The study aims to compare durvalumab to chemotherapy after surgery. This trial is currently recruiting patients in China, and the estimated study completion date is January There are no available clinical data regarding pembrolizumab and durvalumab among Chinese patients. The phase I trials were launched in August and December and aim to assess the safety, tolerability, pharmacokinetics, and efficacy of these agents among Chinese patients.
The durvalumab study evaluates the combination of durvalumab plus tremelimumab for patients with advanced malignancies. Significant efforts by the Chinese government during the last 2 years have led to improvements in the overall clinical research environment [ 14 ]. The agents on the left were approved by the Chinese Food and Drug Administration for clinical trials, and the agents on the right have applied for clinical trial approval.
The CTR trial is estimated to enroll 32—51 Chinese patients with advanced solid tumors e. The CTR trial is investigating a combination of SHR and apatinib, which is a first-generation oral anti-angiogenesis drug. The main objective of the phase II study is to evaluate the safety and tolerability of this combination, and a phase III trial is planned.
Both trials are currently recruiting patients in China and enrolled their first patients on April 6, , and March 21, , respectively. The primary endpoint is PFS. Both trials have not started recruiting patients in China. The CTR trial is a phase I, single-arm, non-randomized study that aims to evaluate the safety, tolerability, and antitumor activity of the drug among Chinese patients with advanced or recurrent malignant tumors.
This clinical trial is currently recruiting patients in China. Preclinical data suggest that the drug provides good anti-tumor efficacy, and the CTR trial is a phase I study that is evaluating the safety, tolerability, and antitumor activity of IBI alone or in combination with chemotherapy among Chinese patients with malignant tumors e. The primary outcome is the therapeutic efficacy of the two IBIcontaining regimens, based on the immune-related Response Evaluation Criteria.
The study also aims to identify potential prognostic biomarkers using tumor tissues from patients who experienced a curative effect. This clinical trial is currently recruiting patients in China and enrolled its first patient on October 24, At the meeting of the American Society of Clinical Oncology, BeiGene reported preliminary clinical data from an Australian phase I study of patients with 26 different types of tumors although the tumors did not include lung cancer or melanoma.
The CTR trial is a phase I study that aims to assess the safety, tolerability, pharmacokinetics, and antitumor activity of BGB-A among Chinese patients with advanced solid tumors, such as lung carcinoma, hepatic carcinoma, and gastric carcinoma. This clinical trial has started recruiting patients in China Table 2. Immunotherapy using PD-1 or PD-L1 inhibitors provides durable clinical regression, good tolerance, and relatively few adverse events among patients with malignant tumors.
However, Chinese patients have limited access to these promising immune-checkpoint inhibitors, such as antibodies to PD-1 and PD-L1. Furthermore, the ongoing international and domestic clinical trials have duplicated the designs of previous trials for PD-1 and PD-L1 antibodies, which have revealed promising results, but rarely consider the characteristics of the Chinese or Asian populations. The characteristics of Chinese patients are important considerations in trial designs, as the Chinese population has relatively high rates of hepatitis B virus infection and traditional medicine use [ 16 ].
Furthermore, Chinese and international researchers have revealed that Chinese patients with NSCLC may have more driver gene mutations, different gene profiles, better clinical responses to chemotherapy, and different toxicity profiles [ 17 — 20 ]. However, the relevance of these characteristics remains unclear for immunotherapy with blockade of the PD-1 pathway, and data from Chinese patients remain scarce.
Second, the introduction of four FDA-approved immunohistochemistry biomarker assays, and the development of domestic reagents, may allow for the development of PD-1 immunohistochemistry assays in China. First, the relationships between PD-L1 expression and other factors e. Third, it is possible that combining immunotherapy with chemotherapy, targeted therapy, and radiotherapy could provide superior results, compared to immunotherapy alone. Fourth, although we have known that antibodies to PD-L1 have relatively low pulmonary toxicity, it remains unclear whether antibodies to PD-1 or PD-L1 provide a better clinical response.
Fifth, the conventional Response Evaluation Criteria In Solid Tumors are not appropriate for evaluating PFS after immunotherapy and pseudo-progression, and additional research is needed to improve the utility of immune-related response criteria [ 26 ]. Chinese clinical trials using PD-1 or PD-L1 inhibitors remain in their early stages, and further efforts are needed to improve the design of future clinical trials. In addition, China must take steps to help translate the results of clinical trials into clinical practice.
For example, it will be useful to simplify phase I study designs and speed up late-stage clinical development. YL designed the outline of the manuscript. SY and YL drafted the manuscript and designed and finalized the figures and tables. Both authors read and approved the final manuscript.
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Si-Yang Liu, Email: moc. Yi-Long Wu, Email: nc. National Center for Biotechnology Information , U. Journal List J Hematol Oncol v. J Hematol Oncol. Published online Jul 5. Author information Article notes Copyright and License information Disclaimer. Corresponding author. Received Apr 7; Accepted Jun This article has been cited by other articles in PMC.
Associated Data Data Availability Statement All data generated or analyzed during this study are included in this published article.
There was a significant increase in trials conducted exclusively outside of the United States The number of studies with locations in China 61, Studies reporting biomarker analysis increased significantly from Biomarker-based patient selection also increased significantly from 7.
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