Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Methotrexate tablets

Intervention Type DRUG

Tablets with 5mg methotrexate are taken orally twice a week during the whole course of radiotherapy

Anti-PD-1 monoclonal antibody

Intervention Type DRUG

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.

Radiotherapy

Intervention Type RADIATION

6～15MV X-ray, 2Gy/time, 5times/week. The duration of radiotherapy depends on the target lesion.

Interventions

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Methotrexate tablets

Tablets with 5mg methotrexate are taken orally twice a week during the whole course of radiotherapy

Intervention Type 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.

Intervention Type DRUG

Radiotherapy

6～15MV X-ray, 2Gy/time, 5times/week. The duration of radiotherapy depends on the target lesion.

Intervention Type RADIATION

Other Intervention Names

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MTX PD-1 inhibitors

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No