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Proffered paper session - Gastrointestinal tumours, non colorectal

792 - A Randomized Multicentered Phase 2 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects with Advanced Hepatocellular Carcinoma (HCC) who Failed or Intolerable to Prior Systemic Treatment


21 Oct 2018


Proffered paper session - Gastrointestinal tumours, non colorectal


Clinical Research;  Immunotherapy

Tumour Site

Hepatobiliary Cancers


Shu Qin


S.K. Qin1, Z.G. Ren2, Z.Q. Meng3, Z.D. Chen4, X.L. Chai5, J.P. Xiong6, Y.X. Bai7, L. Yang8, H. Zhu9, W.J. Fang10, X.Y. Lin11, X.M. Chen12, E.X. Li13, Y. Xia14, J.J. Zou14

Author affiliations

  • 1 Cancer Center Of Bayi Hospital, Nanjing Chinese Medicine University Oncology, 210002 - Nanjing/CN
  • 2 Medical Oncology Dept., Zhongshan Hospital, Fudan University, Shanghai/CN
  • 3 Traditional Chinese Medicine Dpt., Fudan University Shanghai Cancer Center, shanghai/CN
  • 4 Medical Oncology Dept., 2nd Hospital of Anhui Medical University, 230601 - Hefei/CN
  • 5 Radiology Interventional Dpt., Hunan Cancer Hospital, Changsha/CN
  • 6 Medical Oncology Dept., The First Affiliated Of Nanchang University, Nanchang/CN
  • 7 Medical Oncology Dept., 3rd Affiliated Hospital of Harbin Medical University, 150081 - Harbin/CN
  • 8 Department Of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 100021 - Beijing/CN
  • 9 Medical Oncology Dept., West China Hospital, Chengdu/CN
  • 10 Medical Oncology Dept., 1st Affiliated Hospital of Zhejiang University School of Medicine, 310003 - Hangzhou/CN
  • 11 Medical Oncology Dept., Fujian Medical University Union Hospital, Fuzhou/CN
  • 12 Radiology Interventional Dept., Guangdong General Hospital, Guangzhou/CN
  • 13 Medical Oncology Dept., First Affiliated Hospital of Xi'an Jiaotong University (School of Medicine), 710061 - Xi'an/CN
  • 14 Clinical research & Development-oncology, Jiangsu Hengrui Medicine Co. LTD, 200122 - Shanghai/CN


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Abstract 792


PD-1 antibodies have brought promising benefit to advanced hepatocellular carcinoma (HCC) patients (pts) who had been treated with sorafenib etc. Camrelizumab (SHR-1210), a fully humanized anti–PD-1 IgG4 monoclonal antibody, was well tolerated with promising antitumor activity observed in phase 1 trials.


In this phase 2 trial, HCC pts who progressed on or were intolerant to at least one line of prior systemic therapies were randomized (1:1) to camrelizumab 3 mg/kg iv.gtt for q2w or q3w group. The primary endpoints were confirmed objective response rate (ORR) by blinded independent central review according to RECIST v1.1 criteria and 6-month (6-mo) overall survival (OS) rate.


From 15 Nov. 2016 to 16 Nov. 2017, 220 pts at Chinese national-wide 13 sites were randomized and 217 were treated (109 in q2w and 108 in q3w group). As of 16 May 2018, the ORR was 13.8% (95% CI 9.5–19.1) and 6-mo OS rate was 74.7% (95% CI 68.3–79.9). Median time to response was 2.0 mo (range 1.7–6.2). Of the 30 responses, 22 were ongoing, and median duration of response was not reached (range 2.5–15.4+ mo). Disease control rate was 44.7% (95% CI 38.0–51.6). Median time to progression was 2.6 mo (95% CI 2.0–3.3) and median progression-free survival was 2.1 mo (95% CI 2.0–3.2). Median OS was not reached. The most common treatment related adverse events (TRAEs, ≥20.0%) were reactive cutaneous capillary endothelial proliferation (RCEP, 66.8%, all in grade ≤2), increased AST (24.4%), increased ALT (23.0%) and proteinuria (23.0%). Exploratory analysis indicated that pts experienced RCEP had significantly higher ORR (18.9% vs. 5.8%, P=0.0022). Pts in the q2w or q3w group had comparable efficacy and TRAEs incidence (Table). The prior sorafenib-exposed only pts seemed to have superior outcomes (Table).

Table: Efficacy and safety data in all subjects and different study subpopulation
All subjects Subjects received prior sorafenib* Subjects received sorafenib only before enrollment#
Total q2w group q3w group
n 217 109 108 157 117
Primary endpoints
ORR, n (%; 95% CI) 30 (13.8%; 9.5–19.1) 12 (11.0%; 5.8–18.4) 18 (16.7%; 10.2–25.1) 25 (15.9%; 10.6–22.6) 21 (17.9%; 11.5–26.1)
6-mo OS, % (95% CI) 74.7 (68.3–79.9) 76.1 (67.0–83.1) 73.1 (63.7–80.5) 75.8 (68.3–81.8) 76.9 (68.2–83.5)
TRAEs, n (%)
All grades 197 (90.8) 99 (90.8) 98 (90.7) 143 (91.1) 108 (92.3)
Grade ≥3 42 (19.4) 21 (19.3) 21 (19.4) 33 (21.0) 28 (23.9)
Serious 21 (9.7) 14 (12.8) 7 (6.5) 15 (9.6) 9 (7.7)

* Part of subjects in this subpopulation received other systemic therapy beyond sorafenib before enrollment; # In this subpopulation, sorafenib was the only systemic therapy received before enrollment.


Camrelizumab showed high ORR, durable response and acceptable toxicities in Chinese pretreated advanced HCC pts.

Clinical trial identification

Clinical trial identification: NCT02989922

Editorial Acknowledgement


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