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Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced Intrahepatic Cholangiocarcinoma.

ConditionAdvanced Intrahepatic Cholangiocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This study will evaluate the efficacy and safety of cryoablation combined with SHR-1701, a bifunctional fusion protein targeting PD-L1 and TGF-β, plus famitinib, a multi-targeted receptor tyrosine kinase inhibitor, in patients with advanced Intrahepatic Cholangiocarcinoma (ICC) who have progressed after first-line treatment.

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 GemCis plus PD1/PD-L1 inhibitor 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.

Prior treatment with cryoablation.

RFA and resection administered less than 4 weeks prior to study treatment start.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-1701

    Drug

    SHR-1701 will be administered by IV, 1200mg on day 1 of each 21 day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

  • Famitinib

    Drug

    Famitinib will be administered at 15 mg orally daily until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

  • Cryoablation

    Procedure/Surgery

    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. SHR-1701 plus famitinib will be administered 1-3 days after cryoablation.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Cryoablation combined with SHR-1701 plus famitinibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
max 24 months

Secondary outcomes

1

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).

Time frame
max 24 months
2

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.

Time frame
max 24 months
3

Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed

Time frame
max 24 months
4

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).

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

This trial is not recruiting at the moment. You can still explore other options: