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Poster session 13

60P - A phase II trial of hepatic arterial infusion chemotherapy and bevacizumab in combination with toripalimab for advanced biliary tract cancers: Interim report

Date

10 Sep 2022

Session

Poster session 13

Topics

Clinical Research;  Targeted Therapy;  Immunotherapy;  Image-Guided Therapy

Tumour Site

Hepatobiliary Cancers

Presenters

Xiaodong Wang

Citation

Annals of Oncology (2022) 33 (suppl_7): S19-S26. 10.1016/annonc/annonc1036

Authors

X. Wang1, S. Fu2, K. Zheng2, G. Cao3, L. Xu1, R. Yang1, X. Zhu2, P. Liu2, S. Gao2, H. Xu1, J. Guo3, H. Chen1, K. Wang4, J. Li5, J. Zhou5, X. Zhang5, C. Hao4, B. Xing4, L. Shen5

Author affiliations

  • 1 Department Of Interventional Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
  • 2 Department Of Interventional Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Peking University Cancer Hospital & Institute, 100142 - beijing/CN
  • 3 Department Of Interventional Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Peking University Cancer Hospital & Institute, beijing/CN
  • 4 Department Of Hepatic & Biliary Surgery, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
  • 5 Department Of Gi Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing),Peking University Cancer Hospital & Institute, 100142 - Beijing/CN
More

Abstract 60P

Background

The prognosis of first-line standard chemotherapy for advanced biliary tract cancers (BTCs) is still unsatisfactory. Based on phase Ⅲ trial TOPAZ-1, chemotherapy plus PD-L1 inhibitor had shown positive survival improvement. Other evidence showed that VEGF inhibitor could modify tumor immune-microenvironment while hepatic arterial infusion chemotherapy (HAIC) could improve the survival in cholangiocarcinoma. Combining these modalities may improve outcomes. Here we conducted a prospective study to evaluate the efficacy and safety of HAIC combined with bevacizumab (VEGF inhibitor) and toripalimab (PD-1 inhibitor) for advanced BTCs.

Methods

Patients with advanced untreated BTCs were recruited. The combination regimen was composed of hepatic arterial bevacizumab (300mg for 2h d1), followed by oxaliplatin (40 mg/m2 for 2h, days 1-3) and 5-fluorouracil (800 mg/m2 for 22h, days 1-3), with intravenous toripalimab (240 mg) on day 1 prior to HAIC, every 4 weeks. A maximum of six consecutive HAIC cycles. Then toripalimab (240mg) and bevacizumab (300mg) were intravenously infused every four weeks as maintenance treatment. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate(ORR), which was evaluated according to imRECIST, progression-free survival (PFS), and safety.

Results

Between 10/2019-12/2021, 32 patients were enrolled. The median follow-up time was 15.3 months. The ORR was 81.3%, and the disease control rate (DCR) was 96.9%. Median PFS, and OS were not reached. Six-month PFS rate and OS rate were 78.5% and 89.9%, respectively. The most frequent Grade 3/4 treatment-related adverse event was liver dysfunction (18.8%). Table: 60P

Baseline characteristic, response, AEs
Median age (range), y 63(41−76)
Male/Female 20/12
iCCA/pCCA/GBC 11/17/4
CR/PR/SD/PD 1/26/4/1
ORR/DCR, % 81.3/96.9
6-m PFS (95% CI), % 78.5 (58.1−89.7)
6-m OS (95% CI), % 89.9 (71.9−95.7)
Grade 3/4 AEs, n (%) 10(31.3)

Conclusions

These promising results may contribute to a paradigm shift in the first-line treatment for advanced BTC patients. Follow up for survival is ongoing.

Clinical trial identification

NCT04217954.

Editorial acknowledgement

Legal entity responsible for the study

Xiaodong Wang.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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