Intrahepatic Cholangiocarcinoma
Conditions
Brief summary
This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.
Detailed description
Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. All patients were treated with HAIC (Oxaliplatin and Raltitrexed ). Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time； Tislelizumab was given 200mg every 3 weeks. The treatment continued until the patient developed the disease or met the other criteria for terminating the study.
Interventions
DRUGHAIC+TAE
Procedure: 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.
DRUGTislelizumab
Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks
DRUGSurufatinib
Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.
Sponsors
BeiGene
Qilu Hospital of Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 0 or 1. 7. Life expectancy of 3 months or greater. 8. Child-Pugh classification score ≤7.
Exclusion criteria
1. Recurrent patients. 2. Eastern Cooperative Oncology Group performance status ≥ 2. 3. Life expectancy of less than 3 months. 4. Child-Pugh classification score \> 8. 5. History of hepatic encephalopathy or liver transplantation. 6. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. 7. Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage. 8. Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus. 9. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.). 10. History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis. 11. The researcher considers it inappropriate to enter this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 24 months | the sum of complete response rate and partial response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year overall survival rate | 12 months | one year overall survival rate |
| Disease Control rate (DCR) | 24 months | the sum of complete response rate, partial response rate and stable disease rate |
| Incidence rate of adverse events | 24 months | Defined as the proportion of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 |
| Conversion to surgical resection rate | 3 months | Defined as the proportion of patients who were successfully converted to radical resection with negative hepatic margins after the study treatment regimen was calculated |
| Overall survival (OS) | 24 months | Time from randomization to death for any cause |
| Progression-free survival (PFS) | 24 months | Time from randomization to disease progression |
Countries
China
Outcome results
None listed