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Trial Title:
HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
NCT ID:
NCT06239532
Condition:
Intrahepatic Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HAIC+TAE
Description:
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.
Arm group label:
TAE+HAIC+Tislelizumab+Surufatinib
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks
Arm group label:
TAE+HAIC+Tislelizumab+Surufatinib
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules
(50mg/capsule) each time.
Arm group label:
TAE+HAIC+Tislelizumab+Surufatinib
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Zongli Zhang
Investigator:
Last name:
Zongli Zhang
Email:
Principal Investigator
Start date:
September 27, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Collaborator:
Agency:
BeiGene
Agency class:
Industry
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06239532
