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

Shandong University

Status and phase: Active, not recruiting; Phase 2

Conditions: Intrahepatic Cholangiocarcinoma

Treatments: Drug: Surufatinib; Drug: HAIC+TAE; Drug: Tislelizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06239532

REACH-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

28 participants in 1 patient group

TAE+HAIC+Tislelizumab+Surufatinib

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab

Drug: HAIC+TAE

Drug: Surufatinib