NCT05290116

HAIC Combined With Tislelizumab and Apatinib for Unresectable Intrahepatic Cholangiocarcinoma

Status unknown Phase 2 Last updated 5 August 2022

What this trial tests

Phase 2 trial testing HAIC Combined with Tislelizumab and Apatinib in Intrahepatic Cholangiocarcinoma in 17 participants. Status unknown.

Timeline

21 July 2022

Primary endpoint
1 May 2023

1 September 2023

Quick facts

Lead sponsor	Yunfei Yuan
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	21 July 2022
Primary completion	1 May 2023
Estimated completion	1 September 2023
Sites	1 location across China

Drugs / interventions tested

• HAIC Combined with Tislelizumab and Apatinib — full drug profile →

Conditions studied

• Intrahepatic Cholangiocarcinoma — all drugs for Intrahepatic Cholangiocarcinoma →

Sponsor

Yunfei Yuan

Who can join

Adults 18 to 75, any sex, with Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with tislelizumab and apatinib in the treatment of unresectable ICC.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current and Emerging Therapeutic Targets for the Treatment of Cholangiocarcinoma: An Updated Review.
   Hadfield MJ, DeCarli K, Bash K, Sun G, et al · · 2023 · cited 12× · PMID 38203714 · DOI 10.3390/ijms25010543
2. Intrahepatic cholangiocarcinoma: Evolving role of neoadjuvant and targeted therapy.
   Ghio M, Vijay A. · · 2023 · cited 9× · PMID 36823963 · DOI 10.14701/ahbps.22-110
3. Update on Locoregional Therapies for Cholangiocellular Carcinoma.
   Morawitz J, Bruckmann NM, Jannusch K, Kirchner J, et al · · 2023 · cited 5× · PMID 37190295 · DOI 10.3390/cancers15082368
4. Management of intrahepatic cholangiocarcinoma: a review for clinicians.
   Colangelo M, Di Martino M, Polidoro MA, Forti L, et al · · 2025 · cited 3× · PMID 39867595 · DOI 10.1093/gastro/goaf005