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HAIC Combined with Tislelizumab and Regorafenib for Advanced Intrahepatic Cholangiocarcinoma: A Single-Arm, Open-Label, Phase II Study

HAIC Combined with Tislelizumab and Regorafenib for Advanced Intrahepatic Cholangiocarcinoma: A Single-Arm, Open-Label, Phase II Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056067
Enrollment
Unknown
Registered
2022-01-31
Start date
2022-01-31
Completion date
Unknown
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

Experimental group:HAIC + Tislelizumab + Regorafenib

Sponsors

The Fifth Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years; 2.ECOG performance status <= 1; 3.Intrahepatic Cholangiocarcinoma; 4.Tumour lesions: Must be accurately measured in at least one dimension (RECIST 1.1); 5.Previous treatment with drug; 6.Good organ and bone marrow function.

Exclusion criteria

Exclusion criteria: 1.Allergic to PD-1/PD-L1 antibodies; 2.Patients who suffer from hypertension and cannot be reduced to the normal range after anti-hypertensive drug treatment; 3.Patients at risk of biliary obstruction; 4.Allergic to the drug of this protocol (Gemcitabine); 5.Patients with a clear tendency to gastrointestinal bleeding; 6.Patients who have immune system diseases and need to use Glucocorticoids and/or ICIs.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Progression-free survival;Disease control rate;Overall survival;Improvement of quality of life;

Countries

China

Contacts

Public ContactYinying Lu

The Fifth Medical Center of Chinese PLA General Hospital

plahyt@163.com+86 13301256799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026