Hyperthermia Combined With Immune Checkpoint Inhibitor Therapy for Advanced Gastrointestinal Tumours

The specific treatment process is shown in the trial flow diagram. The patients underwent WIRA whole-body hyperthermia on days 1 and 8 of each HIT cycle. On day 2 (24 h after hyperthermia on day 1), 200 mg of tislelizumab prepared with 100 mL of normal saline was intravenously administered for less than 30 min. After six HIT cycles, tislelizumab was administered intravenously every 21 days until drop-out. For quality control of hyperthermia, the core temperature was set to 38·5-39·5 °C and measured using a rectal temperature-sensing probe. Hyperthermia was considered to have been achieved when this temperature range was recached and maintained for 60 min. Each hyperthermia session lasted for 2 h, including a 30-min heating stage, a 60-min insulation stage, and a 30-min cooling stage. Clinical data were collected every two HIT treatment cycles and evaluated using the RECIST version 1.1 standard.

Inclusion criteria

• Patients with advanced GIT who have previously received third-line or above treatment.
• Patients are aged 18-75.
• Patients with at least one measurable tumor lesion.
• Patients' all physiological indexes meet the HIT requirements.

Exclusion criteria

• Patients have participated in other clinical trials within 4 weeks before enrollment.
• Patients contraindicate to whole-body hyperthermia.
• Patients contraindicate to immunotherapy.
• Patients cannot fully cooperate with HIT and follow-up.
• Pregnant or lactating women.
• Other circumstances may affect the results.