Solid TumorsPhase 2NCT05522582
Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors
A Phase 2 study testing Methotrexate tablets, Anti-PD-1 monoclonal antibody and Radiotherapy in people with Solid Tumors, run by Yancheng First People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Methotrexate tablets, Anti-PD-1 monoclonal antibody and Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2021to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Oral Methotrexate Tablets Combined With Immunotherapy During Radiotherapy for Unresectable/Metastatic Solid Tumors: a Single-center, Prospective Study
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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- Methotrexate tablets, Anti-PD-1 monoclonal antibody, Radiotherapy
- Keywords
- anti-PD-1 monoclonal antibody, radiotherapy, methotrexate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate tabletsDrug
Also called MTX
Tablets with 5mg methotrexate are taken orally twice a week during the whole course of radiotherapy
Anti-PD-1 monoclonal antibodyDrug
Also called PD-1 inhibitors
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.
RadiotherapyRadiation
6～15MV X-ray, 2Gy/time, 5times/week. The duration of radiotherapy depends on the target lesion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Methotrexate tablets; Drug: Anti-PD-1 monoclonal antibody; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 3 months
Treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
Measured: Up to 6 months
Secondary outcomes (4)
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.
Measured: Approximately 2 months
Levels of IL-6, TNF-α and IFN-γ in peripheral blood detected by flow cytometry
Peripheral blood will be collected before, during and after treatment for laboratory serum cytokine detection.
Measured: Approximately 2 months
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.
Measured: Up to 12 months
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause during the course of the study.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start15 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yancheng First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Geng, Yancheng First People's Hospital
- Investigators
- Wei Geng, M.D., Study director, Yancheng First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522582
- Sponsor's protocol ID
- 2021-K-099
- Status last verified
- Oct 2024
- First submitted
- 28 Aug 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Oral Methotrexate Tablets Combined With Immunotherapy During Radiotherapy for Unresectable/Metastatic Solid Tumors: a Single-center, Prospective Study
- ClinicalTrials.gov ID
- NCT05522582
- Acronym / sponsor ID
- 2021-K-099
- Conditions
- Solid Tumors
- Keywords
- anti-PD-1 monoclonal antibody, radiotherapy, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yancheng First People's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methotrexate+anti-PD-1 antibody+radiotherapy | Experimental | Drug: Methotrexate tablets, Drug: Anti-PD-1 monoclonal antibody, Radiation: RadiotherapyTablets with 5mg methotrexate are taken orally twice a week during radiotherapy. With anti-PD-1 monoclonal antibody, 200mg, Q3W. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate tabletsAlso: MTXTablets with 5mg methotrexate are taken orally twice a week during the whole course of radiotherapy | Drug | methotrexate+anti-PD-1 antibody+radiotherapy |
| Anti-PD-1 monoclonal antibodyAlso: PD-1 inhibitorsAnti-PD-1 monoclonal antibody 200mg is given intravenously every 3 weeks from the first day of radiotherapy until or after the end of treatment. | Drug | methotrexate+anti-PD-1 antibody+radiotherapy |
| Radiotherapy6～15MV X-ray, 2Gy/time, 5times/week. The duration of radiotherapy depends on the target lesion. | Radiation | methotrexate+anti-PD-1 antibody+radiotherapy |
Primary outcome
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 3 months
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)
Treatment-related adverse events (AEs)
Time frame: Up to 6 months
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
4 secondary outcomes
Numbers of CD3+, CD4+ and CD8+T lymphocyte subsets in peripheral blood detected by flow cytometry
Time frame: Approximately 2 months
Levels of IL-6, TNF-α and IFN-γ in peripheral blood detected by flow cytometry
Time frame: Approximately 2 months
Progression-free Survival (PFS) per RECIST 1.1
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Geng, M.D. study director
Yancheng First People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate tablets, Anti-PD-1 monoclonal antibody and Radiotherapy in people with Solid Tumors, run by Yancheng First People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.