High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor
NCT ID: NCT05755009
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
33 participants
INTERVENTIONAL
2023-03-01
2025-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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High- and Low-dose radiotherapy combined with immunotherapy
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.
High- and Low-dose radiotherapy
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.
Interventions
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High- and Low-dose radiotherapy
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.
Eligibility Criteria
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Inclusion Criteria
2. Previous histopathologic confirmation of malignancy.
3. Tumor diameter \> 5 cm or the number of metastases is 6-15 (at least one measurable lesion, bone metastases are not used as target lesions), not suitable for conventional radiotherapy, surgery, radiofrequency ablation, and other treatments.
4. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months.
5. During the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, Chinese herbal medicine, and proprietary Chinese medicine.
6. 18-70 years old, no gender limit.
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
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Jiangxi Provincial Cancer Hospital
OTHER
Responsible Party
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Locations
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Xiaochang Gong
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Countries
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Facility Contacts
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Other Identifiers
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Solid tumor-CR01
Identifier Type: -
Identifier Source: org_study_id
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