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Advances in Radiotherapy
& Nuclear Medicine PRaG therapy for renal pelvis carcinoma

colorectal cancer cell line, reached its peak on the 3 day our study titled “A prospective, multicenter, single-arm
rd
following radiotherapy, and the PD-1 expression of T clinical trial of PD-1 inhibitors in combination with
cells initially increased on the 1 day after radiotherapy radiotherapy and GM-CSF, sequentially followed by IL-2
st
and subsequently declined by the 7 day . In the (PRaG 2.0) therapy in advanced refractory solid tumors”
[16]
th
PEMBRO-RT study, the preliminary synergistic efficacy have been selected for presentation at the 2022 ASCO
of a combination PD-1 inhibitor with stereotactic body annual meeting.
radiation therapy (SBRT) was observed, in which PD-1
inhibitor was administrated within 1 week after SBRT . 4. Conclusion
[17]
Hence, we considered that, administering PD-1 inhibitor To our knowledge, it was the first time to combine
within 1 week after radiotherapy might be a suitable time. radiotherapy with anti-PD-1 therapy, GM-CSF, and
GM-CSF, a cytokine traditionally used to stimulate IL-2, which showed a significant reduction in irradiated
the production of leukocytes through simultaneous and unirradiated lesions in this case who failed previous
administration with radiotherapy for tumors, has been chemotherapy and anti-PD-1 treatment. The efficacy and
discovered to have the ability to augment the effectiveness safety of this treatment pattern and its potential effects
of immunotherapy. It facilitates the proliferation of on peripheral lymphocytes need to be further analyzed
dendritic cells (DCs) and promotes antigen presentation. and confirmed in the open-label prospective study
In a Phase II study, the combination of GM-CSF and (NCT04892498).
PD-1 inhibitor demonstrated short-term efficacy in the
treatment of advanced biliary cancer, which was reported Acknowledgments
in the American Society of Clinical Oncology (ASCO) The authors acknowledge the patient and her family for
2018. A PR was observed in 5 out of 24 patients (21%). The consenting to publish this case report.
analysis of overall survival (OS) and correlative analyses
are currently underway . Funding
[18]
The abovementioned research indicates that the This study was supported by the National Natural
combination of the PD-1 inhibitor, radiotherapy, Science Foundation of China (82171828), the Key R&D
and GM-CSF exhibit synergistic effects individually. Programme of Jiangsu Province (Social Development,
Consequently, it is plausible that a triple-combination BE2021652), Suzhou Radiotherapy Clinical Medical
of these treatments may lead to even greater efficacy Center (Szlcyxzx202103), Open Project of the State
in treating certain types of cancer. However, further Key Laboratory of Radiology and Radiation Protection
research is deemed necessary to investigate the safety of Soochow University (GZK1202014), Open Project
and effectiveness of such a combination, and it should be of Provincial Key Laboratory of Soochow University
evaluated on a case-by-case basis. (KJS1961), the Subject construction support project of
the Second Affiliated Hospital of Soochow University
Hence, our group conducted a clinical trial (PRaG (XKTJ-RC202001, XKTJHRC20210011), the Suzhou
1.0) in 2019, registered under the identifier ChiCTR Science and Technology Development Plan (SYS2020143),
1900020175, to explore the effectiveness of a combination Chinese Society of Clinical Oncology Research Foundation
therapy incorporating PD-1 inhibitors, radiotherapy, of Beijing (Y-XD202002/ZB-0015), Wu Jieping Medical
and GM-CSF for refractory metastatic solid tumors, Foundation (320.6750.2021-01-12), and the special project
with the aim of improving immunotherapy outcomes. of “Technological Innovation” project of CNNC Medical
In 2020, our research group discovered that the PRaG Industry Co. Ltd (ZHYLTD2021001), Suzhou Science and
1.0 regimen exhibited efficacy in treating metastatic Education Health Project (KJXW2021018), Postgraduate
esophageal squamous cell carcinoma that was refractory to Research & Practice Innovation Program of Jiangsu
[19]
chemotherapy and lacked PD-L1 expression .
Province (SJCX22_1508), the Suzhou Key Laboratory
Notably, our prior PRaG 1.0 trial revealed a potential for Combined Radiotherapy and Immunotherapy of
correlation between the efficacy of the treatment and Cancer (SZS2020309), Suzhou Clinical Key Diseases
the quantity of T-cells present. Interleukin-2 is an Diagnosis and Treatment Technology Special Project
immunostimulatory cytokine essential for the proliferation, (LCZX201808), Csco fund (Y-pierrefabre202102-0113),
differentiation, and survival of T cells [20,21] . Hence, we added the 2021 “Nuclear Medicine Technology Innovation”
IL-2 sequentially after GM-CSF as a part of the treatment Project of CNNC Medical (ZHYLTD2021001), Research
protocol in the PRaG 2.0 study, which is currently being project of China Baoyuan Investment Co., Ltd. (270004),
evaluated in a clinical trial (NCT04892498). It gives us the project of State Key Laboratory of Radiation Medicine
immense pleasure to announce that the outcomes from and Protection, Soochow University (No. GZK1202240),

Volume 1 Issue 1 (2023) 5 https://doi.org/10.36922/arnm.0441