Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIFU with REGOTORI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-intensity focused ultrasound therapy | Procedure | Patients will receive high-intensity focused ultrasound therapy in local site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 3 months from baseline | |
| Adverse events | 6 months from baseline | |
| Adverse events | 9 months from baseline | |
| Adverse events | 12 months from baseline | |
| Number of Participants With Abnormal Laboratory Values | 3 months from baseline | |
| Number of Participants With Abnormal Laboratory Values | 6 months from baseline | |
| Number of Participants With Abnormal Laboratory Values | 9 months from baseline | |
| Number of Participants With Abnormal Laboratory Values | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Tumor markers | 12 months from baseline | |
| Number of Participants With Abnormal Tumor markers | 3 months from baseline | |
| Number of Participants With Abnormal Tumor markers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Yuan, Ph.D & MD | Contact | +86-13858193601 | yuanying1999@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ying Yuan, Ph.D & MD | The Second Affiliated Hospital of Medical College of Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Medical College of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| C000656314 | toripalimab |
| C559147 | regorafenib |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Toripalimab | Drug | Toripalimab plus regorafenib |
|
|
| 6 months from baseline |
| Number of Participants With Abnormal Tumor markers | 9 months from baseline |
| Disease Control Rate | From Baseline to primary completion date, about 60 months |
| Progression Free Survival | From Baseline to primary completion date, about 60 months |
| 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. | 12 months from baseline |
| Numeric rating scale | Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain | 12 months from baseline |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |