Clinical trial · Interventional
Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors
Safety and Efficacy of Oral Methotrexate Tablets Combined With Immunotherapy During Radiotherapy for Unresectable/Metastatic Solid Tumors: a Single-center, Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
| Methotrexate tablets | Drug | Methotrexate | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- methotrexate+anti-PD-1 antibody+radiotherapy
- description
- Tablets with 5mg methotrexate are taken orally twice a week during radiotherapy. With anti-PD-1 monoclonal antibody, 200mg, Q3W.
- interventionNames
- Drug: Methotrexate tablets
- Drug: Anti-PD-1 monoclonal antibody
- Radiation: Radiotherapy
Primary outcomes (2)
- measure
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- timeFrame
- Up to 3 months
- description
- 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)
- measure
- Treatment-related adverse events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available