Health TrialsbyHealthPanel

TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

ConditionIntrahepatic 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 TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma 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 the 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.

RFA 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

  • Tislelizumab

    Drug

    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.

  • TACE

    Combination product

    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.

Treatment groups

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

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR according to RECIST 1.1 for advanced intrahepatic cholangiocarcinoma.

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

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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