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Clinical Trial
. 2021 Sep 28;10(1):1971418.
doi: 10.1080/2162402X.2021.1971418. eCollection 2021.

Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study

Wencheng Zhang  1 , Cihui Yan  2 , Tian Zhang  1 , Xi Chen  1 , Jie Dong  3 , Jingjing Zhao  1 , Dong Han  1 , Jun Wang  4 , Gang Zhao  5 , Fuliang Cao  6 , Dejun Zhou  6 , Hongjing Jiang  7 , Peng Tang  7 , Lujun Zhao  1 , Zhiyong Yuan  1 , Quanren Wang  8 , Ping Wang  1 , Qingsong Pang  1
Affiliations
Clinical Trial

Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study

Wencheng Zhang et al. Oncoimmunology. .

Abstract

Patients with locally advanced esophageal squamous cell carcinoma (ESCC) show poor survival after concurrent chemoradiotherapy. This study investigated the safety and feasibility of combining concurrent chemoradiotherapy with the anti-PD-1 antibody camrelizumab as first-line treatment for these patients. In this phase 1b study (ClinicalTrials.gov NCT03671265), patients received concurrent chemotherapy (cisplatin [25 mg/m2] plus docetaxel [25 mg/m2] for 4 weeks) and radiotherapy (2.0 Gy/fraction, total 60 Gy) with camrelizumab (200 mg every 2 weeks for 32 weeks). Primary endpoints were safety and tolerability, and health-related quality of life. Secondary endpoints were radiological and pathological response rates, overall survival (OS), and progression-free survival (PFS). Candidate biomarkers in tumor and peripheral blood were monitored at baseline and after 40 Gy radiation. Twenty patients were enrolled. The most common treatment-related grade 3 adverse events included radiation esophagitis (20%) and esophageal fistula (10%). Serious treatment-related adverse events occurred in eight (40%) patients. No treatment-related deaths were reported. Health-related quality of life did not deteriorate. Thirteen (65%) patients had an objective response after 40 Gy radiation. At a median follow-up of 23.7 months (95% CI 21.9-24.5), OS and PFS time ranged from 8.2-28.5 and 4.0-28.5 months, respectively. The 12-month and 24-month OS rate was 85.0% and 69.6%; PFS rate was 80.0% and 65.0%. Tumor PD-L1 expression and CD11c+ dendritic cells and peripheral-blood IL-27, IL-15, Eotaxin-3, and IL-22 were associated with OS. First-line concurrent chemoradiotherapy plus camrelizumab had a manageable safety profile and promising antitumour efficacy for ESCC, and deserves further study.

Keywords: Esophageal squamous cell carcinoma; PD-1; camrelizumab; chemoradiotherapy; immunotherapy; radiotherapy.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Duration of response and survival
Figure 2.
Figure 2.
Changes from baseline in EORTC QLQ-C30 and QLQ-OES18
Figure 3.
Figure 3.
Tumor biomarkers associated with survival
Figure 4.
Figure 4.
Gene amplification and peripheral cytokines associated with survival
See this image and copyright information in PMC

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