Head/Neck NeoplasmPhase 2/3NCT03952065
IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)
A Phase 2/3 study testing PD1/PDL1/CTLA4 inhibitors in people with Head/Neck Neoplasm, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This trial was designed to investigate the survival outcomes, response rates, and safety of patients with advanced Head/Neck Squamous cancer via intra-tumor or intra-artery versus vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head/Neck Neoplasm
- What is being tested?
- PD1/PDL1/CTLA4 inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2035
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytohistological confirmation is required for diagnosis of HNC.
- Signed informed consent before recruiting.
- Age between 18 to 80 years with estimated survival over 3 months.
- ECOG score < 2
- Tolerable coagulation function or reversible coagulation disorders
- Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR < 2.3 or PT < 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin > 28 g/L；Total bilirubin < 51 μmol/L
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- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
- Patients with advanced HNC which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection and other treatment.
- Birth control.
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Who cannot join
- Patients participated in other clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
- Patients accompanied with other tumors or past medical history of malignancy;
- Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
- Patients have poor compliance.
- Any contraindications for neck artery infusion procedure:
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- Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%).
- Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C. Known severe atheromatosis. D. Known uncontrolled blood hypertension (> 160/100 mm/Hg).
- Allergic to adriamycin chemotherapy drugs，contrast agent or lipiodol;
- Any agents which could affect the absorption or pharmacokinetics of the study drugs
- Subjects unable to suffer the discomfort of the artery infusion procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, 510260
Hui Lian, MD, 02034153532, lian-hui-2008@163.com
Zhenfeng Zhang, MD, PhD, +862039195966, zhangzhf@gzhmu.edu.cn
About this study
Official title: A Phase II/III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1/CTLA4 Inhibitors or Their Combinations Via Neck Artery or Intratumor Versus Vein Infusion for Immunotherapy of HNC
This trial was designed to investigate the survival outcomes, response rates, and safety of patients with advanced Head/Neck Squamous cancer via intra-tumor or intra-artery versus vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations.
Read the detailed description
Head/Neck cancer is a kind of hard-to-treat malignancy worldwide and its overall survival rate is still low. PD1/PDL1/CTLA4 inhibitors are widely used to treat various of cancers now. Delivery of antibody drugs through interventional approaches including intra-tumor or intra-artery, based on the theory of "first pass effect" of drug, can significantly increase the local drug concentration of the tumor, improve the efficacy, and reduce systemic adverse reactions.
To the investigator's knowledge, no studies have been developed on the survival benefit of neck artery infusion or intra-tumor injection of immunotherapeutic agents in patients with advanced HNC. This phase II-III clinical trial was designed to compare the effects of PD1/PDL1/CTLA4 inhibitor or their combinations via IA/IT and IV on the survival benefit of patients with advanced HNC, including ORR, DCR, median survival time, and safety.
- Conditions
- Head/Neck Neoplasm
- Being tested
- PD1/PDL1/CTLA4 inhibitors
- Keywords
- Head/Neck tumor, PD1 antibody, Artery infusion, PDL1 antibody, CTLA4 antibody, Intra-tumor, Interventional therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD1/PDL1/CTLA4 inhibitorsDrug
Infusion of PD1/PDL1/CTLA4 inhibitors through peripheral vein or neck artery/intra-tumor.
| Study group | Role | What they receive |
|---|---|---|
| PD1/PDL1/CTLA4 inhibitor or their combinations infusion via neck artery | Experimental | Interventional technique is used to localize neck artery to infuse the inhibitor or their combinations directly into tumor. Receives: Drug: PD1/PDL1/CTLA4 inhibitors |
| PD1/PDL1/CTLA4 inhibitor or their combinations infusion via peripheral vein | Experimental | Routine peripheral vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations is performed. Receives: Drug: PD1/PDL1/CTLA4 inhibitors |
| PD1/PDL1/CTLA4 inhibitor or their combinations infusion via intra-tumor penetration | Experimental | Interventional technique is used to intra-tumor injection of the inhibitor or their combinations directly into tumor. Receives: Drug: PD1/PDL1/CTLA4 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
Measured: 2 years
Secondary outcomes (2)
Progression-free survival
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Measured: 2 years
Adverse event rate
Adverse event rate will be defined as the rate of patients who developed adverse event.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head/Neck NeoplasmStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Lian, MD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical UniversityZhenfeng Zhang, MD, PhD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952065
- Sponsor's protocol ID
- ZZITICI-009
- Status last verified
- Jun 2024
- First submitted
- 13 May 2019
- Last updated
- 26 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ou Y, Zhang J, Tan H, He B, Li T, Liu M, Zhi C, Huang J, Li M, Zuo S, Shah NUH, Chen Y, Huang J, Chen D, Qin R, Li X, Lian H, Wu Q, Yang H, Zhang Z. CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. Front Immunol. 2026 Jul 24;17:1869154. doi: 10.3389/fimmu.2026.1869154. eCollection 2026.
