Safety and Efficacy of Radiotherapy Combined With Immunotherapy for Advanced Malignant Tumors.

Advanced Solid Tumor Clinical Trial

Official title:

A Prospective Clinical Trial Evaluating the Safety and Efficacy of Radiotherapy Combined With Immunotherapy in Advanced Refractory Solid Malignancies After Standard Treatment Failure/Drug Resistance.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173219
• Other study ID #: 2023-ZF-63
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 15, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: December 2023
• Source: China-Japan Friendship Hospital
• Contact: Guangying Zhu, M.D.
• Phone: +86-010 84205381
• Email: zryyfa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to find a new radioimmunotherapy regimen for advanced malignancies with multiple metastatic after standard treatment failure/drug resistance. The main questions it aims to answer is: the safety and efficacy of the new regimen for advanced multiple metastatic solid tumors standard treatment failure/drug resistance, and explore the impact on immune function. Participants will receive the combination of radiotherapy and immunotherapy.

Description:

More effective treatment regimens remain to be explored for advanced malignancies with multiple metastatic after standard treatment failure/drug resistance. The combination of radiotherapy and immunotherapy is considered to be a promising therapeutic strategy. Studies showed the efficacy of PRaG (PD-1 inhibitor, Radiotherapy and GM-CSF) treatment and stereotactic radiotherapy (SBRT) combined with low-dose radiotherapy (LDRT) for advanced tumors. Therefore, the investigators designed a new radioimmunotherapy regimen, including SBRT, LDRT , PD-1/PD-L1 inhibitor, and GM-CSF. This study aimed to evaluate the safety and efficacy of the new regimen for advanced multiple metastatic solid tumors standard treatment failure/drug resistance, and explore the impact on immune function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. advanced malignant solid tumors with multiple metastases or relapses, with pathological diagnosis or medical record;

2. disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or rejection of standard treatment due to personal willingness;

3. patients with disease progression or drug resistance after previous immunotherapy are allowed to be included; a history of radiotherapy in the LDRT area or other sites is allowed to be included, provided that there are no residual toxic effects;

4. at least =1 lesion suitable for SBRT, and =1 lesion suitable for LDRT, and the above lesions must be measured;

5. no contraindications to radiotherapy;

6. Eastern Cooperative Oncology Group (ECOG) score: 0-2 points, and life expectancy >3 months;

7. important organ function is acceptable, defined as: white blood cells =3.0×10^9/L, platelets =75×10^9/L, hemoglobin =90g/L, glutamic pyruvic transaminase and glutamic oxalacetic transaminase =2.5 times the upper limit of normal value, serum creatinine < 178µmol/L;

8. voluntary participation and sign the informed consent.

Exclusion Criteria:

1. no suitable lesions for radiotherapy, or the limit of important organs at risk could not be met;

2. permanent discontinuation of PD-1/L1 inhibitors due to = grade 3 immune-related toxic reactions;

3. serious cardiovascular or cerebrovascular diseases, severe liver or kidney dysfunction, serious and uncontrolled systemic infections or other contraindications, or any contraindications to radiotherapy, and some comorbidities should be re-evaluated after symptomatic treatment;

4. any active immune system disease or related history;

5. systemic immunosuppressive drugs are expected to be used during the study;

6. a history of severe uncontrollable central nervous system diseases or mental disorders, which may hinder the signing of informed consent or treatment compliance;

7. other important medical or physiological conditions (such as pregnancy or breastfeeding status);

8. patients who are known to be allergic to the drugs used in this study;

9. patients refuse or are unable to sign the informed consent.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Combination Product:
• Radiotherapy combined with immunotherapy
(1) SBRT 8Gy×3f, (2) LDRT 2Gy ×3f, PD-1/L1 inhibitor, periodically, until the disease progresses or intolerable toxic side effects, (4) GM-CSF, 200ug/QD, subcutaneous injection, the first course of treatment for 7 days.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event rate	The proportion of treatment-related toxicities cases to the total evaluable cases, assessed according to CTCAE 5.0 criteria.	6 weeks
Secondary	Objective response rate	Proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit.	6 weeks
Secondary	Disease control rate	Proportion of patients who achieved remission (PR+CR) or stable lesion (SD) after treatment.	6weeks