Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma (NCT04156698) | Clinical Trial Compass
UnknownPhase 2
Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma
China51 participantsStarted 2020-05-21
Plain-language summary
This is a single-center, multidisciplinary, open-label, single-arm prospective clinical study.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients have histologically confirmed hypopharyngeal squamous cell carcinoma and require total laryngectomy, including the piriform fossa, postcricoid region, and posterior pharyngeal wall with TNM stage cT3-4aN0-2M0(AJCC 7th).
. Able to understand and willing to sign a written informed consent document.
. Age≥ 18 and≤ 70 years.
. Male or female.
. Performance status of ECOG 0-2.
. Expected lifetime \> 6 months.
. Normal blood test, hepatic and renal functions. Normal hearing. Blood test: WBC≥4.0×109/L，ANC≥2.0×109/L，PLT≥100×109/L，HGB≥100g/L；Hepatic function: ALT、AST\< upper limit of normal. Kidney function: Serum creatinine \< upper limit of normal value, and creatinine clearance rate ≥ 60 ml/min（Cockcroft-Gault formula）. Cardiac ultrasonography left ventricular ejection fraction \>50%.
. No prior allergic reaction to biological agents and/or ingredient in the drug.
Exclusion criteria
. Patients with cervical lymph node cN3.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Have a history of other cancers in the past five years, radical or untreated prostate cancer (Gleason score ≤ 6), or complete treatment of breast ductal carcinoma in situ, except for patients with cured skin basal cell carcinoma or squamous cell skin cancer.
. Patients with target lesions who have received radiation therapy or surgery (except biopsy).
. Patients who have previously used chemotherapy, immunotherapy, or biological targeted therapy for primary tumors
. Patients who have participated in other clinical trials within 4 weeks before the test.
. Any of the following conditions in the first 6 months of random grouping: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, patients with transient ischemic attack or symptomatic pulmonary embolism.
. Patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg);
. Patients with grade I or above coronary heart disease, arrhythmia (including men with a QTc interval \>450 ms, women \>470 ms), and cardiac insufficiency.