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Abstract：
This study pioneered the use of WIRA whole-body infrared hyperthermia combined with ICI therapy to treat GIT and verified the feasibility and safety of HIT. The final results showed a DCR of 55.6%, with a median PFS of 53.5 days, median OS of 134 days, and an irAE incidence of 22.2%. Therefore, we believe that HIT can exert multiple synergistic sensitisation effects, thereby providing clinical benefits to patients with advanced GITs, increasing overall safety, and improving patients\' QOL.
BACKGROUND: This study aimed to validate the effectiveness, safety and feasibility of water‐filtered infrared A radiation (WIRA) whole‐body hyperthermia combined with immune checkpoint inhibitor (ICI) therapy (HIT) and evaluate the real‐world clinical application prospects.
METHODS: This open‐label single‐arm phase 2 clinical trial (NCT06022692) aimed to enrol advanced gastrointestinal tumour (GIT) patients with the MSS/pMMR phenotype. The patients were treated with whole‐body hyperthermia on Days 1 and 8 of each HIT cycle along with administration of tislelizumab on Day 2.
RESULTS: Between 1 June 2020 and 31 May 2022, 18 patients were enrolled in the study, including those with gastric cancer (n = 6), colon cancer (n = 7), rectal cancer (n = 3) and appendiceal cancer (n = 2). As of 19 May 2023, 17 of the 18 patients had died, including 14 deaths caused by tumour progression and three deaths caused by diseases other than cancer, while one patient was still undergoing follow‐up. In terms of efficacy, the median DCR was 55.6%, while the median PFS and OS were 53.5 days and 134 days, respectively. Four patients (22.2%) experienced immune‐related adverse events, and none of the patients reported grade 3 or higher irAEs. Hyperthermia was followed by an increase in the number of tumour immune‐activated cells.
CONCLUSIONS: HIT can provide survival benefits in patients with GITs by activating antitumour immune function and shows good safety and feasibility.
BACKGROUND: This study aimed to validate the effectiveness, safety and feasibility of water‐filtered infrared A radiation (WIRA) whole‐body hyperthermia combined with immune checkpoint inhibitor (ICI) therapy (HIT) and evaluate the real‐world clinical application prospects.
METHODS: This open‐label single‐arm phase 2 clinical trial (NCT06022692) aimed to enrol advanced gastrointestinal tumour (GIT) patients with the MSS/pMMR phenotype. The patients were treated with whole‐body hyperthermia on Days 1 and 8 of each HIT cycle along with administration of tislelizumab on Day 2.
RESULTS: Between 1 June 2020 and 31 May 2022, 18 patients were enrolled in the study, including those with gastric cancer (n = 6), colon cancer (n = 7), rectal cancer (n = 3) and appendiceal cancer (n = 2). As of 19 May 2023, 17 of the 18 patients had died, including 14 deaths caused by tumour progression and three deaths caused by diseases other than cancer, while one patient was still undergoing follow‐up. In terms of efficacy, the median DCR was 55.6%, while the median PFS and OS were 53.5 days and 134 days, respectively. Four patients (22.2%) experienced immune‐related adverse events, and none of the patients reported grade 3 or higher irAEs. Hyperthermia was followed by an increase in the number of tumour immune‐activated cells.
CONCLUSIONS: HIT can provide survival benefits in patients with GITs by activating antitumour immune function and shows good safety and feasibility.
摘要：
本研究率先采用WIRA全身红外热疗法联合ICI治疗GIT,验证了HIT的可行性和安全性。最终结果显示DCR为55.6%,平均PFS为53.5天，中位OS为134天，IRAE发生率为22.2%。因此,我们认为HIT可以发挥多重协同致敏作用，从而为晚期GIT患者提供临床益处，提高整体安全性，改善患者的生活质量。
背景：本研究旨在验证有效性，水过滤红外A辐射（WIRA）全身热疗联合免疫检查点抑制剂（ICI）治疗（HIT）的安全性和可行性，并评估真实世界的临床应用前景。
方法：这项开放标签的单臂2期临床试验（NCT06022692）旨在招募具有MSS/pMMR表型的晚期胃肠道肿瘤（GIT）患者。在每个HIT周期的第1天和第8天对患者进行全身热疗，并在第2天给予tislelizumab。
结果：在2020年6月1日至2022年5月31日期间，18名患者被纳入研究，包括胃癌患者（n=6），结肠癌（n=7），直肠癌（n=3）和阑尾癌（n=2）。截至2023年5月19日，18名患者中有17人死亡，包括14人因肿瘤进展而死亡，3人因癌症以外的疾病而死亡，而一名患者仍在接受随访。就功效而言,DCR中位数为55.6%,而中位PFS和OS分别为53.5天和134天，分别。四名患者（22.2%）经历了免疫相关的不良事件，没有患者报告3级或更高的irAE。热疗后肿瘤免疫激活细胞数量增加。
结论：HIT可通过激活抗肿瘤免疫功能为GIT患者提供生存益处，具有良好的安全性和可行性。
背景：本研究旨在验证有效性，水过滤红外A辐射（WIRA）全身热疗联合免疫检查点抑制剂（ICI）治疗（HIT）的安全性和可行性，并评估真实世界的临床应用前景。
方法：这项开放标签的单臂2期临床试验（NCT06022692）旨在招募具有MSS/pMMR表型的晚期胃肠道肿瘤（GIT）患者。在每个HIT周期的第1天和第8天对患者进行全身热疗，并在第2天给予tislelizumab。
结果：在2020年6月1日至2022年5月31日期间，18名患者被纳入研究，包括胃癌患者（n=6），结肠癌（n=7），直肠癌（n=3）和阑尾癌（n=2）。截至2023年5月19日，18名患者中有17人死亡，包括14人因肿瘤进展而死亡，3人因癌症以外的疾病而死亡，而一名患者仍在接受随访。就功效而言,DCR中位数为55.6%,而中位PFS和OS分别为53.5天和134天，分别。四名患者（22.2%）经历了免疫相关的不良事件，没有患者报告3级或更高的irAE。热疗后肿瘤免疫激活细胞数量增加。
结论：HIT可通过激活抗肿瘤免疫功能为GIT患者提供生存益处，具有良好的安全性和可行性。
