Using high-intensity focused ultrasound with REGOTORI for metastatic colorectal cancer
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 is testing if using high-intensity focused ultrasound along with REGOTORI can help people with drug-resistant metastatic colorectal cancer feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT04819516 on ClinicalTrials.gov |
What this trial studies
This study explores the safety and effectiveness of combining high-intensity focused ultrasound (HIFU) with REGOTORI in patients suffering from drug-resistant metastatic colorectal cancer. Participants will receive localized HIFU treatment alongside REGOTORI, with clinical data collected at various follow-up points to assess outcomes. The study aims to gather comprehensive data, including laboratory results and imaging tests, to evaluate the treatment's impact on the patients' condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with metastatic colorectal cancer who have failed first and second-line treatments and have a target lesion suitable for HIFU.
Not a fit: Patients who are pregnant, have active infections, or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with metastatic colorectal cancer who have exhausted standard therapies.
How similar studies have performed: While the combination of HIFU and REGOTORI is a novel approach, similar studies using HIFU for cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
Where this trial is running
Hangzhou, Zhejiang
- the Second Affiliated Hospital of Medical College of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ying Yuan, Ph.D & MD
- Email: yuanying1999@zju.edu.cn
- Phone: +86-13858193601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.