Yu Yang, Yu Rong, Wang Na, Bai Yuping, Shi Qianling, Maswikiti Ewetse Paul, Chen Hao
The Department of Tumor Surgery, Lanzhou University Second Hospital, Lanzhou, China.
The Second Clinical Medical College, Lanzhou University, Lanzhou, China.
Front Pharmacol. 2023 Jan 26;14:1063775. doi: 10.3389/fphar.2023.1063775. eCollection 2023.
The immune checkpoint inhibitor (ICI) has been approved as the first-line therapy for metastatic gastric cancer in China. The treatment response of immune checkpoint inhibitor is highly dependent on the immune condition within the tumor microenvironment. Photodynamic therapy (PDT) has a long history in cancer treatment, and recent studies showed it had an immunomodulatory effect on the tumor. Here we will conduct a trial to assess whether or not a combination with Photodynamic therapy will improve the outcomes of immune checkpoint inhibitor-based treatment in patients with advanced or metastatic gastric cancer. This study is a single-center, open-label, randomized controlled, phase 2-3 trial. Patients (18-65 years old) with untreated gastric or gastroesophageal junction adenocarcinoma will be eligible for this trial. Sixty participants will be enrolled and randomly divided into the test group ( = 30) and control group ( = 30) to receive photodynamic therapy in combination with immune checkpoint inhibitor plus chemotherapy and immune checkpoint inhibitor plus chemotherapy, respectively. The primary is progression-free survival (PFS). The secondary outcomes include objective response rates (ORRs) and the occurrence of adverse events. In addition, we will also assess the changes in peripheral blood mononuclear cells (PBMCs) and tumor microenvironment after photodynamic therapy treatment in the test group. Evaluation of the tumor response will be performed every two cycles for a maximum of eight cycles. Photodynamic therapy has an immunomodulatory effect on the tumor microenvironment; however, this has not been demonstrated for gastric cancer in a clinical trial. Based on our experience of photodynamic therapy treatment in digestive tract tumors, we plan to conduct a randomized controlled trial on this topic. This will be the first study to evaluate the synergistic effect of photodynamic therapy with immunochemotherapy for patients with advanced gastric cancer. It was approved by the Institutional Research Ethics Committee of Lanzhou University Second Hospital (No. 2022A-491). When this trial is completed, it will be shared at conferences and submitted for a potential publication in a peer-reviewed journal. http://www.chictr.org.cn/, identifier ChiCTR2200064280.
免疫检查点抑制剂（ICI）已在中国获批成为转移性胃癌的一线治疗方案。免疫检查点抑制剂的治疗反应高度依赖于肿瘤微环境中的免疫状态。光动力疗法（PDT）在癌症治疗领域有着悠久的历史，近期研究表明其对肿瘤具有免疫调节作用。在此，我们将开展一项试验，以评估光动力疗法联合治疗是否能改善晚期或转移性胃癌患者基于免疫检查点抑制剂的治疗效果。本研究为单中心、开放标签、随机对照的2期至3期试验。未接受过治疗的胃或胃食管交界腺癌患者（年龄在18至65岁之间）符合本试验条件。将招募60名参与者并随机分为试验组（n = 30）和对照组（n = 30），分别接受光动力疗法联合免疫检查点抑制剂加化疗以及免疫检查点抑制剂加化疗。主要终点是无进展生存期（PFS）。次要终点包括客观缓解率（ORR）和不良事件的发生情况。此外，我们还将评估试验组光动力疗法治疗后外周血单个核细胞（PBMC）和肿瘤微环境中的变化。每两个周期进行一次肿瘤反应评估，最多评估八个周期。光动力疗法对肿瘤微环境具有免疫调节作用；然而，在胃癌的临床试验中尚未得到证实。基于我们在消化道肿瘤光动力疗法治疗方面的经验，我们计划针对此主题开展一项随机对照试验。这将是第一项评估光动力疗法与免疫化疗联合治疗晚期胃癌患者协同效应的研究。本研究已获得兰州大学第二医院机构研究伦理委员会批准（批准号：2022A - 491）。本试验完成后，将在会议上进行分享，并提交至同行评审期刊发表。http://www.chictr.org.cn/，标识符ChiCTR2200064280
