NCT03952065RecruitingPhase 2/3
IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)
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
Source: ClinicalTrials.gov · Last updated 26 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 13 May 2019
- Start date
- 1 Jan 2019
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- NCT number
- NCT03952065
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 200
- From 1 Jan 2019 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients participated in other clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
- Any agents which could affect the absorption or pharmacokinetics of the study drugs
Other illness
- 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;
- Allergic to adriamycin chemotherapy drugs，contrast agent or lipiodol;
Lab values
- Patients have poor compliance.
- Any contraindications for neck artery infusion procedure:
- 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).
Other
- Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
- Subjects unable to suffer the discomfort of the artery infusion procedure
Who the study is looking for
- 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
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guanzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.