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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

REACH-01：A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239532
• Other study ID #: QLYY-iCCA-01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 27, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Qilu Hospital of Shandong University
• Contact: Zongli Zhang
• Phone: 0531-82166341
• Email: zzlzzl1900[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• 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.
• Tislelizumab
Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks
• Surufatinib
Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	the sum of complete response rate and partial response rate	24 months
Secondary	Progression-free survival (PFS)	Time from randomization to disease progression	24 months
Secondary	Conversion to surgical resection rate	Defined as the proportion of patients who were successfully converted to radical resection with negative hepatic margins after the study treatment regimen was calculated	3 months
Secondary	Overall survival (OS)	Time from randomization to death for any cause	24 months
Secondary	1-year overall survival rate	one year overall survival rate	12 months
Secondary	Disease Control rate (DCR)	the sum of complete response rate, partial response rate and stable disease rate	24 months
Secondary	Incidence rate of adverse events	Defined as the proportion of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0	24 months