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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05781074
Other study ID # 2212266-15
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 23, 2023
Est. completion date December 30, 2025

Study information

Verified date March 2023
Source Fudan University
Contact Peng Wang, MD
Phone 86-21-64175590
Email wangp413@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with Immune Checkpoint Inhibitor previously treated advanced biliary tract cancer (BTC).


Description:

Recent studies have suggested that local destruction of tumor tissue by cryoablation induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. While pd-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. And combination of pd-1 blocking antibody plus lenvatinib showed increased ORR in many type of human cancers. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with Immune Checkpoint Inhibitor previously treated advanced BTC.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sintilimab
a PD-1 immune checkpoint inhibitor
Lenvatinib
Lenvatinib capsules
Procedure:
Cryoablation
Cryoablation is performed under US or CT guidance per Investigator decision

Locations

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator. max 24 months
Secondary Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment. max 24 months
Secondary Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first) max 24 months
Secondary Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death max 24 months
Secondary Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD). max 24 months
Secondary Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported. max 42 months
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