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ACTIVE NOT RECRUITING
NCT05522582
PHASE2

Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

Sponsor: Yancheng First People's Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2021-11-15

Completion Date

2026-12-31

Last Updated

2024-10-26

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Yancheng First People's Hospital

Yancheng, Jiangsu, China