Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05522582
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yancheng First People's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Wei Geng, M.D.
Principal Investigator Affiliation	Yancheng First People's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Solid Tumors

Additional Details

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.

Arms & Interventions

Arms

Experimental: methotrexate+anti-PD-1 antibody+radiotherapy

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

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.

Contact a Trial Team

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International Sites

Yancheng First People's Hospital, Yancheng, Jiangsu, China

Status

Address

Yancheng First People's Hospital

Yancheng, Jiangsu, 224000

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