TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04954781|
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : July 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholangiocarcinoma||Drug: Tislelizumab Combination Product: TACE||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Transcatheter Arterial Chemoembolization (TACE) Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma|
|Actual Study Start Date :||July 14, 2021|
|Estimated Primary Completion Date :||July 15, 2023|
|Estimated Study Completion Date :||July 15, 2024|
|Experimental: TACE in combination with Tislelizumab||
Tislelizumab will be initiated on day 14 after the first TACE session. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Combination Product: TACE
TACE is performed by using drug-eluting beads. TACE treatment starts on day 0. The second TACE will be repeated on day 28 (± 5 days) if necessary per Investigator's decision.
- Objective Response Rate (ORR) [ Time Frame: max 24 months ]ORR according to RECIST 1.1 for advanced intrahepatic cholangiocarcinoma.
- Duration of Response [ Time Frame: max 24 months ]
- Progression-Free Survival [ Time Frame: max 24 months ]
- Overall survival [ Time Frame: max 42 months ]
- Disease control rate [ Time Frame: max 24 months ]
- Adverse Events [ Time Frame: max 42 months ]Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04954781
|Contact: Peng Wang, MDemail@example.com|
|Fudan University Shanghai Cancer Center||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Peng Wang, Doctor 8621-64175590 ext 83630 firstname.lastname@example.org|
|Principal Investigator: Peng Wang, Doctor|
|Principal Investigator:||Peng Wang, MD||Fudan University|