Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

NCT05522582 | Active Not Recruiting Phase 2

• 1 other identifier: 2021-K-099
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Solid Tumors

Keywords

anti-PD-1 monoclonal antibody, radiotherapy, methotrexate

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions)

  Up to 3 months

• Treatment-related adverse events (AEs)

  Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0

  Up to 6 months

Secondary Outcomes (4)

• Numbers of CD3+, CD4+ and CD8+T lymphocyte subsets in peripheral blood detected by flow cytometry

  Approximately 2 months

• Levels of IL-6, TNF-α and IFN-γ in peripheral blood detected by flow cytometry

  Approximately 2 months

• Progression-free Survival (PFS) per RECIST 1.1

  Up to 12 months

• Overall Survival (OS)

  Up to 36 months

Study Arms (1)

methotrexate+anti-PD-1 antibody+radiotherapy

EXPERIMENTAL

Tablets with 5mg methotrexate are taken orally twice a week during radiotherapy. With anti-PD-1 monoclonal antibody, 200mg, Q3W.

Drug: Methotrexate tablets; Drug: Anti-PD-1 monoclonal antibody; Radiation: Radiotherapy

Interventions

Methotrexate tablets DRUG

Tablets with 5mg methotrexate are taken orally twice a week during the whole course of radiotherapy

Also known as: MTX

methotrexate+anti-PD-1 antibody+radiotherapy

Anti-PD-1 monoclonal antibody DRUG

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.

Also known as: PD-1 inhibitors

methotrexate+anti-PD-1 antibody+radiotherapy

Radiotherapy RADIATION

6～15MV X-ray, 2Gy/time, 5times/week. The duration of radiotherapy depends on the target lesion.

methotrexate+anti-PD-1 antibody+radiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have unresectable/ metastatic solid tumors;
• ≥ 18 years old;
• Life expectancy of at least 3 months;
• Eastern Cooperative Oncology Group performance status 0-2;
• Have at least one measurable lesion ≥ 1 cm as defined by response criteria;
• Adequate organ function.

You may not qualify if:

• Subjects with a history of autoimmune diseases or syndromes;
• Serious uncontrolled medical disorders or active infections;
• Women who are pregnant or breastfeeding;
• 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.

Sponsors & Collaborators

• Yancheng First People's Hospital: lead

Study Sites (1)

Yancheng First People's Hospital

Yancheng, Jiangsu, 224000, China

Location

MeSH Terms

Interventions

Methotrexate; spartalizumab; Immune Checkpoint Inhibitors; Radiotherapy

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Study Officials

• Wei Geng, M.D.

  Yancheng First People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: August 31, 2022
• Study Start: November 15, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)