Cryoablation Combined with Anti-PD-1 Antibody in Patients with Advanced Intrahepatic Cholangiocarcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Camrelizumab

    Drug

    a PD-1 immune check inhibitor

  • US/CT-guided Percutaneous Cryoablation

    Combination product

    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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Cryoablation in combination with CamrelizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

Objective Response Rate according to modified RECIST for Hepatocellular Carcinoma

Time frame
max 24 months

Secondary outcomes

1

Duration of Response

Time frame
max 24 months
2

Progression Free Survival

Time frame
max 24 months
3

Overall survival

Time frame
max 42 months
4

disease control rate

Time frame
max 24 months

Other outcomes

Sponsors and contacts

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