HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-27

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intrahepatic Cholangiocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAE+HAIC+Tislelizumab+Surufatinib

Patients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib

Group Type EXPERIMENTAL

HAIC+TAE

Intervention Type DRUG

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.

Tislelizumab

Intervention Type DRUG

Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks

Surufatinib

Intervention Type DRUG

Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.

Interventions

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HAIC+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.

Intervention Type DRUG

Tislelizumab

Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks

Intervention Type DRUG

Surufatinib

Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No