The DOI matches its Crossref record; 45 of the 46 references it cites were found in a registry or an index.
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
Published version of a preprint
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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“Accumulating evidence indicates that chemotherapy, radiotherapy, angiogenesis inhibitor, stimulator of interferon genes (STING) agonist, fecal microbiota transplantation (FMT), epigenetic modulators, or other immunomodulators could synergize α-PD-1/PD-L1, by enhancing cancer antigen release, APC function, or effector activity [22–31].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [22]
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“Combination therapies such as sintilimab plus anlotinib, sintilimab plus IBI305 (bevacizumab biosimilar), camrelizumab plus apatinib, and toripalimab plus axitinib demonstrated potent antitumor effects in multiple types of cancers [22, 114–120].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [22]
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Items 501–501 of 501
Metadata
- 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)
- Venue
- Clinical Cancer Research
- Published
- 2019-01-15
- Volume
- 25
- Issue
- 2
- Pages
- 515-523
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- 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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