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Colorectal CancerPhase 1NCT04819516

Study of the Safety and Effectiveness of HIFU Combined With REGOTORI for Metastatic Colorectal Cancer

A Phase 1 study testing high-intensity focused ultrasound therapy and Toripalimab in people with Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study intends to perform high-intensity focused ultrasound combined with REGOTORI in patients with multiline drug-resistant metastatic colorectal cancer to explore the safety and efficacy of patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
high-intensity focused ultrasound therapy and Toripalimab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
7 Dec 2020to Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has metastatic colorectal cancer, and the first and second-line standard treatments have failed
  • There is at least one target lesion that can be treated with HIFU
  • Voluntarily accept this treatment clinical research, and sign the "Subject Informed Consent"
  • 18-75 years old, no gender limit
  • The level of physical strength of the Eastern Cooperative Oncology Group (ECOG): PS<=2
  • The expected survival time is greater than 3 months
  • No chemotherapy or radiotherapy within 21 days before enrollment
  • The function of major organs is basically normal

Who cannot join

  • Pregnant or lactating women
  • People infected with HIV, hepatitis C virus and Treponema pallidum
  • There is an active infection that requires systemic treatment (such as active tuberculosis)
  • Severe infection within 4 weeks before starting the study treatment
  • Subjects who have received allogeneic tissue/solid organ transplantation
  • The patient suffers from major vascular disease or irregular bleeding disease
Show all 14Show fewer
  • Suffer from physiological or pathological malnutrition diseases, chronic diarrhea, cachexia, etc.
  • The patient has autoimmune diseases, such as (but not limited to) multiple sclerosis, systemic lupus erythematosus and inflammatory bowel disease, vitiligo
  • The patient has a history of serious drug or food allergy (for example, allergy to protein)
  • The patient has serious heart disease (including but not limited to: myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia, etc.), severe liver and kidney damage, uncontrolled blood sugar and blood pressure (the subject's blood pressure, After using antihypertensive drugs, it still cannot be controlled within the normal range; fasting blood glucose is still >10mmol/L after using antihypertensive drugs)
  • The patient has uncontrollable seizures or loss of insight due to mental illness
  • In the 12 months before screening, the patient has a history of drug abuse, drug abuse, and long-term alcoholism
  • Within 3 months before screening, the patient is participating in other clinical studies
  • Other situations that cannot participate in clinical research.

Trial locations and contacts

1 site in 1 country.

Ying Yuan, Ph.D & MD contact

+86-13858193601

yuanying1999@zju.edu.cn

China1 site, 1 recruiting

  • the Second Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, Zhejiang, 310000

    Ying Yuan, Ph.D & MD, +86-13858193601, yuanying1999@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Single-center Exploratory Study of the Safety and Effectiveness of High-intensity Focused Ultrasound Therapy Combined With REGOTORI for Metastatic Colorectal Cancer

This study intends to perform high-intensity focused ultrasound combined with REGOTORI in patients with multiline drug-resistant metastatic colorectal cancer to explore the safety and efficacy of patients. Patients receive HIFU local treatment combined with REGOTORI treatment, and receive corresponding clinical data collection at different follow-up points, including necessary data from various laboratories, CT/MRI, and immune function tests that are exactly the same as before surgery collection.

Being tested
high-intensity focused ultrasound therapy, Toripalimab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-intensity focused ultrasound therapyProcedure or surgery

    Patients will receive high-intensity focused ultrasound therapy in local site.

  • ToripalimabDrug

    Also called Regorafenib

    Toripalimab plus regorafenib

Study groups in NCT04819516
Study groupRoleWhat they receive
HIFU with REGOTORIExperimentalNot described
Receives: Procedure: high-intensity focused ultrasound therapy; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Measured: 3 months from baseline

  2. Adverse events

    Measured: 6 months from baseline

  3. Adverse events

    Measured: 9 months from baseline

  4. Adverse events

    Measured: 12 months from baseline

  5. Number of Participants With Abnormal Laboratory Values

    Measured: 3 months from baseline

  6. Number of Participants With Abnormal Laboratory Values

    Measured: 6 months from baseline

  7. Number of Participants With Abnormal Laboratory Values

    Measured: 9 months from baseline

  8. Number of Participants With Abnormal Laboratory Values

    Measured: 12 months from baseline

Secondary outcomes (8)

  1. Number of Participants With Abnormal Tumor markers

    Measured: 12 months from baseline

  2. Number of Participants With Abnormal Tumor markers

    Measured: 3 months from baseline

  3. Number of Participants With Abnormal Tumor markers

    Measured: 6 months from baseline

  4. Number of Participants With Abnormal Tumor markers

    Measured: 9 months from baseline

  5. Disease Control Rate

    Measured: From Baseline to primary completion date, about 60 months

  6. Progression Free Survival

    Measured: From Baseline to primary completion date, about 60 months

  7. QoL

    Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.

    Measured: 12 months from baseline

  8. Numeric rating scale

    Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain

    Measured: 12 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start7 Dec 2020
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819516
Sponsor's protocol ID
HIFUREGONIVO2101
Status last verified
Mar 2021
First submitted
27 Jan 2021
Last updated
29 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing high-intensity focused ultrasound therapy and Toripalimab in people with Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Yuan, Ph.D & MD (+86-13858193601, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 3 months from baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.

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