A Phase II Study of Cryoablation Combined with Sintilimab Plus Lenvatinib in Patients with Advanced Intrahepatic Cholangiocarcinoma (CASTLE-01)

Fudan University1 site in 1 country28 target enrollmentAugust 24, 2021

ConditionsIntrahepatic Cholangiocarcinoma

Interventionscryoablation Sintilimab lenvatinib

Drugscryoablation Sintilimab lenvatinib

Overview

Phase: Phase 2
Intervention: cryoablation
Conditions: Intrahepatic Cholangiocarcinoma
Sponsor: Fudan University
Enrollment: 28
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic Cholangiocarcinoma after progression on first line systemic therapy.

Detailed 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, including advanced intrahepatic cholangiocarcinoma. Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic cholangiocarcinoma.

Registry

clinicaltrials.gov

Start Date

August 24, 2021

End Date

March 2, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Peng Wang

Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

•Written informed consent obtained.
•Age ≥ 18 years at time of study entry.
•Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma
•Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity.
•At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
•Performance status (PS) ≤ 2 (ECOG scale).
•Life expectancy of at least 12 weeks.
•Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
•Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
•Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

Exclusion Criteria

•History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
•Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
•Prior treatment with cryoablation.
•Prior treatment with Lenvatinib or other targeted therapy.
•RFA and resection administered less then 4 weeks prior to study treatment start.
•Radiotherapy administered less then 4 weeks prior to study treatment start.
•Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
•Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
•Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
•Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.