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2019 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A

A phase II study of anti–PD-1 antibody camrelizumab plus FOLFOX4 or GEMOX systemic chemotherapy as first-line therapy for advanced hepatocellular carcinoma or biliary tract cancer.

Hepatobiliary Cancer

Gastrointestinal (Noncolorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #179)

J Clin Oncol 37, 2019 (suppl; abstr 4074)

Author(s): Shukui Qin, Zhendong Chen, Ying Liu, Jianping Xiong, Zhenggang Ren, Zhiqiang Meng, ShanZhi Gu, Linna Wang, Jianjun Zou; Jinling Hospital, Nanjing, China; Department of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China; Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, China; Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China; Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai, China; Department of Traditional Chinese Medicine, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Interventional Radiology, Hunan Cancer Hospital, Changsha, China; Jiangsu Hengrui Medicine Co. Ltd, Shanghai, China

Abstract Disclosures


Background: Advanced hepatocellular carcinoma (HCC) and biliary tract cancer (BTC) patients (pts) have very limited treatment options. Considering the immunogenic effects of oxaliplatin, combination of camrelizumab with oxaliplatin-based chemotherapy might bring a better clinical benefit. Methods: That was an ongoing single-arm, multicenter phase 2 trial. Advanced HCC or BTC pts naive to systemic treatment were given camrelizumab (3 mg/kg i.v., every 2 weeks) plus typical FOLFOX4 (infusional fluorouracil, leucovorin and oxaliplatin) or GEMOX (gemcitabine and oxaliplatin) regimen. Primary endpoints were confirmed objective response rate (ORR) per RECIST v1.1 and safety per CTC AE 4.03. Results: From Apr 27, 2017 to Oct 31, 2018, 34 Chinese HCC and 47 BTC pts were treated, in which 27 (79.4%) HCC and 17 (36.2%) BTC pts were HBV-infected. In the 34 evaluable HCC pts, confirmed ORR was 26.5% and disease control rate (DCR) was 79.4%. Median time to response (TTR) was 2.0 mo (range 1.5–5.7). Six of the 9 responses were still ongoing, and median duration of response (DoR) was not reached (range 3.3–11.5+ mo). Median progression-free survival (PFS) was 5.5 mo. At data cutoff, 61.7% BTC pts were still receiving study drug. In the 43 evaluable BTC pts, with a median duration of exposure of 2.9 mo, confirmed ORR was 7.0% and DCR was 67.4%. Median TTR was 1.9 mo (range 1.8–2.1). Median DoR was 5.3 mo (range 3.7–7.0). Median PFS was not reached yet. Median estimates for overall survival in both HCC and BTC were also not reached. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 85.3% of HCC and 57.4% of BTC pts, most commonly neutrophil count decreased (HCC: 55.9%; BTC: 29.8%), white blood cell decreased (HCC: 38.2%; BTC: 21.3%), platelet count decreased (HCC: 17.6%; BTC: 12.8%), and anaphylaxis (BTC: 19.1%). Only one BTC pt stopped treatment due to a TRAE (recurrent Grade 2 anemia related to FOLFOX4). Grade ≥3 immune-related AEs occurred only in 5.9% of HCC (lipase increased) and 3.8% of BTC pts (anaphylaxis). Conclusions: Camrelizumab plus FOLFOX4 or GEMOX chemotherapy was tolerable and might offer a new promising choice for advanced HCC and BTC pts. Clinical trial information: NCT03092895

Other Abstracts in this Sub-Category:


1. A multicenter randomized controlled trial to evaluate the efficacy of surgery vs. radiofrequency ablation for small hepatocellular carcinoma (SURF trial).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4002 First Author: Namiki Izumi
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


2. ABC-06 | A randomised phase III, multi-centre, open-label study of Active Symptom Control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4003 First Author: Angela Lamarca
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


3. Nivolumab (NIVO) + ipilimumab (IPI) combination therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC): Results from CheckMate 040.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4012 First Author: Thomas Yau
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer