Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors
NCT05790447 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-03-30
Summary
This is an open-label, single-arm, Phase II investigator-initiated trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors.
Conditions
- Advanced Solid Tumor
- Refractory Tumor
Interventions
- DRUG
-
Thymalfasin
loading dose with thymalfasin based on the amounts of T lymphocyte
- RADIATION
-
Radiotherapy
hypofractionated radiotherapy/SBRT
- DRUG
-
PD-1/PD-L1 inhibitor
The PD-1/PD-L1 inhibitors are used within one week after radiotherapy
- DRUG
-
subcutaneous injection daily for 7 consecutive days
Sponsors & Collaborators
-
SciClone Pharmaceuticals
collaborator INDUSTRY -
Second Affiliated Hospital of Soochow University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2025-05-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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