Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522582
• Other study ID #: 2021-K-099
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Yancheng First People's Hospital
• Contact: Wei Geng, M.D.
• Phone: 86-0515-66696967
• Email: weihuo2001[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• Methotrexate tablets
Tablets with 5mg methotrexate are taken orally twice a week during the whole course of radiotherapy
• 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

Country	Name	City	State
China	Yancheng First People's Hospital	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yancheng First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Numbers of CD3+, CD4+ and CD8+T lymphocyte subsets in peripheral blood detected by flow cytometry	Laboratory tests for T-cell detection will be performed before and after treatment.	Approximately 2 months
Secondary	Levels of IL-6, TNF-a and IFN-? in peripheral blood detected by flow cytometry	Peripheral blood will be collected before, during and after treatment for laboratory serum cytokine detection.	Approximately 2 months
Secondary	Progression-free Survival (PFS) per RECIST 1.1	PFS is defined as the time from enrollment to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.	Up to 12 months
Secondary	Overall Survival (OS)	OS is defined as the time from enrollment to death from any cause during the course of the study.	Up to 36 months