- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04299581
Cryoablation Combined With Anti-PD-1 Antibody in Patients With Advanced Intrahepatic Cholangiocarcinoma
September 12, 2023 updated by: Peng Wang, Fudan University
A Phase II Study of Cryoablation Combined With Anti-PD-1 Antibody (SHR-1210) in Patients With Advanced Intrahepatic Cholangiocarcinoma
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with anti-pd-1 antibody in patients with advanced hepatocellular carcinoma after progression on first line systemic therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Therefore, the objective of this study is to evaluate the efficacy and safety of cryoablation combined with anti-pd-1 antibody in patients in advanced intrahepatic cholangiocarcinoma.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peng Wang, MD
- Phone Number: 86-21-64175590
- Email: wangp413@163.com
Study Locations
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Shanghai, China
- Recruiting
- Fudan University Shanghai Cancer Center
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Contact:
- Peng Wang, MD
- Phone Number: 86-21-64175590
- Email: wangp413@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
- Radiofrequency ablation 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.
Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:
- history of interstitial lung disease
- Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
- known acute or chronic pancreatitis
- active tuberculosis
- any other active infection (viral, fungal or bacterial) requiring systemic therapy
- history of allogeneic tissue/solid organ transplant
- diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of nivolumab-monotherapy treatment.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.
- Live vaccine within 30 days prior to the first dose of nivolumab-monotherapy treatment or during study treatment.
- History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of nivolumab-monotherapy treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.
- Medication that is known to interfere with any of the agents applied in the trial.
- Any other efficacious cancer treatment except protocol specified treatment at study start.
- Patient has received any other investigational product within 28 days of study entry.
- Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year). [Acceptable methods of contraception are: implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cryoablation in combination with Camrelizumab
Cryoablation treatment starts at day 1.
Camrelizumab will be initiated on day 14 after Cryoablation.
Camrelizumab will be administered every three weeks (3mg/Kg, IV) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
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Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone
a PD-1 immune check inhibitor
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: max 24 months
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Objective Response Rate according to modified RECIST for Hepatocellular Carcinoma
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max 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response
Time Frame: max 24 months
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max 24 months
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Progression Free Survival
Time Frame: max 24 months
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max 24 months
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Overall survival
Time Frame: max 42 months
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max 42 months
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disease control rate
Time Frame: max 24 months
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max 24 months
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Adverse Events
Time Frame: max 42 months
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Adverse event (AE)、Treatment emergent adverse event(TEAE)、Serious adverse event (SAE)
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max 42 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhiqiang Meng, MD, Fudan University
- Principal Investigator: Peng Wang, MD, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2020
Primary Completion (Estimated)
May 10, 2024
Study Completion (Estimated)
May 10, 2024
Study Registration Dates
First Submitted
March 5, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 9, 2020
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1905201-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intrahepatic Cholangiocarcinoma
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Emory UniversityNational Cancer Institute (NCI)WithdrawnStage II Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Resectable Intrahepatic Cholangiocarcinoma | Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8 | Stage I Intrahepatic Cholangiocarcinoma AJCC v8United States
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