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High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor (ST-CR01)

Primary Purpose

Metastatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High- and Low-dose radiotherapy
Sponsored by
Jiangxi Provincial Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring Metastatic solid tumor, immune checkpoint inhibitors, radiotherapy, Objective response rate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiaochang Gong
  • Jiangxi Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High- and Low-dose radiotherapy combined with immunotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
the proportion of patients achieving the optimal overall remission (complete or partial remission)

Secondary Outcome Measures

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)
Overall survival (OS)
the time from the start of treatment to death from any cause
Safety evaluation
NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity)

Full Information

First Posted
February 23, 2023
Last Updated
March 6, 2023
Sponsor
Jiangxi Provincial Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05755009
Brief Title
High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor
Acronym
ST-CR01
Official Title
High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor: A Single-arm, Single-center, Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Provincial Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
Metastatic solid tumor, immune checkpoint inhibitors, radiotherapy, Objective response rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High- and Low-dose radiotherapy combined with immunotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
High- and Low-dose radiotherapy
Intervention 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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
the proportion of patients achieving the optimal overall remission (complete or partial remission)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
the time from the start of treatment to the first observation of disease progression or death from any cause (whichever occurs first)
Time Frame
two year
Title
Overall survival (OS)
Description
the time from the start of treatment to death from any cause
Time Frame
two years
Title
Safety evaluation
Description
NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity)
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Xiaochang Gong
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gong X Xiaochang, MD
Phone
+8613970020755
Email
gxcanddw@sina.com
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaochang Gong, MD
Phone
8613970020755
Email
gxcanddw@163.com
First Name & Middle Initial & Last Name & Degree
Tianzhu Lu, Ph.D
Phone
8615270186250
Email
lutianzhu2008@163.com
First Name & Middle Initial & Last Name & Degree
Jingao Li, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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