Hyperthermia Combined With Immune Checkpoint Inhibitor Therapy for Advanced Gastrointestinal Tumours

NCT06022692 | Completed Phase 1

• 1 other identifier: ZhejiangH
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal tumours (GITs) are the most common and fatal cancers worldwide; 96% of GITs show the microsatellite-stable (MSS)/proficient mismatch repair (pMMR) phenotype, and these tumours have a poor response to immune checkpoint inhibitor (ICI) therapy. Hyperthermia combined with ICI treatment (HIT) has been reported to show a synergistic sensitisation effect in numerous basic studies. This study aimed to validate the effectiveness, safety, and feasibility of water-filtered infrared A radiation (WIRA) whole-body hyperthermia combined with PD-1 inhibitor therapy and evaluate the real-world clinical application prospects of HIT. This open-label single-arm phase 2 clinical trial aimed to enrol advanced GIT patients with the MSS/pMMR phenotype in the East Asian population who had received third-line or higher treatment. The patients were treated with whole-body hyperthermia on days 1 and 8 of each HIT cycle along with administration of tislelizumab 200 mg on day 2 (24 h after the hyperthermia at day 1). The primary outcome was the disease control rate (DCR), while the secondary outcomes were progression-free survival (PFS), overall survival (OS), safety, and improvement in quality of life.

Conditions

Gastrointestinal Tumor

Keywords

hyperthermia; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• disease control rate (DCR)

  DCR=(PR+CR) / (PD+SD+PR+CR) \* 100%

  up to 6 months

Secondary Outcomes (2)

• progression-free survival (PFS)

  up to 36 months

• overall survival (OS)

  up to 36 months

Study Arms (1)

hyperthermia combined with immune checkpoint inhibitor group

EXPERIMENTAL

The patients were treated with whole-body hyperthermia on days 1 and 8 of each HIT cycle along with administration of tislelizumab 200 mg on day 2 (24 h after the hyperthermia at day 1).

Device: Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany); Drug: tislelizumab (BeiGene, China) combined with PD-1 inhibitor

Interventions

Water-filtered infrared A radiation whole-body hyperthermia (HECKEL 3000MT-4T, Germany) DEVICE

The patients were treated with whole-body hyperthermia (HECKEL 3000MT-4T, Germany)) on days 1 and 8 of each hyperthermia combined with immune checkpoint inhibitor treatment cycle along with administration of tislelizumab (BeiGene, China) 200 mg on day 2 (24 hours after the hyperthermia at day 1).

hyperthermia combined with immune checkpoint inhibitor group

tislelizumab (BeiGene, China) combined with PD-1 inhibitor DRUG

The patients were treated with whole-body hyperthermia (HECKEL 3000MT-4T, Germany)) on days 1 and 8 of each hyperthermia combined with immune checkpoint inhibitor treatment cycle along with administration of tislelizumab (BeiGene, China) 200 mg on day 2 (24 hours after the hyperthermia at day 1).

Also known as: Immune checkpoint inhibitor, PD-1 antibody

hyperthermia combined with immune checkpoint inhibitor group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pengyuan Liu: lead
• Zhejiang Hospital: collaborator

Study Sites (1)

Zhejiang Hospital

Hangzhou, China

Location

MeSH Terms

Conditions

Digestive System Neoplasms; Hyperthermia

Interventions

tislelizumab; Immune Checkpoint Inhibitors; spartalizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Jun Chen

  Zhejiang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Secretary

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 5, 2023
• Study Start: June 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: August 1, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)