Beads | Drug | used for D-TACE |
|
| D-TACE | Procedure | TACE with Cisplatin-Eluting Beads (with Cis 30mg). More TACE can be done if clinically necessary. |
|
| 12 months |
| Deepness of response (DpR) | DpR according to RECIST 1.1 using investigator assessment | 12 months |
| Disease control rate (DCR) | DCR according to RECIST 1.1 using investigator assessment | 12 months |
| Rate of R0 resection | R0 resection is defined as no tumor remains at the cutting edge and no tumor cells remain at the cutting edge under the microscope | 12 months |
| Overall Survival (OS) | OS is defined as the time from date of combined theray start to the date of death from any cause or to the date of last follow-up if patients are alive. | 12 months |
| Progression-free Survival (PFS) | From the beginning date of combined therapy to the date of disease progression. PFS according to RECIST 1.1 using investigator assessment | 12 months |
| Recurrence-free Survival (RFS) | RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. RFS according to RECIST 1.1 using investigator assessment | 12 months |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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