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Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

NCT05522582 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-26

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Yancheng First People's Hospital

    lead OTHER

Principal Investigators

  • Wei Geng, M.D. · Yancheng First People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05522582 on ClinicalTrials.gov