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.

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Patients with cervical lymph node cN3.
✕. 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.

Overall Response Rate

Timeframe: 9 weeks

NCT IDNCT04156698

SponsorEye & ENT Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-16

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Patients with cervical lymph node cN3.
✕. 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.