PubMed 42568612
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1/CTLA4 Inhibitors or Their Combinations Via Neck Artery or Intratumor Versus Vein Infusion for Immunotherapy of HNC
- ClinicalTrials.gov ID
- NCT03952065
- Acronym / sponsor ID
- ZZITICI-009
- Conditions
- Head/Neck Neoplasm
- Keywords
- Head/Neck tumor, PD1 antibody, Artery infusion, PDL1 antibody, CTLA4 antibody, Intra-tumor, Interventional therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 16 May 2019 (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 trial was designed to investigate the survival outcomes, response rates, and safety of patients with advanced Head/Neck Squamous cancer via intra-tumor or intra-artery versus vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations.
Detailed description
Head/Neck cancer is a kind of hard-to-treat malignancy worldwide and its overall survival rate is still low. PD1/PDL1/CTLA4 inhibitors are widely used to treat various of cancers now. Delivery of antibody drugs through interventional approaches including intra-tumor or intra-artery, based on the theory of "first pass effect" of drug, can significantly increase the local drug concentration of the tumor, improve the efficacy, and reduce systemic adverse reactions.
To the investigator's knowledge, no studies have been developed on the survival benefit of neck artery infusion or intra-tumor injection of immunotherapeutic agents in patients with advanced HNC. This phase II-III clinical trial was designed to compare the effects of PD1/PDL1/CTLA4 inhibitor or their combinations via IA/IT and IV on the survival benefit of patients with advanced HNC, including ORR, DCR, median survival time, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PD1/PDL1/CTLA4 inhibitor or their combinations infusion via neck artery | Experimental | Drug: PD1/PDL1/CTLA4 inhibitorsInterventional technique is used to localize neck artery to infuse the inhibitor or their combinations directly into tumor. |
| PD1/PDL1/CTLA4 inhibitor or their combinations infusion via peripheral vein | Experimental | Drug: PD1/PDL1/CTLA4 inhibitorsRoutine peripheral vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations is performed. |
| PD1/PDL1/CTLA4 inhibitor or their combinations infusion via intra-tumor penetration | Experimental | Drug: PD1/PDL1/CTLA4 inhibitorsInterventional technique is used to intra-tumor injection of the inhibitor or their combinations directly into tumor. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Cytohistological confirmation is required for diagnosis of HNC.
- Signed informed consent before recruiting.
- Age between 18 to 80 years with estimated survival over 3 months.
- ECOG score < 2
- Tolerable coagulation function or reversible coagulation disorders
Key exclusion criteria (11 listed)
- Patients participated in other clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
- Patients accompanied with other tumors or past medical history of malignancy;
- Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
- Patients have poor compliance.
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 |
|---|---|---|
| PD1/PDL1/CTLA4 inhibitorsInfusion of PD1/PDL1/CTLA4 inhibitors through peripheral vein or neck artery/intra-tumor. | Drug | PD1/PDL1/CTLA4 inhibitor or their combinations infusion via intra-tumor penetration, PD1/PDL1/CTLA4 inhibitor or their combinations infusion via neck artery, PD1/PDL1/CTLA4 inhibitor or their combinations infusion via peripheral vein |
Primary outcome
Overall survival
Time frame: 2 years
Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
2 secondary outcomes
Progression-free survival
Time frame: 2 years
Adverse event rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Derived from this study: PubMed 42568612Ou Y, Zhang J, Tan H, He B, Li T, Liu M, Zhi C, Huang J, Li M, Zuo S, Shah NUH, Chen Y, Huang J, Chen D, Qin R, Li X, Lian H, Wu Q, Yang H, Zhang Z. CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. Front Immunol. 2026 Jul 24;17:1869154. doi: 10.3389/fimmu.2026.1869154. eCollection 2026.
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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.
Hui Lian, MD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
Zhenfeng Zhang, MD, PhD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PD1/PDL1/CTLA4 inhibitors in people with Head/Neck Neoplasm, run by Second Affiliated Hospital of Guangzhou Medical University 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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 26 Jun 2024. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Lian, MD (02034153532, lian-hui-2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952065, which also lists 1 linked publication.
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 26 Jun 2024.