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A Multicenter, Open-label, Dual-cohort Phase II Exploratory Clinical Study of Hyperthermia Combined with Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies with Liver Metastases

A Multicenter, Open-label, Dual-cohort Phase II Exploratory Clinical Study of Hyperthermia Combined with Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies with Liver Metastases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106629
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-08-08
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastrointestinal Malignancies with Liver Metastases

Interventions

Cohort1: gastric cancer group:microwave hyperthermia
Cohort2: colorectal cancer group:microwave hyperthermia

Sponsors

The First Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 75 years, male or female; 2. Histologically or cytologically confirmed diagnosis of gastrointestinal malignancy with liver metastases; 3. Prior treatment requirements: - Gastric cancer patients must have received at least one prior line of systemic therapy. - Colorectal cancer patients must have received at least two prior lines of systemic therapy. 4. Clinically assessed as suitable for hyperthermia combined with immune checkpoint inhibitor therapy; 5. At least one measurable lesion meeting RECIST 1.1 criteria; 6. Expected survival >=6 months; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 8. Adequate organ and bone marrow function; 9. Willingness to provide sufficient baseline and post-treatment samples, ability to comply with long-term follow-up and evaluation, and signed informed consent. 10. No prior history of other malignancies;

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Any comorbidities or underlying medical conditions that, in the investigator's judgment, render the patient unsuitable for study participation; 3. Presence of other severe physical or psychiatric disorders, or clinically significant laboratory abnormalities that may increase the risk associated with study participation, interfere with study results interpretation, or otherwise make the patient inappropriate for inclusion as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progression Free Survival;Disease Control Rate;Overall Survival;

Countries

China

Contacts

Public ContactXiujuan Qu

The First Hospital of China Medical University

xjqu@cmu.edu.cn+86 136 0403 1355

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026