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Heating up tumors: could thermal therapy boost immune attack on breast cancer?

NCT ID NCT06636591

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This pilot study tests whether adding a special heat therapy (multimodal thermal therapy) to standard chemotherapy and immunotherapy can help the immune system better recognize and attack HER2-negative breast cancer. The study enrolls women aged 18–70 with certain subtypes of breast cancer who have not yet had surgery. Researchers will measure immune cell activity in blood and tumor tissue to see if the combination triggers a stronger immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Camrelizumab, Nab paclitaxel, Carboplatin, Goserelin, Multimodal Tumor Thermal Therapy System
What this could lead to
If successful, this approach could improve immune activation against breast cancer, potentially leading to better outcomes before surgery.
What could go wrong
This is a very small pilot study (14 people) with no control group, so results may not be generalizable. The combination therapy may cause side effects without clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Dec 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female，age 18-70 years. 2. Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria; 3. TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC); 4. At least one measurable lesion according to RECIST 1.1 criteria; 5. Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 6. LVEF ≥55%; 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 8. Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug; 9. Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: 1. Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; 2. Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II); 3. Patients with severe systemic infections or other serious diseases; 4. Patients with known allergy or intolerance to the study drug or its excipients; 5. Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 6. Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study; 7. Participated in other trial studies within 30 days before the administration of the first dose of the study drug; 8. Endocrine system disorders; 9. Patients who were judged by the investigator to be unsuitable for this study.

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Conditions

The condition(s) this trial relates to.

female breast carcinoma Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer female HER2-negative breast cancer

Contacts and locations

Locations

  • Breast cancer institute of Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032, China

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