Cited by 501Cancer Immunotherapy and BiomarkersHepatocellular Carcinoma Treatment and PrognosisColorectal Cancer Treatments and Studies

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Anti-PD-1 Antibody SHR-1210 Combined with Apatinib for Advanced Hepatocellular Carcinoma, Gastric, or Esophagogastric Junction Cancer: An Open-label, Dose Escalation and Expansion Study

Xu, Jianming, Zhang, Yun, Jia, Ru, Yue, Chunyan, Chang, Lianpeng, Liu, Rongrui, Zhang, Gairong, Zhao, Chuanhua, Zhang, Yaoyue, Chen, Chunxia, Wang, Yan, Yi, Xin, Hu, Zhiyuan, Zou, Jianjun, Wang, Quanren·2019·Clinical Cancer Research

DOI 10.1158/1078-0432.ccr-18-2484

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Abstract

Purpose: This study assessed the safety and efficacy of SHR-1210 (anti-PD-1 antibody) and apatinib (VEGFR2 inhibitor) as combination therapy in patients with advanced hepatocellular carcinoma (HCC), gastric, or esophagogastric junction cancer (GC/EGJC). Patients and Methods: This was an open-label, dose-escalation (phase Ia) and expansion study (phase Ib). In phase Ia, patients (n = 15) received SHR-1210 200 mg every 2 weeks and apatinib 125–500 mg once daily until unacceptable toxicity or disease progression. In phase Ib, patients (n = 28) received apatinib at the phase Ia–identified recommended phase II dose (RP2D) plus SHR-1210. The primary objectives were safety and tolerability and RP2D determination. Results: At data cutoff, 43 patients were enrolled. In phase Ia, four dose-limiting toxicity events were observed (26.7%): one grade 3 lipase elevation (6.7%) in the apatinib 250 mg cohort and three grade 3 pneumonitis events (20%) in the apatinib 500 mg cohort. The maximum tolerated RP2D for apatinib was 250 mg. Of the 33 patients treated with the R2PD combination, 20 (60.6%) experienced a grade ≥3 treatment-related adverse event; adverse events in ≥10% of patients were hypertension (15.2%) and increased aspartate aminotransferase (15.2%). The objective response rate in 39 evaluable patients was 30.8% (95% CI: 17.0%–47.6%). Eight of 16 evaluable HCC patients achieved a partial response (50.0%, 95% CI: 24.7%–75.4%). Conclusions: SHR-1210 and apatinib combination therapy demonstrated manageable toxicity in patients with HCC and GC/EGJC at recommended single-agent doses of both drugs. The RP2D for apatinib as combination therapy was 250 mg, which showed encouraging clinical activity in patients with advanced HCC.

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Authors: Xu, J., Zhang, Y., Jia, R., Yue, C., Chang, L., Liu, R., Zhang, G., Zhao, C., Zhang, Y., Chen, C., Wang, Y., Yi, X., Hu, Z., Zou, J., & Wang, Q.
Affiliations: 1Department of Gastrointestinal Oncology, Affiliated Hospital Cancer Center, Academy of Military Medical Sciences, Beijing, China.
Academy of Military Medical Sciences (CN)
Chinese Academy of Sciences (CN)
3Geneplus-Beijing Institute, Beijing, China.
Jiangsu Hengrui Medicine (China) (CN)
ORCID: Jia, Ru
Yue, Chunyan
Chang, Lianpeng
Liu, Rongrui
Wang, Yan
Yi, Xin
Hu, Zhiyuan
Zou, Jianjun
Venue: Clinical Cancer Research
Publisher: American Association for Cancer Research (AACR)
Published: 2019-01-15
Volume: 25
Issue: 2
Pages: 515-523
ISSN: 1078-0432 (ISSN-L)
1557-3265
DOI: 10.1158/1078-0432.ccr-18-2484
OpenAlex: W2897612290
Cited by: 498
References: 46
Citations by year: 2026: 19 · 2025: 33 · 2024: 67 · 2023: 69 · 2022: 109 · 2021: 91 · 2020: 82 · 2019: 26
FWCI: 18.90
Type: journal article
Language: en
Open access: closed
Locations: Clinical Cancer Research (publishedVersion)
PubMed (publishedVersion)
Funders: Jiangsu Hengrui Medicine Co. Ltd.
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Keywords: pembrolizumab, anti-PD-1, apatinib, VEGFR-2 inhibitors, combination immunotherapy, hepatocellular carcinoma, gastric cancer, gastroesophageal junction cancer, dose-limiting toxicity, pneumonitis, lipase elevation, recommended phase 2 dose, objective response rate
MeSH terms: Antineoplastic Agents, Immunological, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Esophageal Neoplasms, Esophagogastric Junction, Female, Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Male, Middle Aged, Prognosis, Pyridines, Stomach Neoplasms, Biomarkers, Treatment Outcome, Molecular Targeted Therapy, Antibodies, Monoclonal, Humanized

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Anti-PD-1 Antibody SHR-1210 Combined with Apatinib for Advanced Hepatocellular Carcinoma, Gastric, or Esophagogastric Junction Cancer: An Open-label, Dose Escalation and Expansion Study

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