High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor

Study Overview
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Brief Summary
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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.

Official Title
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High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor: A Single-arm, Single-center, Phase II Trial

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Radiation: High- and Low-dose radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Previous histopathologic confirmation of malignancy. 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. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High- and Low-dose radiotherapy combined with immunotherapy<br>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. | Radiation: High- and Low-dose radiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | the proportion of patients achieving the optimal overall remission (complete or partial remission) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic solid tumor, immune checkpoint inhibitors, radiotherapy, Objective response rate