A Prospective, Multicenter, High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors and GM-CSF in the Treatment of Advanced Recurrent Metastatic Head and Neck Tumors

Xiangpan Li1 site in 1 country56 target enrollmentOctober 1, 2022

ConditionsObjective Response Rate

InterventionsGM-CSF

DrugsGM-CSF

Overview

Phase: Phase 2
Intervention: GM-CSF
Conditions: Objective Response Rate
Sponsor: Xiangpan Li
Enrollment: 56
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an intervention study, aiming to use high and low dose radiotherapy combined with PD-1/PD-L1 inhibitor combined with GM-CSF to observe the effect of anti-tumor immunity and long-term therapeutic response rate, and to explore a new treatment model for patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

September 30, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Xiangpan Li

Responsible Party

Sponsor Investigator

Principal Investigator

Xiangpan Li

Professor

Renmin Hospital of Wuhan University

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old;
•Patients with recurrent or metastatic advanced head and neck malignancies (including nasopharyngeal malignancies), with a clear pathological diagnosis, imaging diagnosis, and medical history, no clearly recommended standard treatment regimen or inability to tolerate standard treatment regimens, and clear measurable lesions (\>1 cm);
•Patients with squamous cell carcinoma who progress after first-line antineoplastic therapy must include a platinum-containing combination chemotherapy or platinum-based concurrent chemoradiotherapy, and patients with secondary resistance after previous anti-PD-1/L1 therapy may also be enrolled;
•There is no standard regimen recommended by guidelines after first-line treatment failure in patients with non-squamous cell carcinoma (eg, adenoid cystadenocarcinoma, lung metastases, sarcoma, etc.);
•At least one lesion with a diameter of 1 cm to 5 cm (metastases ≥1 cm, if the patient has large metastases, partial tumor irradiation can be allowed) can be treated with radiation therapy at 16 to 24 Gy/2-3Fx doses; Lymph nodes can be used as stand-alone measurable lesions (if lymph nodes are evaluated as an evaluation lesion, they must meet the criteria for target lesions, see RECIST1.1 for definition of a lymph node target lesion);
•Patients who have previously received radical radiotherapy need to have an interval of more than 6 months; Patients with an interval of more than 6 months from the previous radiotherapy;
•In the past 6 months, there has been no acute coronary syndrome or malignant arrhythmia;
•ECOG (Eastern Cooperative Oncology Group), score 0-2, life expectancy assessment ≥ 3 months;
•There were no previous severe hematopoietic, cardiac, pulmonary, hepatic, or renal dysfunction or immunodeficiency;
•Ejection fraction of cardiac color Doppler ultrasound ≥ 50%;

Exclusion Criteria

•Exclude single shot oligo transfer;
•Pregnant or breastfeeding women;
•Those who have a history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ;
•Patients with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders, as judged by the investigator, may hinder the signing of informed consent or affect the patient's adherence to drug therapy;
•Clinically severe (i.e., active) heart disease such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more congestive heart failure or severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months;
•Organ transplantation requires immunosuppressive therapy;
•Known major active infection, or major blood, kidney, metabolic, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant diseases. Those who are allergic to any of the ingredients used in the study;
•Those with a history of immunodeficiency, including those who test positive for HIV or have other acquired or congenital immunodeficiency disorders, or have a history of organ transplantation, or who have other immune-related disorders that require long-term oral hormone therapy;
•Are in the period of acute and chronic TB infection (positive T-spot test, chest x-ray in patients with suspected tuberculosis);
•Other circumstances that the investigator does not consider suitable for inclusion.

Arms & Interventions

Recurrent or metastatic advanced head and neck malignancy

Patients with a clear pathological diagnosis, imaging diagnosis, and history, no clear recommended standard treatment or inability to tolerate standard treatment, and a clear measurable lesion

Intervention: GM-CSF