Objective Response RatePhase 2NCT05760196
Radiotherapy Combined With PD-1 Inhibitor and GM-CSF for Advanced Recurrent Metastatic Head and Neck Tumors
A Phase 2 study testing GM-CSF in people with Objective Response Rate, run by Xiangpan Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Objective Response Rate
- What is being tested?
- GM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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%;
- Myocardial enzyme profile and NT-proBNP do not exceed twice the upper limit of normal;
- Troponin and CKMB values do not exceed twice the normal upper limit;
- Patients who have had grade 2 or higher AV block in the past six months and need to consider pacemakers will not be included;
- Blood pressure hypertension≤ 160mmHg and/or low pressure≤90mmHg. 1 week prior to enrollment, the level of organ function meets the following criteria:
- Bone marrow function: hemoglobin ≥ 80g/L, white blood cell count ≥ 3.510^9/L or neutrophil count ≥1.510^9/L, platelet count ≥ 10010^9/L, CD8+ T lymphocyte absolute value ≥200/μL; Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, when the serum total bilirubin level > 1.5 times the upper limit of normal, direct bilirubin level must ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal; (5.0 times ≤the upper limit of normal in patients with liver metastases); Kidney: serum creatinine level < 1.5 times the upper limit of normal or creatinine clearance ≥ 50ml/min, urea nitrogen ≤ 200mg/L; serum albumin≥ 30g/L;
- Patients must have the ability to understand and voluntarily sign informed consent forms.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430061
Xiangpan Li, PhD, +862788041911, rm001227@whu.edu.cn
About this study
Official title: 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
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.
- Conditions
- Objective Response Rate
- Being tested
- GM-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFDrug
Also called PD-1 antibody
PD1 antibody is held every three weeks, and GM-CSF is used once every three weeks on days 1-14. Until the patient progresses disease or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent or metastatic advanced head and neck malignancy | Experimental | 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 Receives: Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective tumor response, including CR and PR, was assessed using RECIST version 1.1.
Measured: 36 months
Secondary outcomes (5)
Toxic reaction
Guidelines for Toxicity Management of CTC 5.0 Standard CSCO ESMO irAE.
Measured: 36 months
Overall survival
The time between enrolment in the study and death from any cause.
Measured: 36 months
Duration of remission
The time from the first confirmed CR or PR to the first occurrence of PD, or to death if it occurs during treatment.
Measured: 36 months
Disease control rate
Refers to the percentage of cases with CR, PR, and SD (≥4 weeks) in patients with evaluable efficacy.
Measured: 36 months
Progression-free survival
The time between initial use of the investigational drug and tumor progression/recurrence or death from any cause
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Objective Response RateStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangpan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangpan Li, Renmin Hospital of Wuhan University
- Investigators
- Xiangpan Li, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760196
- Sponsor's protocol ID
- WDRY2022-K266
- Status last verified
- Feb 2023
- First submitted
- 25 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05760196
- Acronym / sponsor ID
- WDRY2022-K266
- Conditions
- Objective Response Rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Xiangpan LiUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 8 Mar 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent or metastatic advanced head and neck malignancy | Experimental | Drug: GM-CSFPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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);
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| GM-CSFAlso: PD-1 antibodyPD1 antibody is held every three weeks, and GM-CSF is used once every three weeks on days 1-14. Until the patient progresses disease or intolerable toxicity. | Drug | Recurrent or metastatic advanced head and neck malignancy |
Primary outcome
Objective response rate (ORR)
Time frame: 36 months
Objective tumor response, including CR and PR, was assessed using RECIST version 1.1.
5 secondary outcomes
Toxic reaction
Time frame: 36 months
Overall survival
Time frame: 36 months
Duration of remission
Time frame: 36 months
Disease control rate
Time frame: 36 months
Progression-free survival
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
Related trials for Objective Response Rate
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Neoadjuvant Immunochemotherapy and Postoperative Adjuvant Immunotherapy for Head and Neck Squamous Cell Carcinoma Invading the Skull Base
Head and Neck Cancer Squamous Cell Carcinoma, Skull Base--Cancer
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.
Xiangpan Li principal investigator
Renmin Hospital of Wuhan University
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 GM-CSF in people with Objective Response Rate, run by Xiangpan Li 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 16 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangpan Li, PhD (+86-027-88041911, rm001227@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 36 months). 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 8 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.