NCT05522582

Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

Safety and Efficacy of Oral Methotrexate Tablets Combined With Immunotherapy During Radiotherapy for Unresectable/Metastatic Solid Tumors: a Single-center, Prospective Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Yancheng First People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Malignant tumor is a systemic and complex disease that seriously endangers human health, surgery is the preferred treatment for solid tumors. Due to the extensive invasion and metastasis of advanced tumors, radiotherapy and chemotherapy are the main treatment options. However, the tolerance of tumor to chemoradiotherapy often leads to treatment failure and poor prognosis. Immunotherapy provides a new approach for the systemic treatment of tumors, but the clinical efficacy is still limited. Therefore, it is important to find effective drugs to improve the tumor response to radiotherapy and immunotherapy. 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. The objective of this clinical trial is to explore the efficacy and safety of methotrexate combined with immunotherapy and radiotherapy in patients with unresectable/recurrence solid tumors.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Methotrexate tablets	Tablets with 5mg methotrexate are taken orally twice a week during the whole course of radiotherapy
DRUG	Anti-PD-1 monoclonal antibody	Anti-PD-1 monoclonal antibody 200mg is given intravenously every 3 weeks from the first day of radiotherapy until or after the end of treatment.
RADIATION	Radiotherapy	6～15MV X-ray, 2Gy/time, 5times/week. The duration of radiotherapy depends on the target lesion.

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-12-31
• Completion: 2026-12-31
• First posted: 2022-08-31
• Last updated: 2024-10-26

Locations

1 site across 1 country: China