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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05755009
Other study ID # Solid tumor-CR01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date February 20, 2025

Study information

Verified date March 2023
Source Jiangxi Provincial Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 33
Est. completion date February 20, 2025
Est. primary completion date February 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
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.

Locations

Country Name City State
China Jiangxi Cancer Hospital Nanchang Jiangxi
China Xiaochang Gong Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) the proportion of patients achieving the optimal overall remission (complete or partial remission) 6 months
Secondary 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
Secondary Overall survival (OS) the time from the start of treatment to death from any cause two years
Secondary Safety evaluation NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity) two years
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