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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer
• Intervention / Treatment: Radiation: High- and Low-dose radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • Jiangxi Cancer Hospital
      • Contact: Tianzhu Lu, Ph.D; Phone Number: 8615270186250; Email: lutianzhu2008@163.com
      • Principal Investigator: Jingao Li, MD
    • Nanchang, Jiangxi, China, 330000
      • Not yet recruiting
      • Xiaochang Gong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jiangxi Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): February 20, 2024
• Study Completion (Anticipated): February 20, 2025

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: radiotherapy; Metastatic solid tumor; Objective response rate; immune checkpoint inhibitors
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: Solid tumor-CR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No