Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Immune checkpoint inhibitors, such as programmed death 1 (PD-1) and programmed cell death-Ligand 1 (PD-L1), offer new approaches for systemic treatment of tumors, but clinical efficacy remains limited. Previous studies by our team have found that methotrexate can activate anti-tumor immunity. The discovery of a new effect of this drug will improve tumor response to immunotherapy and prognosis of patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Institute of Materia Medica, Chinese Academy of Sciences
• Collaborator: Yancheng First People's Hospital
• Treatments: Antibodies; Antibodies, Monoclonal; Immune Checkpoint Inhibitors; Methotrexate

Criteria

Inclusion Criteria:

1. Subjects have unresectable/ metastatic solid tumors;

2. ≥ 18 years old;

3. Life expectancy of at least 3 months;

4. Eastern Cooperative Oncology Group performance status 0-2;

5. Have at least one measurable lesion ≥ 1 cm as defined by response criteria;

6. Adequate organ function.

Exclusion Criteria:

1. Subjects with a history of autoimmune diseases or syndromes;

2. Serious uncontrolled medical disorders or active infections;

3. Women who are pregnant or breastfeeding;

4. Subjects have other factors that may cause them to terminate the study, such as other serious medical conditions (including mental illness) that require combined treatment.