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

NCT06239532 | Active Not Recruiting Phase 2

• 1 other identifier: REACH-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  the sum of complete response rate and partial response rate

  24 months

Secondary Outcomes (6)

• Progression-free survival (PFS)

  24 months

• Conversion to surgical resection rate

  3 months

• Overall survival (OS)

  24 months

• 1-year overall survival rate

  12 months

• Disease Control rate (DCR)

  24 months

Study Arms (1)

TAE+HAIC+Tislelizumab+Surufatinib

EXPERIMENTAL

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

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

Interventions

HAIC+TAE 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.

TAE+HAIC+Tislelizumab+Surufatinib

Tislelizumab DRUG

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

TAE+HAIC+Tislelizumab+Surufatinib

Surufatinib DRUG

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

TAE+HAIC+Tislelizumab+Surufatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent for the trial.
• Aged ≥18 years.
• Histologically confirmed intrahepatic cholangiocarcinoma.
• No other previous systematic treatment for BTC.
• At least one measurable lesion (RECIST 1.1).
• Eastern Cooperative Oncology Group performance status 0 or 1.
• Life expectancy of 3 months or greater.
• Child-Pugh classification score ≤7.

You may not qualify if:

• Recurrent patients.
• Eastern Cooperative Oncology Group performance status ≥ 2.
• Life expectancy of less than 3 months.
• Child-Pugh classification score \> 8.
• History of hepatic encephalopathy or liver transplantation.
• Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
• Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
• Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.
• Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.).
• History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
• The researcher considers it inappropriate to enter this study.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• BeiGene: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• Li KS, Liu Y, Zhang TZ, Xu YF, Zhang ZL. Protocol of REACH-01: a single-arm, open label, prospective study of HAIC sequential TAE combined with tislelizumab and surufatinib in unresectable intrahepatic cholangiocarcinoma. Front Pharmacol. 2024 Nov 18;15:1435639. doi: 10.3389/fphar.2024.1435639. eCollection 2024.

  PMID: 39624833 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

tislelizumab; surufatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Zongli Zhang

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: February 2, 2024
• Study Start: September 27, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)