NCT04217954

HAIC With Oxaliplatin, 5-FU and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC

Completed Phase 2 Last updated 23 June 2023

What this trial tests

Phase 2 trial testing OXA, 5-FU and bevacizumab plus Toripalimab in Advanced Biliary Tract Cancer in 32 participants. Completed in 1 June 2023.

Timeline

28 July 2020

Primary endpoint
19 May 2023

1 June 2023

Quick facts

Lead sponsor	Peking University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	28 July 2020
Primary completion	19 May 2023
Estimated completion	1 June 2023
Sites	1 location across China

Drugs / interventions tested

• OXA, 5-FU and bevacizumab plus Toripalimab — full drug profile →

Conditions studied

• Advanced Biliary Tract Cancer — all drugs for Advanced Biliary Tract Cancer →

Sponsor

Peking University

Who can join

Adults 18 to 80, any sex, with Advanced Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatic arterial infusion chemotherapy (HAIC) deliver high concentration of chemotherapeutic agents directly to the liver tumor, was proved to be effective for intrahepatic and perihilar cholangiocarcinoma. Based on the potential synergistic effect of bevacizumab, chemotherapy and PD-1 inhibitor, this phase II clinical study want to test the efficacy and safety using intra-arterial infusion of oxaliplatin, 5-fluorouracil and bevacizumab combined with intravenous infusion of PD-1 inhibitor (Toripalimab) in the treatment of unresectable biliary malignant tumors.

Publications & conference data

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

1. Changing Landscape of Systemic Therapy in Biliary Tract Cancer.
   Woods E, Le D, Jakka BK, Manne A. · · 2022 · cited 31× · PMID 35565266 · DOI 10.3390/cancers14092137
2. Biliary Tract Cancers: Treatment Updates and Future Directions in the Era of Precision Medicine and Immuno-Oncology.
   Manne A, Woods E, Tsung A, Mittra A. · · 2021 · cited 29× · PMID 34868996 · DOI 10.3389/fonc.2021.768009
3. Recent Advances in Immunotherapy for Advanced Biliary Tract Cancer.
   Yue S, Zhang Y, Zhang W. · · 2024 · cited 11× · PMID 39066855 · DOI 10.1007/s11864-024-01243-y
4. Targeting Angiogenesis in the Era of Biliary Tract Cancer Immunotherapy: Biological Rationale, Clinical Implications, and Future Research Avenues.
   Schirizzi A, De Leonardis G, Lorusso V, Donghia R, et al · · 2023 · cited 9× · PMID 37190304 · DOI 10.3390/cancers15082376
5. Preclinical and clinical studies of immunotherapy for the treatment of cholangiocarcinoma.
   Lu X, Green BL, Xie C, Liu C, et al · · 2023 · cited 6× · PMID 37229173 · DOI 10.1016/j.jhepr.2023.100723
6. Targeted therapies for extrahepatic cholangiocarcinoma: preclinical and clinical development and prospects for the clinic.
   Cadamuro M, Lasagni A, Lamarca A, Fouassier L, et al · · 2021 · cited 6× · PMID 33622120 · DOI 10.1080/13543784.2021.1880564
7. Phase II trial of hepatic arterial infusion chemotherapy plus bevacizumab and toripalimab for advanced biliary tract cancers: efficacy, safety, and exploratory analysis.
   Zheng K, Fu S, Zhu X, Cao G, et al · · 2026 · PMID 41983220 · DOI 10.21037/hbsn-24-463