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The purpose of this study is to explore the efficacy and safety of high- and low-dose radiotherapy (HD-RT/LD-RT) combined with envafolimab (I) in the treatment of metastatic solid tumors that have failed first-line immunotherapy or above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High- and Low-dose radiotherapy combined with immunotherapy | Experimental | High- and Low-dose radiotherapy combined with immunotherapy and maintain immunotherapy. Immunotherapy (Envafolimab) once every week (maintain total two years). Continuous high-(8Gy×5F) and low-dose (1.33Gy×5F) Radiotherapy starts at the second week after immunotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High- and Low-dose radiotherapy | Radiation | High- and Low-dose radiotherapy combined with immunotherapy and maintain immunotherapy. Immunotherapy (Envafolimab) once every week (maintain a total of two years). Continuous high-(8Gy×5F) and low-dose (1.33Gy×5F) Radiotherapy starts at the second week after immunotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | the proportion of patients achieving the optimal overall remission (complete or partial remission) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | the time from the start of treatment to the first observation of disease progression or death from any cause (whichever occurs first) | two year |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients with glioma or brain metastases. 2. Those with a history of severe immediate allergy to the drugs used in this study.
3. Suffered from other malignant tumors other than nasopharyngeal carcinoma within 5 years (except for tumors with an expected 5-year OS>90%, such as non-melanoma skin cancer or pre-invasive cervical cancer).
4. Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.
5. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction <50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist.
6. Received systemic anti-tumor therapy such as targeted therapy and biological drug therapy within 3 weeks before the first dose; Have received any Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 7 days before the first dose.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaochang Gong | Not yet recruiting | Nanchang | Jiangxi | 330000 | China |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
the time from the start of treatment to death from any cause
| two years |
| Safety evaluation | NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity) | two years |
| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
|