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HAIC+TAE

Phase 2

Intrahepatic Cholangiocarcinoma | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Nov 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06239532HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic CholangiocarcinomaPHASE2 ACTIVE NOT_RECRUITING 28Sep 27, 2022Dec 31, 2025Nov 21, 20241 China
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Study Endpoints
Primary Endpoints
Objective response rate (ORR)
24 months

the sum of complete response rate and partial response rate

Secondary Endpoints
Progression-free survival (PFS)
24 months
Conversion to surgical resection rate
3 months
Overall survival (OS)
24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAE+HAIC+Tislelizumab+SurufatinibEXPERIMENTALPatients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib
Interventions
NameTypeDescription
HAIC+TAEDRUGProcedure: HAIC+TAE After successful percutaneous hepatic artery cannulation for continuous pumping of drugs. Oxaliplatin(85 mg/m2); Raltitrexed (3 mg/m2) ,continuous infusion for 3 hours. HAIC was performed at an interval of at least 21 days.
TislelizumabDRUGDrug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks
SurufatinibDRUGDrug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Written informed consent for the trial. 2. Aged ≥18 years. 3. Histologically confirmed intrahepatic cholangiocarcinoma. 4. No other previous systematic treatment for BTC. 5. At least one measurable lesion (RECIST 1.1). 6. Eastern Cooperative Oncology Group performance status ...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06239532studyFirstPostDate: changed