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

• Sponsor: Jiangxi Provincial Cancer Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05755009
• Collaborator: (none)
• Enrollment: 33
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 23.7
• Patients Per Site: 16.5
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer	Radiation: High- and Low-dose radiotherapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 33 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor: A Single-arm, Single-center, Phase II Trial
• Actual Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Feb 20, 2024
• Anticipated Study Completion Date: Feb 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Objective response rate (ORR) [6 months]

   the proportion of patients achieving the optimal overall remission (complete or partial remission)

Secondary Outcome Measures

1. Progression-free survival (PFS) [two year]

   the time from the start of treatment to the first observation of disease progression or death from any cause (whichever occurs first)

2. Overall survival (OS) [two years]

   the time from the start of treatment to death from any cause

3. Safety evaluation [two years]

   NCI-CTCAE version 5.0 to assess adverse events (therapeutic toxicity)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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).

2. Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.

3. 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.

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xiaochang Gong	Nanchang	Jiangxi	China	330000
2	Jiangxi Cancer Hospital	Nanchang	Jiangxi	China	330029

Sponsors and Collaborators

• Jiangxi Provincial Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangxi Provincial Cancer Hospital
• ClinicalTrials.gov Identifier: NCT05755009
• Other Study ID Numbers: Solid tumor-CR01
• First Posted: Mar 6, 2023
• Last Update Posted: Mar 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jiangxi Provincial Cancer Hospital: Metastatic solid tumor; immune checkpoint inhibitors; radiotherapy; Objective response rate
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

No Results Posted as of Mar 7, 2023