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Trial Title:
High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor
NCT ID:
NCT05755009
Condition:
Metastatic Cancer
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
Metastatic solid tumor
immune checkpoint inhibitors
radiotherapy
Objective response rate
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
High- and Low-dose radiotherapy
Description:
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.
Arm group label:
High- and Low-dose radiotherapy combined with immunotherapy
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with metastasis (including recurrence) solid tumors and failure with
first-line or above immunotherapy (PD-1/PD-L1/CTLA-4 inhibitors), and no subsequent
standard treatment regimen.
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:
-
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xiaochang Gong
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Gong X Xiaochang, MD
Phone:
+8613970020755
Email:
gxcanddw@sina.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaochang Gong, MD
Phone:
8613970020755
Email:
gxcanddw@163.com
Contact backup:
Last name:
Tianzhu Lu, Ph.D
Phone:
8615270186250
Email:
lutianzhu2008@163.com
Investigator:
Last name:
Jingao Li, MD
Email:
Principal Investigator
Start date:
March 1, 2023
Completion date:
February 20, 2025
Lead sponsor:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Source:
Jiangxi Provincial Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755009
