Cryoablation + Immunotherapy for Cancer

Overseen By Alda L Tam

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Immunotherapy

Must not be taking: Immunosuppressants

Disqualifiers: Autoimmune disorders, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining cryoablation with immunotherapy can more effectively treat cancers that have metastasized. Cryoablation, or cryosurgery, involves freezing the tumor to kill cancer cells. The trial seeks to assess whether this addition enhances the effectiveness of standard immunotherapy. It may suit individuals with metastatic cancer who previously benefited from immunotherapy before the cancer progressed. Participants should have at least two cancerous areas that have not received specific local therapies. As an unphased trial, this study provides a unique opportunity for patients to explore innovative treatment combinations that could enhance their current care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must continue your current immunotherapy dose regimen for at least 3 months after cryoablation. If you are on immunosuppressive medication, you may need to stop, unless it's a low-dose steroid or for specific conditions like allergies.

What prior data suggests that cryoablation is safe for cancer treatment?

Research has shown that cryoablation, a treatment that freezes and destroys cancer cells, is generally safe. Studies indicate that patients tolerate it well and achieve good results in the short and medium term. For instance, one study found that patients experienced positive outcomes with few complications after cryotherapy. Furthermore, long-term research suggests that most patients do not require further aggressive treatments or experience cancer spread for many years.

Regarding the immunotherapy in this trial, these treatments effectively target cancer cells. They can sometimes cause side effects related to the immune system, but proper care usually manages these. Overall, both cryoablation and immunotherapy have safety records indicating they are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining cryoablation with immunotherapy for cancer because it offers a unique approach to enhancing the body's immune response against tumors. Cryoablation involves freezing cancer cells, which can cause them to break apart and release antigens that stimulate the immune system. This process potentially makes the immunotherapy more effective by creating a stronger and more targeted attack on the cancer cells. Unlike traditional treatments that rely solely on immunotherapy or chemotherapy, this combination aims to boost the body's natural defenses, possibly leading to more effective and faster results.

What evidence suggests that cryoablation and immunotherapy could be effective for metastatic cancer?

Research has shown that cryoablation, a method that freezes and kills cancer cells, yields promising results in cancer treatment. In prostate cancer, cryoablation has resulted in high survival rates, with up to 97% of patients not experiencing cancer spread after five years. One study found that it controls cancer in the short term for 80% to 90% of patients. In this trial, participants will undergo cryoablation, which may effectively stop cancer from spreading, especially when combined with immunotherapy. Freezing the tumor might also enhance the immune system's ability to attack cancer cells. ^{1 2 3 6 7}

Who Is on the Research Team?

Alda L. Tam

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with metastatic cancer who are on standard immunotherapy and have shown some response followed by progression. They must be able to continue their current treatment post-cryoablation, have a life expectancy over 6 months, good performance status, normal organ function tests, and at least two untreated lesions measurable by CT or MRI. Pregnant women or those with uncontrolled illnesses, certain autoimmune diseases without PI approval, prior severe immune-related drug toxicity not recovered to baseline or grade 1 (except alopecia), active infections like TB or hepatitis B/C, known allergies to contrast media agents cannot participate.

Inclusion Criteria

I am post-menopausal or not pregnant if pre-menopausal.

I previously responded to immunotherapy but my cancer has since worsened.

I have at least two cancer lesions untreated by targeted therapies, measurable by CT or MRI.

Exclusion Criteria

I have had side effects from previous immune therapy that haven't fully improved.

I have not received a live vaccine in the last 30 days.

I am not pregnant or nursing and if capable of becoming pregnant, I am using effective birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo core biopsy of the lesion to be ablated and a non-ablated lesion, followed by cryoablation. A second core biopsy of the non-ablated lesion is performed 4 weeks after cryoablation.

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after cryoablation, with follow-up lasting up to 12 months post-treatment.

12 months

Long-term follow-up

Participants are periodically monitored for progression and survival outcomes up to 2 years.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Cryosurgery
• Immunotherapeutic Agent

Trial Overview The study investigates the effectiveness of cryoablation—a technique where a probe freezes tissue around tumors—in addition to ongoing immunotherapy in treating metastatic cancer. The goal is to see if freezing the tumor cells can enhance the effects of standard immunotherapy treatments.

How Is the Trial Designed?

Group I: Treatment (cryoablation) Experimental Treatment 3 Interventions

Beginning 1 week prior to the next scheduled standard of care immunotherapy infusion, patients undergo core biopsy of the lesion to be ablated and a non-ablated lesion and also undergo cryoablation. Patients undergo a mandatory second core biopsy of the non-ablated lesion at 4 weeks after cryoablation.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cryoablation is gaining popularity as a primary treatment for localized cancers and as a salvage therapy for metastatic cancers, showing promise in inducing a systemic antitumor immune response.

To enhance the immune response triggered by cryoablation, combining it with other immunomodulatory agents could create a more effective cryoimmunotherapeutic strategy, potentially improving outcomes for patients with metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer immunotherapy using tumor cryoablation. Sidana, A.[2014]

Cryoablation is a safe and well-tolerated outpatient procedure that can treat small breast cancers and metastatic sites, especially in patients who cannot undergo surgery.

Recent studies indicate that cryoablation may enhance the immune system's ability to recognize and attack cancer cells by increasing the expression of tumor neoantigens, potentially improving the effectiveness of immunotherapy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation and Immunotherapy for Breast Cancer: Overview and Rationale for Combined Therapy. Regen-Tuero, HC., Ward, RC., Sikov, WM., et al.[2021]

Immunotherapy is becoming an effective treatment for pediatric cancers, offering a different mechanism of action compared to traditional chemotherapy, which leads to unique adverse events (AEs).

A systematic review of 17 articles identified common AEs associated with five key immunotherapy agents, emphasizing the need for nurses to understand these specific AEs to effectively monitor and manage pediatric patients undergoing immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commonly Reported Adverse Events Associated With Pediatric Immunotherapy: A Systematic Review From the Children's Oncology Group Withycombe, JS., Carlson, A., Coleman, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12227874/

Current Status of Cryoablation in Prostate Cancer ... However, the procedure provided effective cancer control, with a 5-year BCR-free survival (BCR-FS) rate of 54%. In the study by Deivasigamani et ...

2. nature.com nature.com/articles/s41391-024-00911-2

Established focal therapy—HIFU, IRE, or cryotherapy— ... FT with cryotherapy, HIFU, and IRE is associated with good short-intermediate term oncological and functional outcomes.

3. renalandurologynews.com renalandurologynews.com/reports/prostate-cancer-focal-cryotherapy-offers-good-oncologic-outcomes/

Prostate Cancer Focal Cryotherapy Offers Good Oncologic ... Metastasis-free, cancer-specific, and overall survival rates at 5 years were 97%, 99%, and 96%, respectively. Post-ablation biopsy was performed ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1558767323001490

Survival After Cryotherapy Versus Radiotherapy in Low ... Recent research has demonstrated promising results for prostate cryoablation, with short-term biochemical control rates ranging from 80% to 90%, and a morbidity ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2023-09811

Focal Ablation with Focal Cryotherapy or High Intensity ... Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456921001140

Prostate Cancer Long-term Outcomes of Focal Cryotherapy ... Ten-year radical therapy–free or ADT-free, any treatment-free, metastasis-free, and overall survival were 51%, 40.2%, 93.9%, and 97%, respectively for FC.

7. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1534739/full

Oncological effects and complications of salvage ... Conclusions: Cryotherapy demonstrates a favorable safety profile and significant RFS benefits for salvage treatment of radio-recurrent PCa.