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

NCT06173219 | Recruiting Phase 1

• 1 other identifier: 2023-ZF-63
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

advanced solid tumor; standard treatment failure; radiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Objective response rate

  6 weeks

• Disease control rate

  6weeks

Study Arms (1)

treatment group

EXPERIMENTAL

The subjects will receive the combination therapy of SBRT, LDRT, PD-1/L1 inhibitor and GMCSF. The specific treatment regimen is as follows: (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.

Combination Product: Radiotherapy combined with immunotherapy

Interventions

Radiotherapy combined with immunotherapy COMBINATION_PRODUCT

(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.

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• advanced malignant solid tumors with multiple metastases or relapses, with pathological diagnosis or medical record;
• disease progression or recurrence after standard treatment, or unsuitable/intolerable for standard treatment, or rejection of standard treatment due to personal willingness;
• 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;
• at least ≥1 lesion suitable for SBRT, and ≥1 lesion suitable for LDRT, and the above lesions must be measured;
• no contraindications to radiotherapy;
• Eastern Cooperative Oncology Group (ECOG) score: 0-2 points, and life expectancy \>3 months;
• 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;
• voluntary participation and sign the informed consent.

You may not qualify if:

• no suitable lesions for radiotherapy, or the limit of important organs at risk could not be met;
• permanent discontinuation of PD-1/L1 inhibitors due to ≥ grade 3 immune-related toxic reactions;
• 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;
• any active immune system disease or related history;
• systemic immunosuppressive drugs are expected to be used during the study;
• a history of severe uncontrollable central nervous system diseases or mental disorders, which may hinder the signing of informed consent or treatment compliance;
• other important medical or physiological conditions (such as pregnancy or breastfeeding status);
• patients who are known to be allergic to the drugs used in this study;
• patients refuse or are unable to sign the informed consent.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Guangying Zhu, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangying Zhu, M.D.

CONTACT

+86-010 84205381; zryyfa@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available starting 6 months and ending 5 years following article publication.
• Access Criteria: People who provide reasonable research protocols can get access to the data by contacting the researchers.

Locations

CN (1)