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Trial Title:
Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors
NCT ID:
NCT05522582
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Methotrexate
Immune Checkpoint Inhibitors
Antibodies
Antibodies, Monoclonal
Conditions: Keywords:
anti-PD-1 monoclonal antibody, radiotherapy, methotrexate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Methotrexate tablets
Description:
Tablets with 5mg methotrexate are taken orally twice a week during the whole course of
radiotherapy
Arm group label:
methotrexate+anti-PD-1 antibody+radiotherapy
Other name:
MTX
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
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.
Arm group label:
methotrexate+anti-PD-1 antibody+radiotherapy
Other name:
PD-1 inhibitors
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
6～15MV X-ray, 2Gy/time, 5times/week. The duration of radiotherapy depends on the target
lesion.
Arm group label:
methotrexate+anti-PD-1 antibody+radiotherapy
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.
Detailed 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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yancheng First People's Hospital
Address:
City:
Yancheng
Zip:
224000
Country:
China
Start date:
November 15, 2021
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Yancheng First People's Hospital
Agency class:
Other
Source:
Yancheng First People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05522582
