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ePoster Display

949P - Thermal ablation plus toripalimab in patients with advanced hepatocellular carcinoma: Phase I results from a multicenter, open-label, controlled phase I/II trial (IR11330)

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Site

Hepatobiliary Cancers

Presenters

Liangrong Shi

Citation

Annals of Oncology (2021) 32 (suppl_5): S818-S828. 10.1016/annonc/annonc677

Authors

L. Shi1, C. Zhou1, X. Long2, H. Li1, C. Chen1, C. Peng1, P. Li3, J. Li4, S. Gu5, B. Liang6, W. Liao7

Author affiliations

  • 1 Interventional Radiology Department, Xiangya Hospital of Central South University, 410005 - Changsha/CN
  • 2 Radiology Department, Xiangya Hospital of Central South University, 410005 - Changsha/CN
  • 3 Department Of Radiology, The First Affiliated Hospital, Hunan University of traditional Chinese Medicine, 410208 - Changsha/CN
  • 4 Department Of Interventional Oncology, the First Affiliated Hospital, Sun Yat-Sen University, 510080 - Guangzhou/CN
  • 5 Department Of Interventional Radiology, Hunan Cancer Hospital, 410013 - Changsha/CN
  • 6 Department Of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 430022 - Wuhan/CN
  • 7 Department Of Radiology, Xiangya Hospital of Central South University, 410005 - Changsha/CN
More

Abstract 949P

Background

Thermal ablation has been showed to induce immunogenic cell death and enhance the effect of anti-programmed death-1 (PD-1) in preclinical study. The open label phase I/II trial evaluated the safety and efficacy of ablation plus toripalimab (a humanized PD-1 antibody) in patients with advanced hepatocellular carcinoma (HCC). Phase I results on time scheduling, safety and preliminary antitumor activity are reported.

Methods

Patients who had advanced HCC after failure of a least one-line systemic therapy were included and randomized into 3 arms. In arm A, patients received toripalimab (240mg, Q3W) as monotherapy. In arm B, patients received subtotal ablation, defined as complete treatment of 1-5 lesions by thermal ablation and leave others lesions intact. Toripalimab (240mg, Q3W) was started on day 3 after ablation. In arm C, patients received toripalimab (240mg, Q3W) on day 14 after ablation.

Results

Forty-eight patients (16 per arm) were included. Seventy five percent of patients experienced treatment-related adverse events (TRAE). The most common TREAs were mild (grade 1/2) and include influenza-like symptoms (25%), AST and/or ALT elevation (22.9%), hypothyroidism (22.9%), hypertension (16.6%), diarrhea (14.6%) and proteinuria (12.5%). Grade 3/4 TRAEs was reported in 18.7% of patients in arm A, 25.0% in arm B and C, respectively. One patient in arm A (6.3%) and one in arm B discontinued toripalimab treatment because of TRAE. No TRAE led to death. By the cutoff date, the objective response rate (ORR) was 18.8% in arm A, 37.5% in arm B and 31.2% in arm C. In arm B, 2 patients (12.5%) achieved complete response (CR). Initiating toripalimab treatment on day 3 after ablation was recommended for phase II evaluation.

Conclusions

The combination of subtotal thermal ablation and toripalimab was tolerable and showed promising antitumor activity in advanced HCC, especially with optimal schedule.

Clinical trial identification

NCT03864211.

Editorial acknowledgement

Legal entity responsible for the study

Xiangya Hospital, Central South University.

Funding

TopAlliance Biosciences Inc.

Disclosure

All authors have declared no conflicts of interest.

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