Cryoablation Combined With SHR-1701 Plus Famitinib in Patients With Advanced 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
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
Treatments tested in this trial
- SHR-1701
- Famitinib
- Cryoablation
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov